Q3 2025 Glaukos Corp Earnings Call

Speaker #3: Ladies and gentlemen , thank you for standing by . My name is Colby , and I'll be your conference operator today . At this time , I welcome you to the glucose Corporation's third quarter 2020 financial results conference call .

Speaker #3: Copies of the company's press release and quarterly summary document , both issued after the market closed today , are available at . All lines have would like to on mute to prevent any background noise .

Speaker #3: And after the speaker's remarks , there will be a question and answer session . If you would like to ask a question at that time , please press star .

Speaker #3: Then press the number one on your telephone keypad. If you would like to withdraw your question at any time, please press star one again.

Speaker #3: Please note this call is being recorded and an archived replay will be available online in the Investor Relations section at . GLAUKOS Corp .

Speaker #3: I'll now turn the call over to Chris Lewis , Vice President of Investor Relations and Corporate Affairs .

Chris Lewis: I'll now turn the call over to Chris Lewis, Vice President of Investor Relations and Corporate Affairs.

Speaker #4: Thank you , and good afternoon . Joining me is chairman and CEO Tom Burns , president and CEO Joe Gilliam , and CFO Alex Thurman .

Chris Lewis: Thank you and good afternoon. Joining me today are Glaukos Chairman and CEO Thomas Burns, President and COO Joe Gilliam, and CFO Alex Thurman. Similar to prior quarters, the company has posted a document on its investor relations website under the Financials and Filings Quarterly Results section. Titled Quarterly Summary, this document is designed to be read by investors before the regularly scheduled quarterly conference call. To ensure ample time and opportunity to address everyone's questions, we request that you limit yourself to one question and one follow up. If you still have additional questions, you may get back into the queue. Please note that all statements other than statements of historical facts made on this call that address activities, events or developments we expect, believe or anticipate will or may occur in the future are forward-looking statements.

Speaker #4: Similar to prior company has posted a document on its investor relations website under the financials and filings Quarterly Results section titled Quarterly Summary .

Speaker #4: This document is designed to be read by investors before the regularly scheduled quarterly conference call to ensure ample time and opportunity address everyone's questions .

Speaker #4: We request that you limit yourself to one question and one follow up . If you have additional questions , you may get back into the queue .

Speaker #4: Please note that all statements, other than statements of historical facts made on this call, that address activities, events, or developments we expect, believe, or anticipate will or may occur in the future are forward-looking statements.

Speaker #4: These include statements about our plans , objectives , strategies and prospects regarding , among other things , our sales , products , pipeline technologies and clinical trials .

Chris Lewis: These include statements about our plans, objectives, strategies and prospects regarding, among other things, our sales, products, pipeline technologies and clinical trials, U.S. and international commercialization, market development efforts, product approvals, the efficacy of our current and future products, competitive market position, regulatory strategies and reimbursement for our products, financial condition and results of operations, as well as the expected impact of general macroeconomic conditions, including foreign currency fluctuations, on our business and operations. These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements.

Speaker #4: Us and international commercialization , market development efforts , approvals , the efficacy of our current and future products , competitive market position , regulatory strategies , and reimbursement for our products .

Speaker #4: Financial condition and results of operations . As well as the expected impact of general macroeconomic conditions , including foreign currency fluctuations on our business and operations .

Speaker #4: These statements are based on current expectations about future events affecting us and are subject to risks, uncertainties, and factors relating to our operations and business environment.

Speaker #4: All of which are difficult to predict, and many of which are beyond our control. Therefore, they may cause our actual results to differ materially from those expressed or implied by forward-looking statements.

Speaker #4: Please review today's press release and our recent SEC filings . For more information about these risk factors . You'll find these documents in the investor section of our website at .

Chris Lewis: Please review today's press release and our recent SEC filings for more information about these risk factors. You'll find these documents in the Investors section of our website at www.glaukos.com. Finally, please note that during today's call we will also discuss certain non-GAAP financial measures including results on an adjusted basis. We believe these financial measures can facilitate a more complete analysis and greater transparency into Glaukos ongoing results of operations, particularly when comparing underlying results from period to period. Please refer to the tables in our earnings press release available in the Investor Relations section of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure. With that, I will turn the call over to Glaukos Chairman and CEO Thomas Burns.

Speaker #4: Finally , please note that during today's call , we will also discuss certain non-GAAP financial measures , including results on an adjusted basis .

Speaker #4: We believe these financial measures can facilitate a more complete analysis and greater transparency in the ongoing results of operations , particularly when comparing underlying results from period to period .

Speaker #4: Please refer to the tables in our earnings press release available in the Investor Relations section of our website for a reconciliation of these measures to their most directly comparable GAAP financial measure.

Speaker #4: With that, I will turn the call over to Glaukos Corp Chairman and CEO Thomas Burns.

Speaker #5: Okay . Thanks , Chris . Good afternoon to everyone , and thank you all for joining us today . In addition to discussing our record third quarter results today , we're also excited about an update on our groundbreaking advancement in corneal cross-linking for the treatment of keratoconus .

Thomas Burns: Okay, thanks Chris. Good afternoon to everyone and thank you all for joining us today. In addition to discussing our record third quarter results today, we're also excited to provide an update on Epioxa, our groundbreaking advancement in corneal cross-linking for the treatment of keratoconus following the FDA approval that we announced last week. Let's first start with the record quarter. Today Glaukos Corporation reported record third quarter consolidated net sales of $133.5 million, up 38% on a reported basis or 37% on a constant currency basis versus the year-ago quarter. As a result of our strong performance, we are raising our full year 2025 net sales guidance range to $490 to $495 million compared to $480 to $486 million previously.

Speaker #5: Following the FDA approval that we announced last week . Let's first start with the record quarter today . Reported record third quarter consolidated net sales of 133.5 million , up 38% on a reported basis , or 37% on a constant currency basis , versus the year ago quarter .

Speaker #5: As a result of our strong performance , we are raising our full year 2025 net sales guidance range to 490 to 495 million , compared to 480 to 486 million previously .

Speaker #5: Our third quarter record results reflect a sustained growth acceleration in our business , driven by growing TR adoption and utilization , along with our broader interventional glaucoma , or IG initiatives globally within our US glaucoma franchise , we delivered record third quarter net sales of 80.8 million on strong year over year growth of 57% , driven by growing contributions from high dose TR , which generated sales of approximately $40 million in the third quarter .

Thomas Burns: Our third quarter record results reflect a sustained growth acceleration in our business driven by growing iDose TR adoption and utilization along with our broader intervention of glaucoma, or IG, initiatives globally. Within our U.S. glaucoma franchise, we delivered record third quarter net sales of $80.8 million on strong year-over-year growth of 57% driven by growing contributions from iDose TR, which generated sales of approximately $40 million in the third quarter. iDose TR, a first-of-its-kind intracameral procedural pharmaceutical designed to continuously deliver glaucoma drug therapy for up to three years, continues to build commercial momentum supported by positive clinical outcomes and surgeon feedback that reaffirms our view that with the launch of iDose TR we are pioneering a brand new therapeutic category that has the potential to reshape glaucoma management as we know it.

Speaker #5: Idose TR , a first of its kind intracameral procedural pharmaceutical designed to continuously deliver glaucoma drug therapy for up to three years , continues to build commercial momentum , supported by positive clinical outcomes and surgeon feedback that reaffirms our view that we .

Speaker #5: The launch of Idose TR. We are pioneering a brand new therapeutic that has the potential to reshape glaucoma management as we know it today.

Thomas Burns: Today, our teams continue to make great progress in the execution of our detailed launch plans for iDose TR and we're encouraged with the continuing growing momentum. Moving on, our international glaucoma franchise delivered net sales of $29.4 million on a year-over-year growth of 20% on a reported basis and 17% on a constant currency basis. This strong growth was once again broad-based as we continue to scale our international infrastructure and execute our plans to drive things forward as a standard of care in each region and major market in the world. Last month, we were pleased to commence commercial launch activities for iStent infinite in our key European markets at the ESCRS Annual Meeting in Copenhagen.

Speaker #5: Our teams continue to make great progress in the execution of our detailed launch plans for Idose TR , we're encouraged with the continuing growing momentum .

Speaker #5: Moving on , our international glaucoma franchise delivered net sales of 29.4 million on a year over year growth of 20% on a reported basis , and 17% on a constant currency basis .

Speaker #5: This strong growth was once again broad-based, as we continue to scale our international infrastructure and execute our plans to drive makes forward as a standard of care in each region and major market in the world.

Speaker #5: Last month , we were pleased to commence commercial launch activities for Eystein Infinite in our key European markets . As the Escrs annual meeting in Copenhagen , surgeons interest levels for Iceland infinite were very high during the meeting , reaffirming our view that EU , MDR certification provides an infinite will help us not only maintain and grow our presence in Europe , but also advance and accelerate our broader ECG initiatives globally .

Thomas Burns: Surgeons' initial interest levels for iStent infinite were very high during the meeting, reaffirming our view that EU MDR certification, Preserflo MicroShunt, and iStent infinite will help us not only maintain and grow our presence in Europe, but also advance and accelerate our broader IG initiatives globally in the years to come. Finally, our Corneal Health franchise delivered net sales of $23.3 million on year-over-year growth of 13%, including Photrexa net sales of $20.3 million. As discussed previously, our third quarter results reflect the continued impact of Photrexa realized revenues as a result of our entry as a company into the Medicaid Drug Rebate Program, or MDRP.

Speaker #5: In the years to come . And finally , our corneal health franchise delivered net sales of 23.3 million on year over year growth of 13% , Photrexa net sales of 20.3 million .

Speaker #5: As discussed previously, our third quarter results reflect the continued impact of Photrexa realized revenues as a result of our entry as a company into the Medicaid Drug Rebate Program, or MDP.

Speaker #5: Our record third quarter results reflect strong execution against our key key strategic priorities testament to our evolution into a more diversified ophthalmic leader with transformational growth drivers that span across multiple geographies and disease states .

Thomas Burns: Our record third quarter results reflect strong execution against our key strategic priorities and are a testament to our evolution into a more diversified ophthalmic leader with transformational growth drivers that span across multiple geographies and disease states as we advance the standard of care in glaucoma and rare disease with iDose TR and Epioxa. Beyond that, we continue to advance a robust pipeline that supports our long-term best-in-class growth potential while remaining disciplined in capital allocation, focusing on ROI-driven investments and operational efficiency. This quarter, we saw continued gross margin accretion and maintain a strong balance sheet with $278 million in cash and no debt. Now let's shift to our Corneal Health pipeline.

Speaker #5: As we advance the standard of care in glaucoma and rare disease with Idose , TR and Adoxa . Beyond that , we continue to advance a robust pipeline that supports our long term best in class growth potential while remaining disciplined in capital allocation , focusing on ROI driven investments and operational efficiency .

Speaker #5: This quarter , we saw continued gross margin accretion and maintain a strong balance sheet with $278 million in cash and no debt . Now let's shift shift to our corneal health pipeline .

Speaker #5: As you know , last week we were delighted to announce the FDA approval of OXA , a groundbreaking advancement in corneal cross-linking for the treatment of keratoconus , a rare sight threatening disease that is currently far too often undiagnosed and untreated .

Thomas Burns: As you know, last week we were delighted to announce the FDA approval of Epioxa, a groundbreaking advancement in corneal cross-linking for the treatment of keratoconus, a rare sight-threatening disease that is currently far too often undiagnosed and untreated. This approval marks a significant milestone for Glaukos Corporation and ushers in a new standard of care for keratoconus patients and practitioners with the first and only FDA-approved topical drug therapy that does not require removal of the corneal epithelium, the outermost layer of the front of the eye. As a reminder, Epioxa utilizes a proprietary combination of an oxygen-enriched novel therapeutic that is bioactivated by UV light in an incision-free procedure. It is as a result of more than a decade of research focused on slowing or halting the progression of keratoconus while significantly improving patient comfort and minimizing recovery time.

Speaker #5: This approval marks a significant milestone for glaukos and ushers in a new standard of care for keratoconus patients and practitioners . With the first and only FDA approved topical drug therapy that does not require removal of the corneal epithelium .

Speaker #5: The outermost layer of the front eye . As a reminder , Oxy utilizes a proprietary combination of an oxygen enriched , novel therapeutic that is bioactivated by UV light in an incision free procedure .

Speaker #5: It is a result of more than a decade of research focused on slowing or halting the progression of keratoconus , while significantly improving patient comfort and recovery time .

Speaker #5: To provide a new way forward for patients afflicted with this sight threatening , rare disease , the FDA approval is based on results from two prospective , multicenter , double masked phase three pivotal trials that randomized a total of over 400 patients , both trials successfully achieved their pre-specified primary efficacy endpoints and demonstrated favorable safety profiles .

Thomas Burns: To provide a new way forward for patients afflicted with this sight-threatening rare disease, the FDA approval is based on results from two prospective multicenter double-masked phase 3 pivotal trials that randomized a total of over 400 patients. Both trials successfully achieved their pre-specified primary efficacy endpoints and demonstrated favorable tolerability and safety profiles. Keratoconus is a debilitating eye condition characterized by progressive thinning and weakening of the cornea that is often most aggressively advancing in patients under the age of 30. If left untreated, it can lead to loss of visual function and even blindness and is one of the leading causes of corneal transplants in the United States. Approximately 90% of cases of keratoconus are bilateral and as many as 20% of untreated keratoconus patients ultimately require a corneal transplant.

Speaker #5: Keratoconus is a debilitating eye condition characterized by progressive thinning and weakening of the cornea that is often most aggressively advancing in patients under the age of 30. If left untreated, it can lead to loss of visual function and even blindness, and is one of the leading causes of corneal transplants in the United States.

Speaker #5: Approximately 90% of cases of keratoconus are bilateral , and as many as 20% of untreated keratoconus patients . Ultimately require a corneal transplant .

Speaker #5: Conventional keratoconus treatments, such as eyeglasses or contact lenses, address visual symptoms only and do not slow or halt underlying disease progression.

Thomas Burns: Conventional keratoconus treatments such as eyeglasses or contact lenses address visual symptoms only and do not slow or halt underlying disease progression. Before we discuss our plans for Epioxa, it's important to understand the historical journey of Photrexa, our first-generation cross-linking therapy that, unlike Epioxa, requires the removal of the corneal epithelium. The FDA approval of Photrexa as an orphan drug was a major breakthrough back in 2016 as it became the first and only FDA-approved pharmaceutical therapy shown to slow or halt keratoconus progression. Following our nearly $500 million acquisition of Avedro in 2019, we have subsequently deployed several hundred million dollars in commercial and R&D investments to grow our corneal health franchise, driving new clinical trials, expanding our sales force and commercial reach, strengthening market access capabilities, and enhancing patient education and support programs.

Speaker #5: Before we discuss our plans for MPCa , it's important to understand the historical journey of Otrexup . Our first generation crosslinking therapy that , unlike epi oxa , requires the removal of the corneal epithelium .

Speaker #5: The FDA of Photrexa as an orphan drug was a major breakthrough back in 2016 , as it became the first and only FDA approved pharmaceutical therapy shown to slow or halt care to cause progression .

Speaker #5: Following our nearly half billion dollar acquisition of Avedro in 2019 , we have subsequently deployed several hundred million dollars in commercial and R&D investments to our corneal health franchise , driving new clinical trials , expanding our sales force , and commercial reach , strengthening market capabilities and enhancing patient education and support programs .

Speaker #5: These efforts have successfully resulted in Photrexa becoming the standard of care as excellent real world outcomes have helped preserve vision for tens of thousands of patients .

Thomas Burns: These efforts have successfully resulted in Photrexa becoming the standard of care as excellent real-world outcomes have helped preserve vision for tens of thousands of patients while our disciplined commercial execution has delivered meaningful progress and our investments have made real impact on patients' lives. Six years later, the unfortunate reality is that access to proper care still remains far too limited, evidenced by the fact that we are still only treating about 10,000 patients annually with Photrexa today. We estimate fewer than one in five actively diagnosed unstable keratoconus patients are getting access to Photrexa today and many more are never diagnosed at all, an unacceptable reality for patients that we must change moving forward. To make matters worse, only 13% of treated patients are under the age of 18, which is when many patients are most vulnerable to significant disease progression and vision loss.

Speaker #5: While our disciplined commercial execution has delivered meaningful progress and our investments have made real impact on patient lives for the past six years , the unfortunate reality is that the access to proper care still remains far too limited , evidenced by the fact that we are still only treating about 10,000 patients annually with Photrexa today , we estimate fewer than 1 in 5 actively diagnosed unstable keratoconus .

Speaker #5: Patients are getting access to photrexa today , and many more are never diagnosed at all . And unacceptable reality for patients that we must change .

Speaker #5: Moving forward, to make matters worse, only 13% of treated patients are under the age of 18, which is when many patients are most vulnerable to significant disease progression and vision loss.

Speaker #5: Further , given the invasive nature and extended recovery associated with the current procedure , many patients elect to delay or defer treatment . We estimate that as many as many as 40% of confirmed cases delay or decline for therapy , including procedures involving treated patients .

Thomas Burns: Further, given the invasive nature and extended recovery associated with the current Photrexa procedure, many patients elect to delay or defer treatment. We estimate that as many as 40% of confirmed cases delay or decline Photrexa therapy, including procedures involving treated patients. This is simply not good enough for patients and we are determined to do better for this rare disease community. Like other rare diseases, we believe there are several key factors contributing to why keratoconus remains too often undiagnosed and untreated today, including 1 lack of awareness and under diagnosis, 2 misdiagnosis and a focus on managing symptoms rather than proactively treating the underlying disease, and 3 a burdensome and lengthy patient journey marked with reimbursement hurdles and fragmented care pathways. The FDA approval of Epioxa marks a pivotal moment, introducing the first incision-free treatment for keratoconus and offering a groundbreaking new therapy for patients.

Speaker #5: Second thigh this is simply not good enough for patients , and we are determined to do better for this rare disease community . Like other rare diseases , we believe there are several key factors contributing to why keratoconus remains too often undiagnosed and untreated .

Speaker #5: Today photrexa , including one . Lack of awareness and underdiagnosis , two misdiagnosis and a focus on managing symptoms rather than proactively treating the underlying disease .

Speaker #5: And three a burdensome and lengthy patient journey marked with reimbursement hurdles and fragmented care pathways . The FDA approval of epi marks a pivotal , pivotal moment .

Speaker #5: Introducing the first incision free treatment for keratoconus and offering a groundbreaking new therapy for patients . Just as important , it gives us the opportunity to reset and redefine our go to market approach to better address this sight threatening disease and truly expand patient access .

Thomas Burns: Just as important, it gives us the opportunity to reset and redefine our go-to-market approach to better address this sight-threatening disease and truly expand patient access. With this approval, we plan to substantially increase our investments in patient awareness and access while addressing the long-standing challenges of under diagnosis and under treatment that have affected this rare disease community. Our new approach includes significantly enhanced awareness, education, and detection campaigns driven by increased engagements with the optometric community to establish KC detection centers, the development of a handheld KC screening device, and expanded advocacy partnerships alongside new patient education efforts to identify and reach patients earlier. To ensure patients move seamlessly from awareness to clinical diagnosis and treatment efficiently, we will establish a network of engaged ODs and MDs and committed Epioxa sites of care that maintain the sense of urgency that these vulnerable patients deserve.

Speaker #5: With this approval, we plan to substantially increase our investments in patient awareness and access while addressing the longstanding challenges of underdiagnosis and undertreatment that have affected this rare disease.

Speaker #5: Community: Our new approach includes significantly enhanced awareness, education, and detection campaigns driven by increased engagement with the optometric community to establish Casey Detection Centers, the development of a handheld Casey screening device, and expanded advocacy partnerships alongside new patient education efforts to identify and reach patients.

Speaker #5: Earlier, to ensure patients move seamlessly from awareness to clinical diagnosis and treatment efficiently, we will establish a network of engaged ODS and MDS, and committed EPI care that maintains the sense of urgency that these vulnerable patients deserve.

Speaker #5: In parallel , we will launch comprehensive patient services and support programs through our Patient Access Liaison Teams to streamline care coordination , demystify the insurance approval process , and advance covered decisions where possible .

Thomas Burns: In parallel, we will launch comprehensive patient services and support programs through our Patient Access Liaison teams to streamline care coordination, demystify the insurance approval process, and advance coverage decisions where possible. These efforts are designed to support patients and families at every stage, from awareness and diagnosis through ongoing treatment, making the entire journey as seamless, efficient, and patient friendly as possible. This approval is a culmination of unrelenting research, development, and clinical efforts, and I want to thank our dedicated employees who have put in countless hours to make this approval a reality. We are also deeply grateful to the clinical investigators and participants in the clinical trials who played instrumental roles in bringing Epioxa to the United States. Despite being a relatively young company, Glaukos has invested over $1 billion in R&D over the years to develop a robust pipeline focused on chronic and rare ophthalmic diseases.

Speaker #5: These efforts are designed to support patients and families at every stage from awareness and diagnosis , through ongoing treatment , making the entire journey as seamless , efficient , and patient friendly as possible .

Speaker #5: This approval is a culmination of unrelenting research, development, and clinical efforts, and I want to thank our dedicated employees who have put in countless hours to make this approval a reality.

Speaker #5: We are also deeply grateful to the clinical investigators and participants in the clinical trials who played instrumental roles in bringing EPI access to the United States .

Speaker #5: Despite being a relatively young company , Glaukos has invested over $1 billion in R&D over the years to develop a robust pipeline focused on chronic and rare ophthalmic diseases .

Speaker #5: Our continued investment in R&D remains best in class , underscoring our commitment to going first and advancing the standard of care for ophthalmic patients worldwide into the future .

Thomas Burns: Our continued investment in R&D remains best in class, underscoring our commitment to going first and advancing the standard of care for ophthalmic patients worldwide into the future. We also just broke ground on a new 200,000 square foot research, development, and manufacturing facility in Huntsville, Alabama to support long-term growth and innovation, including the eventual production of Epioxa. As we hope you can see from our comments today, we are very excited by the significant potential Epioxa offers to patients living with keratoconus and believe it will deliver exceptional value to patients, providers, and the healthcare system. We've had several meaningful, informative conversations with key members of the physician and patient advocacy communities regarding this value in relation to pricing. Our approach for Epioxa reflects our commitment to responsible innovation, balancing clinical value, cost effectiveness, and patient access.

Speaker #5: We also just broke ground on a new 200,000 square foot research , development and manufacturing facility in Huntsville , Alabama , to support long term growth and innovation , including the eventual production of epi , OXA .

Speaker #5: As we hope you can see from our comments today , we are very excited by the significant potential at of patients living with keratoconus and believe it will deliver an exceptional value to patients , providers and the healthcare system .

Speaker #5: We've had several meaningful and informative conversations with key members of the physician and patient advocacy communities regarding this value in relation to pricing.

Speaker #5: Our approach for EPI reflects our commitment to responsible innovation , balancing clinical value , cost effectiveness , and patient access . These principles help inform our pricing decision , which also reflects the significant investments we've made thus far and those we plan to make going forward for this rare disease .

Thomas Burns: These principles help inform our pricing decision, which also reflects the significant investments we've made thus far and those we plan to make going forward for this rare disease. After several years of thorough and thoughtful evaluation based on these factors and supported by a robust set of internal pharmacoeconomic and published health economic analysis, we have established a wholesale acquisition cost for Epioxa of $78,500, which represents a significantly lower price versus nearly all other rare disease drugs, including those within ophthalmology. This is particularly true when you consider that Epioxa is unique as a single administration therapy that is capable of slowing or halting disease progression in the vast majority of patients that are diagnosed with this sight-threatening disease.

Speaker #5: After several years of thorough and thoughtful evaluation based on these factors and supported by a robust set of internal pharmacoeconomic and published health , economic analysis , we have established a wholesale acquisition cost for epi of $78,500 , which represents a significantly lower price versus nearly all other rare disease drugs , including those with an ophthalmology .

Speaker #5: This is particularly true when you consider that this is unique as a single administration therapy that is capable of slowing or halting disease progression in the vast majority of patients diagnosed with this sight-threatening disease.

Speaker #5: We believe this not only provides a compelling value proposition for physicians and payers , but most importantly , enables us to make a fundamentally different investment in patient and provider education and awareness to enable more patients over time to be properly diagnosed and treated at a younger age .

Thomas Burns: We believe this not only provides a compelling value proposition for physicians and payers, but most importantly enables us to make a fundamentally different investment in patient and provider education and awareness to enable more patients over time to be properly diagnosed and treated at a younger age to preserve their needless loss of vision. Going forward, we anticipate Epioxa will be commercially available in the first quarter of 2026 under a miscellaneous J code, with a permanent J code established by July 2026. As with all pharmaceutical launches, initial patient access will be gated by our site of care, network deployment and typical payer adoption. We are investing in the infrastructure, teams and processes necessary to get Epioxa to as many patients as soon as possible in 2026 and beyond.

Speaker #5: To preserve their needless loss of vision . Going forward , we anticipate Epic will be commercially available in the first quarter of 2026 under a miscellaneous J code with a permanent J code established by July 2026 .

Speaker #5: As with all pharmaceutical launches , initial patient access will be gated by our site of care network deployment and typical payer adoption headwinds and hurdles .

Speaker #5: But we're investing in the infrastructure teams and processes necessary to get to as many patients as soon as possible in 2026 and beyond .

Speaker #5: Given the significant advancement for OXA represents in our commitment to ensuring patients gain access to state of the art , incision free treatment for this rare , debilitating disease , we made the decision to discontinue Photrexa commercial availability following a staged transition process in 2026 .

Thomas Burns: Given the significant advancement Epioxa represents in our commitment to ensuring patients gain access to state-of-the-art incision-free treatment for this rare debilitating disease, we made the decision to discontinue Photrexa commercial availability following a staged transition process in 2026. This transition will prioritize Epioxa as the primary treatment option, reflecting its safety, efficacy and superior patient experience. Photrexa will remain temporarily available for patients unable to access Epioxa due to coverage or geographic limitations and will transition all remaining patients through dedicated support programs designed to minimize disruption and ensure continuity of care. As we've discussed with the launch of Epioxa, a critical focus of ours is to improve patient access to the sight-saving keratoconus treatment.

Speaker #5: This transition will prioritize epi oxa as the primary treatment option , reflecting its safety , efficacy and superior patient experience , but will remain temporarily , temporarily available for patients unable to access Epyaxa due to coverage or geographic limitations and will transition all remaining patients through dedicated support programs designed to minimize disruption and ensure continuity of care .

Speaker #5: As we discussed with the launch of OXA , a critical focus of ours is to improve patient access to this sight saving keratoconus treatment .

Speaker #5: With that in mind , in addition to our new awareness campaign and patient support programs discussed earlier , we will also deploy a new financial co-pay assistance program for eligible patients and intend to have a comprehensive specialty pharma option available for customers at launch .

Thomas Burns: With that in mind, in addition to our new awareness campaign and patient support programs discussed earlier, we will also deploy a new financial copay assistance program for eligible patients and intend to have a comprehensive specialty pharma option available for customers at launch. Our cross-functional teams have been hard at work putting these methodical plans together for several years now, and we are ready and excited to commence execution and make a difference in the lives of these keratoconus patients. The enthusiasm and energy for this new therapy and launch is palpable throughout our organization. In summary, Epioxa represents not just a breakthrough in science, but a breakthrough in how we deliver on our promise to provide the best possible care to patients. Epioxa is more than a product. It's a reset moment and new way forward for keratoconus care.

Speaker #5: Our cross-functional teams have been hard at work putting these methodical plans together for several years now, and we are ready and excited to commence execution and make a difference in the lives of these keratoconus patients.

Speaker #5: The enthusiasm and energy for this new therapy and launch is palpable throughout our organization . In summary , Epyaxa represents not just a breakthrough in science , but a breakthrough in how we deliver on our promise to provide the best possible care to patients and is more than a product .

Speaker #5: It's a reset moment , a new way forward for keratoconus care . We're proud to lead the way once again in forging a new path to drive expanded patient access and enhanced treatment standards .

Thomas Burns: We're proud to lead the way once again in forging a new path to drive expanded patient access and enhanced treatment standards. Finally, as discussed earlier, we are raising our 2025 revenue guidance to $490 million to $495 million versus $480 million to $486 million previously. To reflect our third quarter outperformance and continued underlying momentum, we are also introducing a highly preliminary 2026 revenue guidance range of $600 million to $620 million. This preliminary outlook factors in our expectations as it relates to the continued commercial rollout for iDose TR, the surgical MIGS landscape, our international glaucoma franchise as well as our Corneal Health franchise as we launch Epioxa and transition from Photrexa. We expect to refine this guidance range and provide additional commentary during our fourth quarter 2025 earnings call expected to be held in February 2026.

Speaker #5: Finally , as discussed earlier , we are raising our 2025 revenue guidance to 490 to 495 million versus 480 to 486 million previously to reflect our third quarter outperformance and continued underlying momentum .

Speaker #5: We are also introducing a highly preliminary 2026 revenue guidance range of 600 million to 620 million . This preliminary outlook factors in our expectations as it relates to the continued commercial rollout for Idose TR , the surgical makes landscape our international glaucoma franchise as well as our corneal health franchise .

Speaker #5: As we launch EPI and transition from Photrexa, we expect to refine this guidance range and provide additional commentary during our fourth quarter 2020 call.

Speaker #5: Expected to be held in February 2026. In conclusion, our record quarter highlights the strength of our strategy and execution as we continue evolving into a diversified leader with multiple growth drivers.

Thomas Burns: In conclusion, our record quarter highlights the strength of our strategy and execution as we continue evolving into a diversified leader with multiple growth drivers. iDose TR is already driving meaningful growth today and we expect Epioxa will begin to contribute in 2026 and beyond as our patient-oriented initiatives take hold. Combined with our robust pipeline that spans glaucoma, rare disease and retina in particular, along with our disciplined investment and strong balance sheet, we're well positioned to sustain our growth momentum and advance our mission to transform vision therapies for the benefit of patients worldwide. With that, I'll open the call for questions. Operator.

Speaker #5: Idose TR is already driving meaningful growth today, and we expect it will begin to contribute in 2026 and beyond as our patient-oriented initiatives take hold.

Speaker #5: Combined with our robust pipeline that spans glaucoma, rare diseases, and retina in particular, along with our disciplined investment in a strong balance sheet, we're well positioned to sustain our growth momentum and advance our mission to transform vision therapies for the benefit of patients worldwide.

Speaker #5: So with that, I'll open the call for questions. Operator?

Speaker #3: Thank you . We will now begin the question and answer session . If you would like to ask a question , please press star .

Chris Lewis: Thank you. We will now begin the question and answer session. If you'd like to ask a question, please press Star, then the number one on your telephone keypad to raise your hand and enter the queue. If you'd like to withdraw your question at any time, simply press Star one again. Thank you. Your first question comes from the line of Tom Stephan from Stifel. Your line is open.

Speaker #3: Then the number one on your telephone keypad to raise your hand and enter the queue . If you'd like to withdraw your question at any time .

Speaker #3: Simply press star one . Again , thank you . Your first question comes from the line of Tom Stephan from Stifel . Your line is open .

Speaker #6: Great . Hey , guys , thanks for taking the questions . I'll start off with Idose and I wanted to ask about the CAC meeting .

[Analyst]: Great. Hey guys, thanks for taking the questions. I'll start off with Epioxa and I wanted to ask about the CAC meeting. Tom or Joe, maybe if you can discuss just the impetus or the rationale of the CAC, maybe from what you have gathered in conversations with the MACs and then maybe more importantly, talk to us about sort of what your views are on the potential outcomes here.

Speaker #6: Tom or Joe , maybe if you can discuss , you know , just the impetus or the rationale of the CAC . You know , maybe from what you have gathered in conversations with the Max and then maybe more importantly , you know , talk to us about sort of what your views are on , on the potential outcomes here .

Speaker #7: Sure . Hi Tom , it's Joe . I'll start off and as always , Tom can also add in the comments he's got at the end here .

Operator: Sure.

Joe Gilliam: Hi Tom, it's Joe. I'll start off, and as always, Tom can also add in the comments he's got at the end here. I'd say that from a rationale perspective and maybe how we're viewing it from a macro standpoint is we see this really as the step in the process of educating these MACs and really educating them on, number one, the significant unmet need that iDose meets for glaucoma patients, as you all know. Two, and as importantly, the robust FDA and peer-reviewed level one data evidence that supports its proper utilization in the care continuum. Three, ultimately really establishing the patient access that our glaucoma patients and physicians deserve around the product. Clearly, if you think about this moving forward, you can make arguments both ways. We've seen some of that play out obviously in the early commentary from the investor community.

Speaker #7: I would say that from a rational perspective and maybe how we're viewing it from a macro standpoint is we see this really as a step in the process of educating these these max and really educating them on .

Speaker #7: Number one , the significant unmet need that that idose meets for glaucoma patients . As you all know . Two and as importantly , the robust FDA and peer reviewed level one data evidence that supports its proper utilization in the care continuum and and three , ultimately really establishing the patient access that our glaucoma patients and physicians deserve around the product .

Speaker #7: And , you know , clearly , if you think about this moving forward , you can make arguments both ways . And we've seen some of that play out .

Speaker #7: Obviously , in the early commentary from the investor community . But in general , we're pretty confident that the considerable data behind Idose as an FDA approved pharmaceutical , more high quality evidence has been generated to support this pharmaceutical than virtually all of the glaucoma device solutions combined , including in at least 15 peer reviewed publications .

Joe Gilliam: In general, we're pretty confident that the considerable data behind iDose as an FDA-approved pharmaceutical, more high-quality evidence has been generated to support this pharmaceutical than virtually all of the glaucoma device solutions combined, including in at least 15 peer-reviewed publications, all that support and supported the FDA approval and the label. That is, when you look at it, largely consistent with other pharmaceutical therapies in glaucoma. I think there's a handful of different paths that can emerge as we go forward. I think what's most important is that for these MACs, they're taking a step to make sure they understand and are educated on what we already know, which is that iDose is a game-changing solution with a lot of evidence and data behind it to change the treatment paradigm associated with glaucoma patients here in the U.S.

Speaker #7: In all that support and supported the FDA approval and the label . That is , when you look at it , largely consistent with other pharmaceutical therapies in glaucoma .

Speaker #7: So I think there's a handful of different paths that can emerge as we go forward . But I think what's most important is , is that for these , Max , they're taking a step to make sure they understand and are educated on what we already know , which is that Idose is a game changing solution with a lot of evidence and data behind it to change the treatment paradigm associated with glaucoma patients here in the United States .

Speaker #7: So from that standpoint , we look forward to having that engagement . And from them moving forward from a from a more educated basis to adjudicate the claims that come their way .

Joe Gilliam: From that standpoint, we look forward to having that engagement and for them moving forward from a more educated basis to adjudicate the claims that come their way.

Speaker #5: I'll just add , if I can , to Joe's . Let's talk about some of the data that we already have in hand .

Thomas Burns: I'll just add if I can to Joe's. Let's talk about some of the data that we already have in hand. We've got two phase three clinical trials which you're all aware of, to establish the NDA submission and PMA approval with over 1,000 patients that are validating the use of iDose in standalone glaucoma patients. More importantly, I think we've been prescient also as well as conducting a single-arm prospective study in combination with cataract surgery, which showed demonstrably powerful decreases in your ocular pressure, 11.3 millimeters from pre-treatment. We're conducting a prospective level one study of iDose in combination with cataract versus cataract surgery alone. I think we were smart in also conducting a study that we're in the process of enrolling today, which is iDose in combination with iStent infinite versus iStent infinite alone.

Speaker #5: So we've got two phase three clinical trials which are all aware of to establish the the NDA submission and PMA approval . With over a thousand patients that are validating the use of Idose in standalone glaucoma patients and more importantly , I think we've been prescient also , as well as as conducting a single arm prospective study in combination with cataract surgery , which showed demonstrably powerful decreases in intraocular pressure .

Speaker #5: 11.3mm from pre-treatment means . We're conducting a prospective level one study of idose in combination with cataract versus cataract surgery alone . And we're also , I think we were smart and also conducting study that we're in the process of of enrolling today , which is Eidos in combination with an infinite versus iustin infinite alone .

Speaker #5: And so we expect those studies will validate what we expect to see , which is incremental and cumulative advantage of using these different products .

Thomas Burns: We expect those studies will validate what we expect to see, which is incremental and cumulative advantage of using these different products, all of which should be conscribed and used under the current label that provided.

Speaker #5: All of which should be conscribed and used under the current label that provided .

Speaker #6: Got it . That's great . Really appreciate that color . And then my follow up is just on Oxa . And congrats on approval .

[Analyst]: Got it. That's great. Really appreciate that color. My follow up is just on Epioxa, and congrats on approval, maybe a quick two-parter. Can you just elaborate a bit on sort of your confidence in executing with this level of pricing just in terms of payer coverage and reimbursement? How should we be thinking about 2026 for corneal health just as we consider the moving parts with Epioxa ramping as well as Photrexa transitioning off? Thanks.

Speaker #6: Maybe a quick two parter . Can you can you just elaborate a bit on sort of your confidence in executing with this level of pricing , just in terms of payer coverage and reimbursement ?

Speaker #6: And then how should we be thinking about 2026 for corneal health , just as we consider the moving parts with EPI or ramping , as well as photrexa transitioning off .

Speaker #6: Thanks .

Speaker #7: Sure . Thanks , Tom . I think as it relates to the coverage and and continued access to or gaining access for the patients , I think like everything else , that's a process where there's education at the payer level around the the benefits associated with this therapy .

Operator: Sure.

Joe Gilliam: Thanks Tom. I think as it relates to the coverage and continued access to or gaining access for Epioxa patients, I think like everything else, that's a process where there's education at the payer level around the benefits associated with this therapy and the real cost associated with the continued progression of the disease. Ultimately, as you heard Tom mention, too often, these patients proceeding towards corneal transplants and other outcomes, let alone the continued impact from the visual impacts that keratoconus has on many of these patients. I think we'll engage in that process, we go through it. We're confident obviously that we have a best in class solution that works well for the patients afflicted with keratoconus. We look forward to engaging those conversations with the payer community as it relates to 2026.

Speaker #7: And , and the real cost associated with the continued progression of the disease . And ultimately , as you heard , Tom mentioned , the too often these patients proceeding towards corneal transplants and other outcomes , let alone the continuing impact from the visual impacts that that keratoconus has on many of these patients .

Speaker #7: So I think we'll engage in that process . We go through it . We're confident , obviously , that we have a best in class solution that works well for the patients afflicted with keratoconus .

Speaker #7: And and so we look forward to engaging those conversations with with the payer community relates to 2026 . It's part of the reason why we decided to give the preliminary guidance for the year is to make sure that that was factored in at a macro level , into the guidance in our expectations .

Joe Gilliam: It's part of the reason why we decided to give the preliminary guidance for the year is to make sure that that was factored in at a macro level into the guidance and our expectations. You heard Tom mention some of these, but as you think about Epioxa rolling out over the course of the year, we have work to do to obviously establish the site of care network, the drug availability itself, timing in the first quarter, the reality of having a miscellaneous code throughout the first half of the year, the process of payers just updating their systems for the J code in the second half of the year and alongside of that customers updating their contracts and generally what I'll call is the slow and methodical process of establishing proper payer coverage and patient access for any rare disease. Epioxa will be not dissimilar.

Speaker #7: You heard Tom mentioned some of these , but as you think about rolling out over the course of the year , we have work to do to obviously establish the site of care network .

Speaker #7: The drug availability itself , timing in the first quarter , the reality of having a miscellaneous code throughout the first half of the year , the the process of payers just updating their systems for the J code in the second half of the year , and alongside of that , customers updating their contracts .

Speaker #7: And generally what I'll call is the slow and methodical process of establishing proper payer coverage and patient access for any rare disease will be no, not dissimilar.

Speaker #7: So , you know , this is certainly one where we're expecting in the context of the way we think about the 2026 impact , that we will come out of the gate .

Joe Gilliam: This is certainly one where we're expecting, in the context of the way we think about the 2026 impact, that we will come out of the gate crawling before we walk, before we jog as we exit 2026.

Speaker #7: You know , crawling before we before we walk , before we jog , as we exit 2026 .

Speaker #3: Your next question comes from the line of Adam Mader from Piper Your line is open .

Chris Lewis: Your next question comes from the line of Adam Maeder from Piper Sandler. Your line is open.

Speaker #8: Hi . Good afternoon . Thank you for taking the questions and congrats on the great quarter . You know , maybe just kind of piggybacking a little bit on .

Joe Gilliam: Hi, good afternoon. Thank you for taking the questions and congrats on the great quarter. Maybe just kind of piggyback the preliminary $620 million for next year. That's a little bit above consensus at the midpoint and companies don't typically get to do so. As we think about.

Speaker #8: The preliminary guidance is $600 million to $620 million for next year. That's a little bit above consensus at the midpoint. And, you know, companies don't typically guide to net.

Speaker #8: And to so and as we think about the different kind of components , of that revenue range , I know versus the health .

[Analyst]: The different kind of components, you know.

Joe Gilliam: Of that revenue range versus health.

Speaker #8: Each of those segments and even if it's just as simple as should each of the different segments grow next year , that would be cool .

[Analyst]: Each.

Joe Gilliam: Of those segments, even if it's just as simple as should each of the different segments grow next year, that would be. Adam, you were breaking up pretty substantially, at least on our end throughout that. I believe that you were asking for more context or color around the guidance range of 2026 of $600 to $620 million and probably pushing a bit for a bit more granularity around the constituent parts of that. Assuming that I'm correct on that, I'll give you that answer, which is good.

Speaker #8: Thank you .

Speaker #7: So , Adam , were breaking up pretty substantially , at least on our end throughout that I believe that you were asking for more context or color around the guidance range of 2026 of 600 , 620 million and probably pushing a bit for a bit more granularity around the constituent parts of that .

Speaker #7: So assuming that I'm correct on that , I'll give you that answer , which is good . You know , I think as I mentioned before , felt like it was prudent with what we were announcing in terms of the approval , some of what Tom announced today to make sure that we established what I'll call as a highly preliminary view of of 2026 and to really anchor our anchor ourselves around what we think , entering into the into the year where we're at here in in October , our goal and our plan would be to provide more granular views by franchise during the fourth quarter call .

Joe Gilliam: I think as I mentioned before, we felt like it was prudent with what we were announcing in terms of the Epioxa approval, some of what Tom announced today, to make sure that we established what I'll call a highly preliminary view of 2026 and to really anchor ourselves around what we think entering into the end of the year, where we're at here in October. Our goal and our plan would be to provide more granular views by franchise during the fourth quarter call. What I can say from a macro standpoint is we feel confident in this early range and that a variety of paths through each of the franchises, if you will, U.S. Glaucoma, International Glaucoma, and certainly the Corneal Health franchise will enable us to meet the expectations of that $600 to $620 million range that we've established.

Speaker #7: But what I can say from a macro standpoint is confident in this early range in that a variety of paths through each of the franchises , if you will , us Glaucoma , international glaucoma , and certainly the corneal health franchise will enable us to to meet the expectations of that 600 to $620 million range that we've established .

Speaker #8: Understood . Color . There . And I wanted to ask for just a little bit more color around . Idaho's performance in the quarter .

Joe Gilliam: I wanted to ask for just a little bit more color around iDose TR's performance in the quarter. Really good number there. Did you—yes, that MAC that onboarded in early August, just any color of how iDose TR is ramping as we head into Q4. The second part of the question is really just around.

Speaker #8: You know , a really good number there , you know . Did you kind guess that that onboarded in early August , you know , just any color of how Idaho's you know , ramping as we head into Q4 and , you know , the second part of the question is really just around , you know , the utilization and kind of which patients are getting Eidos is this being done early in the standalone setting ?

Chris Lewis: You.

Joe Gilliam: Know, the utilization and kind of which patients are getting iDose. Is this being done early in the standalone setting? You know, how much is coming from combination with cataract? How much is with a, you know, a second MIG and thanks for taking the questions. Yeah, again, you're breaking up a little bit, but I think the question was largely around the iDose performance dynamics associated with that in the quarter and then a little bit more granularity on the breakdown of standalone versus combo cataract utilization. Obviously, we announced in the quarter approximately $40 million of sales. Really, iDose a very nice step up from where we've been running in the second quarter coming into the third. That I can say was broad based in terms of what drove it.

Speaker #8: much is coming from combination with cataract ? How much is with a , you know , a second MiG ? And thanks for taking the questions .

Speaker #7: Yeah . Again , Adam , you're breaking up

Speaker #7: but I think the question was largely around the Eidos performance dynamics associated with that in the quarter . And then You know , how more granularity on the on the breakdown of standalone versus combo cataract utilization .

Speaker #7: So obviously we we announced in the quarter approximately $40 million of sales for Eidos , a very nice step up from where we've been running in the second quarter .

Speaker #7: Coming into the third , that I can say was broad based in terms of what drove it . All of the Mac regions , if you will , contributed to that , to that growth , as did growing early commercial and advantage utilization was a part of a little bit , that .

Joe Gilliam: All of the MAC regions, if you will, contributed to that growth, as did growing early commercial and Med Advantage. Utilization was a part of that. We saw new doctors picking up. We saw some who had maybe been a part of early trying and trialing, now having maybe received their payments from 2024, starting to get back into providing iDose as a therapeutic option for their patients. It was really high quality. I would say, in terms of some of the contributions from, I couldn't hear you, but NGS obviously came online in August very early, positive signs there. Realistically, the quarter itself looked very much like in terms of its mix, what we'd seen in the second quarter where about 80% of the overall volumes were in the more established MAC regions, if you will, of Noridian, Novitas, and First Coast.

Speaker #7: We saw new doctors picking up . We saw some who had maybe been a part of early trying and trialing . Now having maybe received their payments from , starting to get back into providing Eidos .

Speaker #7: So a therapeutic option for their patients . So it was it was really high quality . And I would say , you know , in terms of some of the contributions from I couldn't hear you , but you know , NGS obviously came online in August very early .

Speaker #7: You know , positive signs there . But but realistically , the quarter itself looked very much like in terms of its mix , what we'd seen in the second quarter , where about 80% of the overall volumes were in the more established Mac regions , if you will , of Noridian , Novitas and First Coast .

Speaker #7: So, the growth balance was across the board, but the weighting was still towards the more established regions in the country, which is not a huge surprise at this point.

Joe Gilliam: The growth balance was across the board, but the weighting was still towards the more established regions in the country, which is not a huge surprise at this point with that NGS announcement. You wouldn't really expect to start seeing the impact of that until at best kind of the later part of this quarter and really as you start moving into next year. As it relates to the mix on the standalone versus combo cataract, as you know, that's not something we directly track. We obviously are providing iDose TR for the benefit of patients afflicted with glaucoma and how surgeons utilize that in the combination with anything else, including as a part of a combination cataract procedure, is not something that we know when it goes out the door.

Speaker #7: With that NGS announcement, you wouldn't really expect to start seeing the impact of that until, at best, kind of the later part of this quarter.

Speaker #7: And really , as you start moving into into next year as it relates to the mix on the standalone versus combo cataract , as you know , that's not something we directly track .

Speaker #7: We we we obviously are providing Idose TR for the benefit of patients afflicted with glaucoma . And how surgeons utilize that in the combination with anything else , including as a part of combination cataract procedure not something that we know when it goes out the door .

Speaker #7: Anecdotally , we know that those areas that have a little bit more established track record of of reimbursement and of professional that the rate of utilization in combo cataract surgery is growing , that makes sense .

Joe Gilliam: Anecdotally, we know that those areas that have a little bit more established track record of reimbursement and of professional fees, that the rate of utilization in combo cataract surgery is growing. That makes sense. Obviously that's meeting the surgeon many times where they're already at, which is treating the cataract and trying to take care of the glaucoma disease in parallel. We are seeing some growth in that in terms of the anecdotally of the overall mix. It's largely in those regions where you have more established reimbursement than some of the other MACs where we're a little bit further behind.

Speaker #7: Obviously , that's meeting the surgeon many times is where they're already at , which is treating the cataract and trying to take care of the glaucoma disease in parallel .

Speaker #7: So we are seeing some some growth in that in terms of the anecdotal of the overall mix , but it's largely in those regions where you have more established reimbursement than some of the other Macs , where we're a little bit a little bit further behind .

Speaker #3: Your next question comes from the line of Larry Biegelsen from Wells Fargo . Your line is open .

Chris Lewis: Your next question comes from the line of Larry Begelson from Wells Fargo. Your line is open.

Speaker #9: Good afternoon . Thanks for taking the question . I guess , Joe , I wanted to start with , you know what , for those of us who have followed this a long time , know that when photrexa when Avedro came out with the $3,000 or so .

[Analyst]: Good afternoon. Thanks for taking the question. Joe, I wanted to start with Epioxa. For those of us who have followed this a long time, know that for Photrexa, when Avedro came out with the $3,000 or so ASP, there was some pushback. You're obviously moving a lot higher here. What data are you going to use with payers that gives you the confidence that commercial payers will cover it? How are you thinking about the growth in the 10,000 patients I think you said earlier treated per year with Photrexa today? Over time do you expect to grow that or could you actually lose some patients to off-label corneal cross-linking treatments? I had one follow up.

Speaker #9: ASP , there was some pushback . So you're obviously moving a lot higher here . So what data are you going to use with payers that gives you the confidence that that commercial payers will cover it ?

Speaker #9: And how are you thinking about , you know , the growth in the 10,000 patients ? I think you said earlier treated per year with Photrexa today , over time , you know , do you expect to grow that or could you actually lose some patients to off label corneal cross-linking treatments ?

Speaker #9: And I had one follow up .

Speaker #7: Sure . I'll start . Larry and others can comment as we go forward here , but for for foxa , I think that first and foremost in in obviously the reset moment , as you heard Tom talk about this is an education process , just like you'll recall to your point , having been around with vitro back in the day , as they as they first reimbursement around keratoconus itself with photrexa is to remind the constituents that are out there , including the payer that this is a rare disease that , by definition , you reference that yourself .

Joe Gilliam: Sure, I'll start. Larry and others can comment as we go forward here, but for Epioxa I think that first and foremost, and obviously the reset moment, as you heard Tom talk about this, is an education process, just like you'll recall to your point, having been around with back in the day they first had reimbursement around keratoconus itself with Photrexa is to remind the constituents that are out there, including the payer community, that this is a rare disease, that by definition you reference it yourself when you're talking about 10,000 patients being treated. In fact, that's an uber rare disease and pretty consistent with the type of treatment numbers as we understand it from indications or for other rare disease therapies in ophthalmology, such as Oxybate or Tepezza for thyroid eye disease.

Speaker #7: When you're talking about 10,000 patients being treated . In fact , that's an Uber rare disease and pretty consistent with the type of treatment numbers .

Speaker #7: As we understand it from indications for other rare disease therapies and ophthalmology , such as oxervate or for thyroid eye disease . So when you compare from a payer perspective , the relative value of a single procedure that can slow or halt the disease progression of a condition like this , and you think about that patient population and the cost or the wholesale wholesale acquisition cost .

Joe Gilliam: When you compare from a payer perspective the relative value of a single procedure that can slow or halt the disease progression of a condition like this, and you think about that patient population and the cost or the wholesale acquisition cost that Tom talked about, I think you're going to find that it compares pretty favorably to the broader rare disease landscape, including that within ophthalmology. I think more broadly than that, the conversation is one of education around what it takes to make sure that you're responsibly innovating in a category like this for rare disease. What you have to do to drive meaningful change in awareness, in diagnosis, in detection and in patient access.

Speaker #7: As Tom talked about , I think you're going to find that compares very favorably to the broader rare disease landscape , including that within .

Speaker #7: I think more broadly than that , the conversation is one of education around what it takes to make sure that you're responsibly innovating in a category like this for rare And then what you have to do to drive meaningful change in awareness and diagnosis in detection and in patient access .

Speaker #7: As you heard Tom talk about this , is this is a different way of looking at the situation . But with one that we had to look inwardly and ask ourselves , what do we have to do to meaningfully change the outcomes that we're seeing in terms of too many patients not getting access to a site that threatening therapy in the form of photrexa .

Joe Gilliam: As you heard Tom talk about this is a different way of looking at the situation, but one that we had to look inwardly and ask ourselves, what do we have to do to meaningfully change the outcomes that we're seeing in terms of too many patients not getting access to a sight-threatening therapy in the form of Photrexa? As we move forward with Epioxa, that's exactly what we're committed to do. Now you asked about 10,000 patients. I have no doubt that in the early days, as you're working your way through the inevitable payer hurdles and the various things you have to do to drive education and get access through each individual payer, that we'll face some headwinds there. Clearly as we move forward, the whole reason for what we're doing is to meaningfully expand that number.

Speaker #7: As we move forward with epi oxa , that's exactly what we're committed to do . Now , you asked about 10,000 . 10,000 patients .

Speaker #7: I have no doubt that in the early days , as you're working your way through the inevitable , you know , payer hurdles in the various things you have to do to drive education and , and get access through each individual payer that will face some headwinds .

Speaker #7: There . But clearly , as we move forward , the whole reason for what we're doing is to meaningfully expand that number . And you heard Tom referenced that we today believe we're treating one in every five patients who have uncontrolled or unstable keratoconus with photrexa today .

Joe Gilliam: You heard Tom reference that we today believe we're treating one in every five patients who have uncontrolled or unstable keratoconus with Photrexa today. I hope that in the coming years we'll put a meaningful dent in getting to what was by definition an uber rare disease with 10,000 patients to what would be merely considered a rare disease in the 50,000 patient range. That's something that will be hard to work at, but it's not something that's going to be turned on overnight in 2026 for sure. It's the reason because each one of those patients deserve to get access to an FDA approved incision-free topical therapy that can arrest or certainly dramatically slow the progression of that disease.

Speaker #7: And so I hope that in the coming years , we'll put a meaningful dent in getting to what was , by definition , an Uber rare disease with 10,000 patients to what would be merely considered a rare disease in the 50,000 patient range .

Speaker #7: And that's something that we'll be hard at But it's not something that's going to be turned on overnight in 2026 , for sure .

Speaker #7: But it's the reason why each one of those patients deserves to get access to an FDA-approved, incision-free topical therapy that can arrest or certainly dramatically slow the progression of that disease.

Speaker #9: That's helpful , I guess , just for my follow up , it truly is related . I guess I'm just thinking ahead as many people probably are 27 , 28 , 29 .

[Analyst]: That's helpful, I guess, just for my follow up. It truly is related. I guess I'm just thinking ahead. As many people probably are, 2027, 2028, 2029, at $78,000 and 10,000 patients, and I assume 90% are done bilaterally, the numbers get pretty big. Is there anything else? I mean, could you be doing 20,000 eyes in 2027, Joe? Should we be using an ASP of $78,000 to help us frame that beyond 2026 for hopefully obvious reasons? These are big numbers.

Speaker #9: It's $78,000 and 10,000 patients . And I assume 90% are done bilaterally . The numbers get pretty big . Is there anything else ?

Speaker #9: I mean , could you be doing , you know , 20,000 eyes in 2027 ? Joe ? And , you know , should we be using an ASP of $78,000 to help us frame that beyond 26 for hopefully obvious reasons ?

Speaker #9: These are big numbers .

Speaker #7: Yeah . Well , first , I think you have to do a blended average over time . I wouldn't do 78,500 . Your in your long term models .

Joe Gilliam: Yeah. First, I think you have to do a blended average over time. I wouldn't do $78,500 in your long-term models. Obviously, we are a member of the Medicaid Drug Rebate Program. We do provide that discounting for that patient population as a part of this. When you think about a blended WAC, and we'll talk more about that as we actually get into making that drug available, I think we went far enough in terms of providing our preliminary views on 2026. I'm not going to go that far as you'd like in terms of 2027 and beyond. I've given you the bookend of what we're trying to target over a period of time in terms of meaningfully changing this for those patients.

Speaker #7: Obviously we are a member of the Medicaid drug rebate program . We do provide that discounting for that patient population . As a part of this .

Speaker #7: So when you think about a blended whack and we'll talk more about that as we actually get into making that that that drug available .

Speaker #7: I'm certainly I think we went far enough in terms of providing our preliminary views on 2026 . I'm not going to go up that far as you'd like in terms of 2027 and beyond .

Speaker #7: I've given you the bookend of what we're trying to target over a period of time in terms of meaningfully changing this for for those patients .

Speaker #7: And I would add that whatever you assume in our models over the course of the next several years , you should also assume requisite investments associated with what we're talking about here , to make sure that we're actually driving the awareness , the education detection necessary to achieve those outcomes that you're that you're talking about in 2027 and beyond .

Joe Gilliam: I would add that whatever you assume in our models over the course of the next several years, you should also assume requisite investments associated with what we're talking about here to make sure that we're actually driving the awareness, the education, and the detection necessary to achieve those outcomes that you're talking about in 2027 and beyond.

Speaker #3: Your next question comes from the line of Ryan Zimmerman from Btig . Your line is open .

Chris Lewis: Your next question comes from the line of Ryan Zimmerman from BTIG. Your line is open.

Speaker #10: Great . Can you hear me ? Okay .

[Analyst]: Great. Can you hear me okay?

Speaker #7: We can . Ryan .

Joe Gilliam: We can, Ryan. Okay, good.

Speaker #10: Okay , good . Yeah . Choppy earlier , but so maybe for for you , Joe a little bit on Idose , you know , in the absence of the CCaC meeting and , you know , kind of the , you know , permutations that could come out of that , I'm wondering if you could talk a little bit about how you think about the ramp of Idose .

[Analyst]: Yeah, maybe for you, Joe, a little bit on iDose in the absence of the CAC meeting and kind of the permutations that could come out of that. I'm wondering if you could talk a little bit about how you think about the ramp of iDose, and I ask that kind of in the context of 2026. Do we think of iDose following the similar progression in kind of a linear fashion through 2026 and beyond? Is there a point at which you see an inflection occurring where kind of the scales tip, if you will? I'm wondering if you could kind of speak to that and how you guys think internally about the progression and adoption of iDose over time.

Speaker #10: And , and I asked that I , you know , kind of in the context of 2026 and , you know , do we think of idose following the similar progression in , in kind of a linear fashion , you know , through 2026 and beyond ?

Speaker #10: Is there a point at which you see an inflection occurring where kind of , you know , the scales tip , if you will ?

Speaker #10: I'm wondering if you could kind of speak to that and kind of how you guys think internally about the progression and adoption of Idose over time .

Speaker #7: Yeah . Ryan , I think that the world we live in is , is obviously multi-dimensional relative to when we're building models or we're or we're trying to do this and there's a lot of , varying puts and takes when you think about that .

Joe Gilliam: Yeah, Ryan, I think that the world we live in is obviously multidimensional relative to when we're building models or we're trying to do this. There's a lot of varying puts and takes when you think about that. What we've clearly established is plus or minus a pretty solid linear type launch in its early days. I think it's hard to assess that without looking at the constituent parts of that. As you said in the context of 2026, we sit here today having put up $40 million of revenue in the third quarter with, as I said earlier, 80% of that volume coming from the Medicare regions that represent about 50% of covered lives.

Speaker #7: But what we've clearly established is , you know , plus or minus a pretty solid , you know , linear type launch in its early days , I think it's hard to assess that without looking at the constituent parts of that .

Speaker #7: Right . And as you said , in the context of 2026 , we sit here today having put up $40 million of revenue in the third quarter with , as I said earlier , 80% of that volume coming from the Medicare regions that represent about 50% of covered lives .

Speaker #7: So I think as we go forward , the Cap meeting all the other education efforts that we're doing with these individual Max , those establish proper and appropriate fee coverage , moving forward , that simply getting the Medicare arena to the right place alone continues to leave us optimistic around what that means for 2026 .

Joe Gilliam: I think as we go forward, the CAC meeting, all the other education efforts that we're doing with these individual MACs to establish proper and appropriate fee coverage moving forward, simply getting the Medicare arena to the right place alone continues to leave us optimistic around what that means for 2026 and certainly beyond. That's before, and I think you're touching on it a little bit, you start to think about that broader utilization that we're starting to see in some accounts across all patients who deserve to get access to iDose, irrespective of what insurance type they have, whether that's commercial, whether that's Medicare Advantage or certainly Medicare fee for service or other areas.

Speaker #7: And certainly beyond . And that's before . And I think you're touching on it a little bit . You start to think about that broader utilization that we're starting to see in some accounts across all patients who deserve to get access to Idose , irrespective of what insurance type they have , whether that's commercial , whether that's Medicare Advantage or certainly Medicare fee for service or other areas .

Speaker #7: So as we make our way through and more and more folks get focused simply on treating the disease , unless on the insurance type , I think that's when they're able to start focusing on really driving meaningful awareness in the standard of care .

Joe Gilliam: As we make our way through and more and more folks get focused simply on treating the disease and less on the insurance type, I think that's when they're able to start focusing on really driving meaningful awareness in the standard of care shift that we think iDose represents for these patients' benefit. Until you get to that place where you got a little bit more stability, if you will, around that water, call it market access landscape, it's hard for physicians to really focus holistically on the clinical care continuum. Once you get there, I don't want to say, you know, it'll be an inflection, but I think it's what underpins our bullish optimism of what iDose will mean for Glaukos, for our customers and for our patients, not just for 2026, but for the next decade, as we continue to change the standard of care.

Speaker #7: Shift that we think Idose represents for these patients . Benefit . But until you get to that place where you've got a little bit more stability , if you will , around that broader market access landscape , it's hard for physicians to really focus holistically on the clinical care continuum , but once you get there .

Speaker #7: I don't want to say , you know , it'll be an inflection , but I think it's what underpins our our bullish optimism of what idose will mean for glaukos , for our customers and for our patients , not just for 2026 , but for the next decade as we continue to change the standard of care .

Speaker #10: Okay , just related to the meeting , you know , the agenda was posted , the questions were posted a couple days ago .

[Analyst]: Okay, just related to the CAC meeting, the agenda was posted. The questions were posted a couple days ago. I don't want to leave the witness here, Joe, and I don't know if you're going to comment to this, but I'm going to try anyway. The questions kind of infer that the studies weren't long enough. I don't know if you have a reaction to that. You kind of articulated this earlier, but is that your sense that you're going to be educating them on the robust kind of evidence, the totality of the data and that there is a misalignment in terms of understanding, or do you feel like it's purely this is coming in with maybe a little more purpose, given how fast this has kind of bubbled up, if you will, relative to the historical efforts we've seen in legacy MIGS?

Speaker #10: I don't want to lead the witness here . Joe . And I don't know if you're going to comment to this , but I'm going to try anyway .

Speaker #10: And , you know , the questions kind of infer that the studies weren't long enough . And I don't know if you have a reaction to that .

Speaker #10: You kind of articulated this earlier , but is that your sense that you're going to be educating them on the robust , you know , kind of evidence that the totality of the data and , and that there is a misalignment in terms of understanding , or do you feel like , you know , purely , you know , this is coming in with maybe a little more purpose given how fast this is kind of , you know , bubbled up , if you will , relative to the historical efforts we've seen in legacy MiGs .

Speaker #10: I'm just , you know , I'm trying to still understand kind of why this has happened as quickly as it did . You know .

[Analyst]: I'm just trying to still understand kind of why this has happened as quickly as it did, so early in the launch cycle of iDose.

Speaker #10: So early in the launch cycle of iDose.

Speaker #7: Yeah , I think part of what you're talking about in answer to the latter is , is that , you know , we've also been trying to aggressively , you educate and advocate on behalf of our customers .

Joe Gilliam: Yeah, I think part of what you're talking about in answer to the latter is that we've also been trying to aggressively educate and advocate on behalf of our customers. I think if you take a step back, Ryan, and you think about how much enthusiasm there is in the clinical community around iDose and what it means for their patients and the outcomes they're seeing, all the things that have led to the optimism that extends from that for you all in the investment community, that also leads to those physicians advocating to make sure that they're getting properly paid and the coverage associated with it.

Speaker #7: I think , you know , if you take a step back , Ryan , you think about how much enthusiasm there is in the clinical community around Idose and what it means for their patients and the outcomes they're seeing .

Speaker #7: All the things that have led to the optimism that extends from that for for you all in the investment community , that also leads to to those physicians advocating to make sure that they're getting properly paid and the coverage associated with it .

Speaker #7: And I think a combination of that is probably what has led them to ask the questions of the broader advisory committee to make sure they understand.

Joe Gilliam: I think a combination of that is probably what has led them to want to ask the questions of the broader advisory committee to make sure they understand anytime you go into one of those sessions, there's going to be questions within that that make sense in the context of the way we or our physician customers look at this and other questions that do not. I think this preliminary question list reflects exactly that. There are some in there that you can understand, where they're trying to understand the overall fit of iDose into the treatment paradigm. They want to ask that question of a group of network of experts, if you will. There are others in there that clearly show they have not yet quite understood both the data, of which there's a lot. I don't hold that against anyone.

Speaker #7: Anytime you go into one of those sessions, there are going to be questions within that that make sense in the context of the way we or our physician customers look at this, and other questions that do not.

Speaker #7: And I think this preliminary question list reflects exactly that . There are some in there that you can understand . You know , that there where they're trying to , to to understand the overall fit of idose into the treatment paradigm .

Speaker #7: And they want to ask that question of , of , of a group of , of a network of experts , if you will .

Speaker #7: But there are others in there that clearly show that they have not yet quite understood both the data , of which there's a lot .

Speaker #7: And so I don't I don't hold that against anyone . That's a , that's an education process that take place here in the coming weeks , months if not years , as we continue to try to streamline that broader reimbursement coverage .

Joe Gilliam: That's an education process that has to take place here in the coming weeks, months, if not years, as we continue to try to streamline that broader reimbursement coverage.

Speaker #10: Thank you .

[Analyst]: Thank you.

Speaker #3: Your next question comes from Alan Gong from JP Morgan. Your line is open.

Chris Lewis: Your next question comes from Allen Gong from JPMorgan. Your line is open. Thanks for the question. Just as a quick follow-up to that, one question I do have is, you know, you obviously won't get an LCD immediately after the CAC meeting, but should you get an LCD, what does that do to, you know, your coverage with the MACs that are currently holding out and the MACs that you're already working with? Will that change, like your relationship with the MACs that don't have you on the Pro Fee schedule yet? Will that accelerate that process or will you still have to wait to get on Pro Fee?

Speaker #11: Thanks for the question . Just as a quick follow up to that one question , I do have is , you know , you obviously won't get an LCD immediately after the CEC meeting , but should you get an What does that do to , your coverage with the Macs that are currently holding out and the Macs that you're already working with , will that change your relationship with the Macs that don't have you on the schedule yet ?

Speaker #11: Will then accelerate that process ? Or will you still have to wait to get on ?

Speaker #7: Well , I think coverage and payment are two different things . And so from the standpoint that they attempt to appropriately value the procedural component associated with , with Idose , that process continues ongoing , we continue to have constructive dialogue with , with each of the three remaining Macs around that .

Joe Gilliam: I think coverage and payment are two different things. From the standpoint that they attempt to appropriately value the procedural component associated with iDose, that process continues, ongoing. We continue to have constructive dialogue with each of the three remaining MACs around that. Clearly now we have within GS being added 70% of Medicare lives with established professional fees and a whole lot of work that's gone in behind that to understand how to value that in price. I think that process continues to unfold. What you're talking about in the country, the way you asked it with LCDs and the like, is much more around coverage determinations. On that, I would just say that there are clearly scenarios that are positive for us, scenarios that present headwinds or areas where we have to educate them more fulsomely.

Speaker #7: Clearly, now we have, with Ings being added, 70% of Medicare lives with established professional fees and a whole lot of work that's gone in behind that.

Speaker #7: To understand how to value that and price . So I think that process continues to unfold with you're talking about in the country the way you asked it with LCDs and the like , is much more around coverage determinations .

Speaker #7: And on that , I would just say that , you know , there are there are clearly scenarios that are positive for us , scenarios that present headwinds or areas where we have to educate them Fulsomely .

Speaker #7: But going into it , we don't have a bias either direction in that regard . We're just focused on on making sure that we're educating them properly and that that they understand what they're looking at in terms of idose , the one clear positive , I'll say in any LCD that gets established is that alongside of that comes Medicare Advantage coverage policies as well .

Joe Gilliam: Going into it, we don't have a bias either direction in that regard. We're just focused on making sure that we're educating them properly and that they understand what they're looking at in terms of iDose. The one clear positive I'll say in any LCD that gets established is that alongside of that comes Medicare Advantage coverage policies as well. You do have to oftentimes, I'll call it commercial carriers that are behind Medicare Advantage policies, they will wait until formal LCDs are established to force them into having policies of their own. You can argue that there's certainly some opportunity associated with that. Should LCD ultimately emerge from this line of work?

Speaker #7: And so you do have to , you know , oftentimes the I'll call it commercial carriers that are behind Medicare Advantage policies . They will wait until formal LCDs are established to force them into having their own .

Speaker #7: And so you can argue that that there's certainly some opportunity associated with that should LCD ultimately emerge from from this of work .

Speaker #3: Your next question comes from the line of David Roman from Goldman Sachs . Your line is open .

Chris Lewis: Your next question comes from the line of David Roman from Goldman Sachs. Your line is open.

Speaker #12: Thank you . Good afternoon everyone . I want to just to come back to the market development and education efforts around a lot of what you're laying out .

[Analyst]: Thank you. Good afternoon, everyone. I wanted just to come back to the market development and education efforts around Epioxa. A lot of what you're laying out sounds like it actually more mirrors that of a more mass market disease and something that takes a lot of education. I don't know if it's direct to consumer as I look across other sort of rare disease categories and I'm thinking more on the traditional pharmaceutical and biotech categories. There is a lot of investment around payer education and physician education, but maybe you could help just give a little bit more flavor of some of the specifics around the investments that you're making and how we see those show up and over what time period.

Speaker #12: Sounds like it actually more mirrors that of of a more mass market disease . And something that takes a lot of education . I don't know if it's direct to consumer .

Speaker #12: As I look across other sort of rare disease categories , and I'm more in the traditional pharmaceutical and biotech categories , there is a lot of investment around payer education and physician education , but maybe you could help just give a little bit more flavor of some of the specifics around the investments that investments that you're making and , and how we see those show up and over what time period .

Speaker #7: Yeah , David , it's Joe . So I think counter to a little bit , I'll start macro and then little more micro for your question .

Speaker #7: Yeah , David , it's Joe . So I think counter to a little bit , I'll start macro and then I'll get a terms of large population based .

Joe Gilliam: Yeah, David, it's Joe. I think counter to a little bit, I'll start macro and then I'll get a little more micro for your question. From a macro perspective, what you think of in terms of large population-based patient education initiatives are the legacy, I'll call it direct patient advertising commercials that you see on broadband television during various sporting events or whatever it may be that is there to help make sure there's awareness being driven. What's different with rare disease is it's much more of a needle in a haystack exercise. That effort, those efforts around awareness and detection mirror that of that broader disease state or mass market, as you said, but they're done in a much more targeted way to make sure that you're trying to find those patients who are most applicable based on where they're at in their own disease journey.

Speaker #7: Patient education initiatives are the legacy. I'll call it direct patient advertising commercials that you see on broadband television during various sporting events or whatever it may be. This is there to help make sure there's awareness being driven.

Speaker #7: What's different with rare Disease is it's much more of a needle in a haystack exercise . And so that effort , those efforts around awareness and detection mirror that of that , that broader disease state or mass market , as you said .

Speaker #7: But they're done in a much more targeted way to make sure that you're trying to find those patients who are most applicable based on where they're at in their own disease journey.

Speaker #7: And so a that happens in , in different forums and different communities that are more digital in nature , where folks are actively seeking out what's causing the change in their vision .

Joe Gilliam: A lot more of that happens in different forums and different communities that are more digital in nature, where folks are actively seeking out what's causing the change in their vision. It's important to take a step back here and remember that you heard Tom say this, but when only 13% of patients are being treated under the age of 18, and we know the vast majority of damage is happening or certainly starting to happen and accelerating in the teenage years and into the 20s, and yet the vast majority of patients aren't getting access at that stage.

Speaker #7: You know , it's important to take a step back here and remember that you heard Tom say this , but when only 13% of patients are being treated under the age of 18 , and we know the vast majority of damage is happening , or certainly starting to happen in accelerating in the teenage years and into the 20s .

Speaker #7: And yet , the vast majority of patients aren't getting access at that stage . You really have to redouble your efforts to find them much earlier in that journey , based upon those early symptoms and the early things that could be signs of keratoconus , to make sure that they're getting proper access to the detection and the various things that are necessary to at least diagnose them as a keratoconus suspect .

Joe Gilliam: You really have to redouble your efforts to find them much earlier in that journey based upon those early symptoms and the early things that could be signs of keratoconus to make sure that they're getting proper access to the detection and the various things that are necessary to at least diagnose them as a keratoconus suspect. That's a really big investment from a commercial and marketing standpoint. It's not just DTC, although that's obviously an important part of any education thing. There's a lot in terms of what you do with your field organizations. Just to put that in context, a little more micro level. David, today the majority, or if not all of the treating physicians for Photrexa are in the MD community. You're very much reliant upon the optometric community where these patients first present themselves most often with visual acuity issues.

Speaker #7: And that's that's a really big investment from a commercial and marketing standpoint . And it's not just DTC , although that's obviously an important part of any education thing .

Speaker #7: There's a lot in terms of what you do with your field organizations . And just to put that in context , a little more micro level , David , you know , today the majority or if not all of the treating physicians for Photrexa are in the MD community .

Speaker #7: But you're very much reliant upon the optometric community, where these patients first present themselves most often with visual acuity issues. There are 50,000 optometrists and numerous other optometry opticians that serve a little bit as the primary care physician.

Joe Gilliam: There are 50,000 optometrists and numerous other opticians that serve a little bit as a primary care physician. How you get to driving education awareness in that community, both visually as well as with your salesforce and other marketing related activities, is a pretty significant investment. That part of it is really just the beginning in terms of driving awareness and education, if you will. You also have to then support, and anytime you have a needle in a haystack patient. Again, you heard Tom reference the prepared remarks. These patients, think about the number of insurance plans that are out there.

Speaker #7: So how you get to driving education and where that community , both digitally as well as with your sales and other marketing related activities , is a pretty significant investment .

Speaker #7: Now that part of it is really just the beginning in terms of driving awareness and education , if you will . You also have to then support , and anytime you have a needle in a haystack patient and again , you heard Tom references in the prepared remarks .

Speaker #7: But these patients think about the number of insurance plans that are out there . And when you're only treating 10,000 patients every single time , one of those patients presents themselves at for , you know , access to photrexa .

Joe Gilliam: When you're only treating 10,000 patients, every single time one of those patients presents themselves asking for access to Photrexa, not the oxa, it's like this is the first time that that insurer has ever seen a claim because you're talking about 10,000 patients. There are 5,000 plans in the U.S. To that point of really making sure you demystify the insurance process, that you support them along that way with proper education as you go through that, and ultimately, to the extent qualified, provide them with assistance as they go through, are all major, major investments for us. The last thing you have to think is how that turns on. We're going to have, and Alex can comment on this in the context of the broader FT and L, we're going to have some of this happen right away.

Speaker #7: Now, it's like this: the first time that that insurer has ever seen a claim because you're talking about 10,000 patients. There are 5,000 plans in the United States.

Speaker #7: So to that point of really making sure you demystify the insurance process , that you support them along that way with proper education , as you go through that and ultimately to the to the extent qualified , provide them with assistance as they through .

Speaker #7: Are all major , major investments for us . Now , the last thing you asked , I think , is how that turns on .

Speaker #7: We're going to have and Alex can comment on this in the context of the broader PNL . We're going to have some of this happens right away .

Speaker #7: Some of that certainly picks up steam as we make our way into 2026 . At the beginning . And then start to get the J-code established and our site of care network up and in the second half , we'll try to elevate that up to , I'll call it a full scale effort supporting those patients in that process .

Joe Gilliam: Some of it certainly picks up steam as we make our way into 2026 in the beginning, and then as we start to get the J Code established and our site of care network up and running, the second half, we'll try to elevate that up to, I'll call it a full scale effort, supporting those patients in that process and their journey as we make our way and certainly as we exit 2026 into 2027.

Speaker #7: as we

Speaker #7: And and their journey as we make our way . And certainly as we exit 26 into 27 .

Speaker #12: Great . I'll leave it there . Thank you .

[Analyst]: Great. I'll leave it there. Thank you.

Chris Lewis: Your next question comes from the line of Richard Newitter from Truist Securities. Your line is open.

Speaker #3: question comes from the line of Richard Newitter from Truist . Your line is open .

Speaker #13: Hi . Excuse me . Thanks for taking the questions . I might have missed it , but I just want to make sure I'm understanding the components of your updated 25 guidance and kind of how we should be thinking about the areas for for Q and what's implied there .

Joe Gilliam: All right. Excuse me. Thanks for taking the question. I might have missed it, but I just want to make sure I'm understanding the components of your updated 2025 guidance and kind of how we should be thinking about the areas for Q4 and what's implied there. Can you just run through the segments? I know you provided a prior outlook for Corneal Health and I think it was flat to low single digit growth for the year. Could you just give us a sense as to what we should be modeling for that business and what the trend should be in the kind of the Epioxa sequential trend? Yeah, Richard, happy to do it. I haven't addressed it yet obviously, other than us announcing the updated guidance range of $490 to $495 million. Yeah.

Speaker #13: Can you just run through the segments ? I know you provided prior outlook for corneal health and it I think it was flat to low single digit growth for the year .

Speaker #13: Could you just give us a sense as to what we should be modeling for that business ? And what the trend should be in , in the , in the kind of the , the idose sequential trend ?

Speaker #7: Yeah . Richard . Happy to do it . I haven't addressed it yet , obviously , other than us announcing the updated guidance range of 490 to 295 million .

Speaker #7: You know , I think first , putting it in context , the performance thus far in 2025 and and obviously highlighted with the results in the third quarter has really continued to exceed our our internal forecast .

Joe Gilliam: I think first putting in context the performance thus far in 2025 and obviously highlighted with the results in the third quarter has really continued to exceed our internal forecast and based upon that we did raise our expectations for the year. The biggest thing here in the fourth quarter is not new. We called it out on the last call and that is to take into consideration the expected headwinds that may face our Corneal Health franchise in the fourth quarter as we and, you know, more importantly our patients and customers prepare for the transition from Photrexa to Epioxa. Secondarily, I would say that the fourth quarter is a little bit more of an elevated or more difficult comp from a year over year growth perspective in our U.S. and international glaucoma franchises.

Speaker #7: And and and based upon that , we did raise our expectations for the year . The biggest thing here in the fourth quarter is not new .

Speaker #7: We called it out on the last call that it is to take into consideration the expected headwinds that may face our corneal health franchise in the fourth quarter.

Speaker #7: As we and , you know , more importantly , our patients and customers prepare for the transition from Photrexa to epi oxa . Secondarily , I would say that the fourth quarter is a little bit more of an elevated or more difficult comp from a year over year growth perspective in our US and international glaucoma franchises .

Speaker #7: As you're thinking about kind of looking at dialing that in relative to where we've been in the last couple of quarters , as you think about the individual franchises , within that , I would say that for international glaucoma , the dynamics here really remain unchanged from what we've talked about previously .

Joe Gilliam: As you're thinking about kind of looking at dialing that in relative to where we've been in the last couple of quarters as you think about the individual franchises within that, I would say that for international glaucoma the dynamics here really remain unchanged from what we've talked about previously. We expect low double digit growth in the fourth quarter based upon that slightly tougher comp that I mentioned and really combining that with the continued sort of competitive launch headwinds that exist in several key markets. Nothing new there. On the Corneal Health side, I referenced it, I think a little bit of it. You'll back into the expectations there. We do expect to see a fairly material year over year decline and that's certainly implied in the guidance as we navigate that transition that I mentioned before.

Speaker #7: We expect low double-digit growth in the fourth quarter based on that slightly tougher comp that I mentioned. And really, combining that with the continued sort of competitive launch headwinds that exist in several key markets.

Speaker #7: So nothing new there on the corneal health side , I referenced , I think a little bit of it . You'll , you'll , you'll back into the expectations there .

Speaker #7: We do expect to see a fairly material year over year decline , and that's implied in the guidance as we navigate that transition that I mentioned before .

Speaker #7: And and we've already started to see some early signs of that emerge even here in October post the approval of epi Oxa . And we've even seen patients now starting to come and ask about epi oxa in favor of the existing photrexa therapy that may be offered to them on the US glaucoma side .

Joe Gilliam: We've already started to see some early signs of that emerge even here in October post the approval of Epioxa, and we've even seen patients now starting to come and ask about Epioxa in favor of the existing Photrexa therapy that may be offered to them. On the U.S. glaucoma side, we expect growth in the mid 40% range year over year in the fourth quarter as our non-iDose business continues its stents and everything else continues to stabilize. We would expect a low single digit decline in the fourth quarter.

Speaker #7: We expect growth in the mid 40% range year over year . In the fourth quarter , as our non idose business continues to stents and everything else continues to stabilize , we would expect in low single digit decline in the fourth quarter .

Speaker #7: So continue on that that progress back to I'll call it a more stabilized situation . Post the the LCDs that have impacted it .

Joe Gilliam: Continue on that progress back to a more stabilized situation post the LCDs that have impacted that part of the business earlier in the year, and we do expect continued growth obviously in iDose TR, although you may find implied in the guidance it's tempered a little bit sequentially versus the current trends just given many surgeons have pretty full cataract schedules throughout the remainder of the year. I think it's a little bit early to start seeing the benefit from the NGS, call it professional fee tailwind, and again in general this quarter is a bit of a tougher year over year comp from a growth standpoint. I think what you'll find is that it continues to be largely all systems go across the majority of our business with the one step back being really in the Corneal Health franchise as we transition there. Okay, thanks.

Speaker #7: That part of the business earlier in the year . And we do expect continued growth . Obviously in Idose TR although you may find implied in the guidance , it's tempered a little bit sequentially versus the current trends just given many , many surgeons have pretty full cataract schedules throughout the remainder of the year .

Speaker #7: I think it's a little bit early to start seeing the benefit from from the NGS . I'll call it professional field professional fee tailwind and again , in general , this quarter is a bit of a tougher year over year comp from a growth standpoint , but I think what you'll you'll find is that it continues to be largely all systems go across the majority of our business with the one step back being really in the corneal health franchise .

Speaker #7: As we transition , there .

Speaker #13: Okay , thanks . And then maybe just a actually two follow ups consensus for for idose for 26 is somewhere in the 220 to 225 million range .

Joe Gilliam: Maybe just actually two follow ups. Consensus for iDose for 2026 is somewhere in the $220 million to $225 million range. I think anything you can express in terms of comfort or not kind of there just so we can benchmark ourselves as we put preliminary numbers out there. Second follow up just on the trial timelines that you were talking about for combo cataract and MIGS plus iDose. Can you just give us a sense as to when those that are going to read out and the ones that have read out where they are? I'll start and then I'll let Tom comment on the trials associated with iDose continue to be ongoing. Really, Richard, as I mentioned earlier, I think we're going to stay with the broader guidance that we've given for next year of $600 million to $620 million.

Speaker #13: I think can , you know anything you can express in terms of comfort or not kind of kind of there , just so we can benchmark ourselves as we put preliminary numbers out there and then second follow up , just on the trial timelines that you were talking about for combo , cataract and MiGs , plus , can you just give us a sense as to when those those that are going to read out and the ones that have read out where they are .

Speaker #7: So I'll start and then I'll let Tom comment on the the trials associated with dose and continue to be ongoing . You know , really , Richard , as I mentioned earlier , I think we're going to we're going to stay with the broader guidance that we've given for next year of 606 .

Speaker #7: 20 . We'll talk a bit more on the constituent parts of that on the fourth quarter call . You know , you referenced the consensus in Idose .

Joe Gilliam: We'll talk a bit more on the constituent parts of that on the fourth quarter call. You know you referenced the consensus and iDose. Clearly as we enter into next year, iDose is no longer the only, I'll call it material variable that you all will be focused on and assessing. I want to make sure that we talk about that in the same context and same time as we talk about our expectations for Epioxa and the Corneal franchise throughout the year. What I had said based on the earlier question was if you think about the third quarter results of $40 million, we're at this point already kind of on a $160 million run rate based again largely on the continued progress within the three MACs that have established professional fee coverages entering the quarter, that being Novitas, Noridian, and First Coast.

Speaker #7: Clearly , as we enter into next year , Eidos is no longer the only , I'll call it , material variable that that you all will be focused on and assessing .

Speaker #7: And so I want to make sure that we talk about that in the same context and same timing as we talk about our expectations for , Fox and the corneal franchise throughout the year .

Speaker #7: You know what I , what I had said , based on the earlier question , was , if you think about the third quarter results of 40 million , we're at this point already kind of on $160 million run rate based again , largely on the continued progress within the three Macs that have established professional fee coverages entering the quarter .

Speaker #7: That being Novitas and and First Coast . So I feel good about the momentum in that part of the business and where it's heading and what that 2026 , but we'll get more granular on the exact numbers as we set or update our guidance for the for the full year .

Joe Gilliam: I feel good about the momentum in that part of business and where it's heading and what that'll mean for 2026. We'll get more granular on the exact numbers, as we said, or update our guidance for the full year when we get on the fourth quarter call. Tom?

Speaker #7: When we get on the fourth quarter call .

Speaker #5: Yeah , I'd be happy to answer the questions . We're looking at two pretty major level one phase four clinical studies . And that's a look at Idose plus cataract versus cataract surgery alone , which we're currently enrolling .

Thomas Burns: Yeah, I'd be happy to answer the questions. We're looking at two pretty major level one baseboard clinical studies, and that's a look at iDose TR plus cataract versus cataract surgery alone, which we're currently enrolling. We're also looking at a study that evaluates iDose TR plus iStent infinite versus iStent infinite alone. You can imagine the goals of both those studies will be to validate and to show the incremental advantage of using iDose TR in combination with cataract surgery, and certainly iDose TR in combination with iStent infinite versus iStent infinite alone. These are important studies as we go forward, and really they're both currently under enrollment. It really will depend on when we choose to be able to show what length of data we want to show.

Speaker #5: And as well, we're looking at a study that evaluates Idose plus Infinite versus Infinite alone. You can imagine the goals of both those studies will be to validate and to show the incremental advantage of high dose in combination with cataract surgery.

Speaker #5: And certainly high incombination with infinite versus infinite alone . So these are important studies as we go forward . And really they're both currently under enrollment .

Speaker #5: It really will depend on when we choose to be able to show what length of data we want to show . And so I would probably prepare the investment community for a 2027 timeline , which would give us the ability to have really six months to a year of follow up in each of these patients that we publish .

Thomas Burns: I would probably prepare the investment community for a 2027 timeline, which would give us the ability to have really six months to a year of follow-up in each of these patients that we publish. It may come as early as late 2026 if we choose to be able to terminate the study, or I should say be able to look at these patients at earlier time points. Typically, three months would be the earliest that I'd be able to publish. I'd set your parameters to look at a late 2026-2027 with some very, very important follow-up clinical data for the use of iDose TR.

Speaker #5: And it may come as early as late 2026 if we choose to be able to determine the study or or I should say , be able to look at these patients at earlier time points , typically three months would be the earliest that I'd be able to publish .

Speaker #5: So I've set your parameters to look at a late 20s, 26 to 27, with some very, very important follow-up clinical data for the use of high dose.

Speaker #3: Due to time allotted for the question and answer session , we please ask you to limit yourself to one question . Thank you .

Chris Lewis: Due to time allotted for the question and answer session, we please ask you to limit yourself to one question. Thank you. Your next question comes from the line of Mason Carrico from Stephens. Your line is open.

Speaker #3: Your next question comes from the line of Mason Carrico from Stephens . Your line is open .

Speaker #14: Hey guys , thanks for fitting me in here . So in the context of epi pricing , could you just remind us how the bulk of Photrexa volumes are billed today ?

Joe Gilliam: Hey guys, thanks for fitting me in here. In the context of Epioxa pricing, could you just remind us how the bulk of Photrexa volumes are billed today? You guys utilize a buy and bill strategy with clinics and if so, how much of your volumes rely on that? Yeah, Mason, with Photrexa today, we offer both buy and bill acquisition options as well as specialty pharmacy. The specialty pharmacy option is something that we've really brought online primarily over the last couple of years and that's been a growing percentage of the overall mix. Beyond that, I'm not prepared to disclose the exact mix between those, but I will say that specialty pharmacy has become an increasing material portion of the overall acquisition mix.

Speaker #14: You . Guys utilize a book and bill strategy with clinics , and if so much of your volume rely on that ?

Speaker #7: Yeah . Mason , with today we offer both BI and Bill acquisition options as well as specialty pharmacy . The specialty pharmacy option is something that we've really brought online primarily over the last couple of years , and that's been a growing percentage of the overall mix .

Speaker #7: But but beyond that , I'm not prepared to disclose . You know , the exact mix between those . But I will say that

Speaker #7: specialty pharmacy has become , how an increasingly material portion of the overall acquisition mix .

Speaker #3: Your next question comes from the line of David Saxon from Needham and Co . Your line is open .

Chris Lewis: Your next question comes on the line of David Saxon from Needham and Company. Your line is open.

Speaker #15: Great . Yeah . Thanks , guys . Thanks for fitting me in . Yeah , just another one on Epyaxa . So can you just talk about the cadence of getting coverage by commercial payers in 2026 ?

[Analyst]: Great. Yeah, thanks guys. Thanks for sending me in. Yeah, just another one on Epioxa. Can you just talk about the cadence of getting coverage by commercial payment payers in 2026? I mean if Photrexa will be phased out next year, how much coverage do you think you can end the year with 2026 with, and then in terms of, you know, placing the new cross-linking machines for Epioxa, what's the strategy there for either upgrading or trading out the current installed base? Thanks so much.

Speaker #15: I mean , if Photrexa will be phased out next year , how much coverage do you think you can end the year with 2026 , with .

Speaker #15: And then in terms of , you know , placing the new cross-linking machines for Epyaxa kind of what's the strategy there for either upgrading or trading out the current installed base ?

Speaker #15: Thanks so much .

Speaker #7: Yeah , David , I'll start with on the , you know , capital and and establishing the site of care network Epyaxa does require a new piece of capital equipment and O2 system that will be made equipment .

Joe Gilliam: Yeah, David, I'll start with on the capital equipment and in establishing the site of care network, Epioxa does require a new piece of capital equipment, an O2N system that will be made available. We are already now with the approval in hand, hard at work out with customers to establish that changeover. As you might expect on a launch of this nature, we've got a variety of options for customers to acquire, to lease, and to swap out their existing equipment to make sure that the capital equipment component of this is not an impediment to them getting into providing Epioxa as a therapeutic solution.

Speaker #7: We are already now with the approval in hand , hard at work out in the with customers to establish that changeover . As you might expect in a launch of this nature , we've got a variety of options for customers to acquire to lease and to available swap out their existing equipment to make sure that the capital equipment component , this is not an impediment to them getting into providing epyaxa as a therapeutic solution for the payer coverage side .

Joe Gilliam: For the payer coverage side, you may recall on prior calls that we've been investing pretty heavily in this part of our organization alongside our field-based reimbursement, and that team is already hard at work similar to establishing our site of care, but in this case with the payers around direct education efforts, meetings that make sure they understand what we've just disclosed here today in terms of the therapy, its benefit to patients, engaging with those in the medical community to make sure that they're educated around that and ultimately trying to establish that coverage. I think on the positive side, this is not the first launch in the category and many payers already recognize that corneal cross-linking is the standard of care when it comes to arresting the progression of this sight-threatening disease.

Speaker #7: You may recall on prior calls that we've been investing pretty heavily in this part of our organization alongside our field based reimbursement and and that team is already hard at work , similar to to establishing our site of care .

Speaker #7: But in this case with the payers around direct education efforts , meetings to make sure they understand what we've just disclosed here today in terms of the therapy , its benefit to patients engaging with those in the medical community to make sure that they're educated around that and ultimately trying to establish that coverage .

Speaker #7: I think on the positive side , this is not a the first launch in the category , and many payers already recognize that corneal crosslinking is the standard of care when it comes to arresting the progression of this sight , threatening disease .

Speaker #7: And standpoint , we need to educate them that on the patient benefits of which there are many . As you heard , Tom mention them during his remarks as to the why behind the patient need to achieve access to Fox going forward .

Joe Gilliam: From that standpoint, we need to educate them then on the patient benefits, of which there are many. You heard Tom mention them during his remarks as to the why behind the patient need to achieve access to Epioxa going forward. That process is already well underway. We'll provide updates as we make our way throughout the year. It's a little bit premature for us to establish benchmarks in terms of payer coverage expectations. I'm optimistic that when we engage in the conversation around the benefits that we're providing to the patients that are at the end of this, that will move the needle as aggressive as we can with those payers to get that access going throughout the course of 2026.

Speaker #7: So that process is already well underway . You know , we'll provide updates as we make our way throughout the year , but it's a little bit premature for us to to establish benchmarks in terms of payer coverage expectations .

Speaker #7: I'm optimistic that when we engage in the conversation around the benefits that we're providing to the patients that are at the end of this , that will that will , that will move the needle as aggressive as we can with those payers to get get that access going throughout the course of 2026 .

Speaker #3: Your next question comes from the line of Joanne Wunsch from Citibank . Your line is open .

Chris Lewis: Your next question comes from the line of Joanne Wynch from Citibank. Line is open.

Speaker #16: Thank you so much . I have so many questions , but I'm I'm going to try and stick to my one , which is when you gave guidance 2026 .

Operator: Thank you so much. I have so many questions, but I'm going to try and stick to my one, which is when you gave guidance for 2026, what is included in that for Epioxa and what is included for that for iDose? I'm just trying to piece it all together because at that ASP, those numbers can ramp really fast.

Speaker #16: What is included in epi ? AXA . And what is included that for that , for Idose ? I'm just trying to piece it all together because at that ASP , those numbers can ramp really fast .

Speaker #7: Yeah . Thanks . Joanne . So as I mentioned before , I think we want to make sure that we were establishing an overall range for for 2026 .

Joe Gilliam: Yeah, thanks, Joanne. As I mentioned before, I think we wanted to make sure that we were establishing an overall range for 2026 in light of the Epioxa approval and announcement and the number of moving parts. For right now, I think I'll just leave it as what I said earlier that we're confident in that range and we're confident there's a variety of paths that should enable us to meet those expectations. We'll provide a lot more color on our fourth quarter call around the individual constituent parts of that. You raise a totally valid and somewhat obvious point in that with the wholesale acquisition cost and what that means in terms of, you know, relative to that implied in there is a material step down in the number of patients being treated with Epioxa in 2026.

Speaker #7: In light of , of of the approval and announcement and the number of moving parts . And for right now , I think I'll just leave it as what I said earlier that that we're confident in that range and we're confident there's a variety of paths that should enable us to meet those expectations .

Speaker #7: We'll provide a more color on our fourth quarter call around individual constituent parts of that , but you raise a totally valid and somewhat obvious point in that with the wholesale acquisition cost and what that means in terms of , you know , relative to that implied in there is a is a is a material step down in the number of patients being treated with in 2026 , as we navigate all the things that I've already mentioned , including getting the site of Care Network established , the miscellaneous code before establishing the J code , the time in which it takes to update the payers for that J code .

Joe Gilliam: As we navigate all the things that I've already mentioned, including getting the Cyticare network established, the miscellaneous code before establishing J code, the time in which it takes to update the payers for that J code in the second half, it'll be a journey through the year of really getting the foundation underneath us so that we can be focused primarily on clinical care as we exit the year and head into 2027.

Speaker #7: In the second half, it'll be a journey through the year of really getting the foundation underneath us so that we can be focused primarily on clinical care as we exit the year and head into 2027.

Speaker #3: Your next question comes from the line of Michael Sarcone with Jefferies. Your line is open.

Chris Lewis: Your next question comes from the line of Michael Sarcone with Jefferies. Your line is open.

Speaker #17: Hey, good afternoon, and thanks for squeezing me in. I was just going to try to ask the mixed case for Idose in a different way.

Joe Gilliam: Hey, good afternoon and thanks for squeezing me in. I was just going to try to ask the mixed case for iDose in a little different way. Joe, when you think about your internal modeling and what you're expecting for iDose, maybe over the next, you know, three years, call it the midterm range. How do you think about the mix of iDose performed in the standalone setting versus combo cataract? I think that's very surgeon specific. If you look even at the adoption we've had now, our highest volume customers today do actually very little iDose in combination with cataract surgery. Clearly, as you make the product available in that wider arena, the lower hanging fruit for some surgeons who primarily focus on cataract surgery is for them to be doing it in combination.

Speaker #17: Joe , when you think about your internal modeling and what you're expecting for for idose , maybe over the next three years , call it the mid-term range .

Speaker #17: How do you think about the mix of Idose performed in the standalone setting versus combo cataract ?

Speaker #7: think that's very surgeon specific . And if you look even at the adoption , we've had now , our highest volume customers today do actually very little idose in combination with cataract surgery .

Speaker #7: Clearly , as you make the product available in that wider arena , the lower hanging fruit for some surgeons who primarily focus on cataract surgery is for them to be doing it in combination .

Speaker #7: And so I think in the , in the , in the intermediate term , some of that quote unquote , lower hanging fruit for that , that portion of the community could drive the mix a little bit closer to or with a little bit more oriented towards the combo cataract setting , but certainly as you get out into the three , five and ten year time horizon , the vast , vast majority of it is interventional in nature and standalone being the key driver of our of our long term opportunity .

Joe Gilliam: I think in the intermediate term some of that quote unquote lower hanging fruit for that portion of the community could drive the mix a little bit closer to or live with a little bit more oriented towards the combo cataract setting. Certainly, as you get out into the 3, 5 and 10 year time horizon, the vast vast majority of it is interventional in nature and standalone being the key driver of our long term opportunity.

Speaker #3: Your next question comes from the line of Anthony Petrone from Mizuho Group .

Chris Lewis: Your next question comes from the line of Anthony Petrone from Mizuho. Thanks. Maybe one on the follow up discussion with FDA on iDose reapplications. You mentioned in the prepared comments and the materials for the third quarter that those discussions are still ongoing. What is the latest there and when do you expect FDA to make some sort of announcement on the supplement for iDose reapplications, and what is really the read through of that element of the iDose story as we head into the CAC meeting on November 12th? Thanks.

Speaker #18: Thanks . Maybe one on the follow up discussion with on Idose Reapplications . You mentioned in the prepared comments and the materials and for the third quarter that those discussions are still ongoing .

Speaker #18: So maybe just what is the latest there and when do you expect FDA to make , you know , some sort of announcement on the supplement for Eidos Reapplications ?

Speaker #18: And what is really the read through of that element of the Idose story , as we head into the meeting on November 12th .

Speaker #18: Thanks .

Speaker #5: Yeah, I'll be happy to take the first part of that question. So just to reiterate, the date has already been established by the FDA.

Thomas Burns: Yeah, I'll be happy to take the first part of that question. Just to reiterate, the PDUFA date has already been established by the FDA. It will be January 28, 2026, and we expect then to get an answer to our appeal to be able to have readministration of the iDose device. As I've said many, many times before, we take a belts and suspenders approach to this. The reason we have iDose TREX already in a clinical trial and moving forward is to have the ability for surgeons to have a de facto exchange product available when their current implementations of iDose come to term in three plus years. We think we're in great shape from that perspective. As I've said before, and I'll choose my words carefully here, we are hopeful but we're not counting on the FDA giving us the nod to move forward with readministration.

Speaker #5: It will be January 28th of this coming year , 2026 . And we expect then to get an answer to our appeal to be able to to have the Idose device .

Speaker #5: As I've said , many , many times before , we take a belt and suspenders approach to this . The reason we have high dose T-Rex already in a clinical trial and moving forward is to have the ability for surgeons to have a de facto exchange product available when their their current implantations of idose come to term in three plus years .

Speaker #5: And so we think we're in great shape from that perspective . As I've said before . And I'll choose my words carefully here we are .

Speaker #5: We are hopeful , but we're not counting the FDA giving us the nod to move forward with Readministration .

Speaker #7: And as it relates to the I think the second part of your question on the on the meeting and some of the considerations around there , it's actually , I think , an thoughtful question because it's important to think about Idose as an FDA approved pharmaceutical with a label and intended use .

Joe Gilliam: As it relates to, I think, your second part of your question on the CAC meeting and the considerations around there, it's actually, I think, a thoughtful question because it's important to think about iDose as an FDA-approved pharmaceutical with a label and intended use that's pretty similar to topical PGAs and other glaucoma medications. That's different than a medical device. I say that because what matters in an FDA-approved pharmaceutical is what the contraindications are that are with it. Currently, reimplantation is the primary contraindication for iDose TR. It's not whether it's utilized in combination with cataract surgery, other MIGS devices, or heart medication for that matter. Today, iDose TR is approved with an open label that's very similar to those topical PGAs.

Speaker #7: It's pretty similar to topical pgas and other glaucoma medications . That's different than a medical device . And I say that because what matters in FDA approved pharmaceutical is what is the contraindications that are within it .

Speaker #7: And the currently reimplantation is the primary contraindication for idose TR it's not whether it's utilized in combination with cataract surgery . Other MiGs devices or heart medication for that matter .

Speaker #7: Today , I-doser is approved with with an open label that's very similar to those topical pgas . If indeed , as Tom is talking about , we were to to achieve that , the date around reimplantation that would bring that to , to to remove or at least modify that contraindication and certainly help us in terms of opening up that part of the market .

Joe Gilliam: If indeed, as Tom is talking about, we were to achieve that, the PDUFA data around reimplantation, that would bring that to remove or at least modify that contraindication and certainly help us in terms of opening up that part of the market.

Speaker #18: Thank you .

Chris Lewis: Thank you. Your next question comes from the line of Danielle Antalffy from UBS. Your line is open.

Speaker #3: Your next question comes from the line of Danielle Antalffy from UBS . Your line is open .

Speaker #19: Hey , good afternoon guys . Thanks so much for taking the question . I was at the AAO meeting a few weeks ago , and I felt like the takeaway from my perspective , they're looking for specific things , right ?

Operator: Hey, good afternoon guys. Thanks so much for taking the question. I was at the AAO meeting a few weeks ago and I felt like the takeaway from there, they're looking for specific things, right. There was a focus on building out standalone MIGS practices. I attended a lunch session that was focused on that. I'm just curious about how you guys think the launch of iStent infinite into standalone is going. Where you see standalone as a percent. I'm not asking iDose, right. I'm asking for the total MIGS patient population here, where you see standalone MIGS going over the next three to five years. What are the sort of logistical things with practices that you think need to happen in order to enable continued growth in that market? Thanks so much.

Speaker #19: But was a focus on building out a , you standalone MiGs practices . I attended a lunch session that was focused on that , and I'm just I'm just curious about how you guys think the launch of Istent infinite into standalone is going where you see standalone as a percent .

Speaker #19: I'm not asking Idose , right . I'm asking for the total MiGs . You know , patient population here where you see standalone MiGs going over the next 3 to 5 years .

Speaker #19: And what are the sort of logistical things with practices that you think need to happen in order to enable continued growth in , in that market ?

Speaker #19: Thanks so much .

Speaker #7: Yes , Daniel , I think it's a great question . And a good one here as we are wrapping up this conversation . I mean , everything that we've been doing for a couple of years now , and certainly as we are moving forward , is around driving that standard of care towards interventional glaucoma and acting on behalf of these patients .

Joe Gilliam: Yes, I think it's a great question and a good one here as we are wrapping up this conversation. I mean, everything that we've been doing for a couple of years now and certainly as we are moving forward is around driving that standard of care towards interventional glaucoma and acting on behalf of these patients. From that standpoint, it doesn't surprise me, although I'm always happy to hear that as you were doing your checks and rounds at AAO, that you heard that same thing. Anytime you have a profound standard of care shift, there are logistical hurdles. The first one you have to get through is the clinical component of this and the clinical buy-in from the community.

Speaker #7: And so from that standpoint , it doesn't surprise me , although I'm always happy to hear that , as you were doing your checks and and rounds at , at AAO , that you heard that same thing .

Speaker #7: There's a anytime you have a profound standard of care shift , there are logistical hurdles , but the first one you have to get through is the clinical component of this .

Speaker #7: And the clinical buy in from the community . And you've heard us say this before , but I'll reiterate it . We couldn't be more happy with the receptivity from the physician community around the need to act on behalf of these patients in an interventional way , and whether that tool is idose , whether that tool is iced , an infinite , or any of the other things that might be a part of , of , of their toolkit , if you will , in trying to tackle this , this sight threatening disease .

Joe Gilliam: You've heard us say this before, but I'll reiterate it, we couldn't be more happy with the receptivity from the physician community around the need to act on behalf of these patients in an interventional way. Whether that tool is iDose, whether that tool is iStent infinite or any of the other things that might be a part of their toolkit, if you will, in trying to tackle this sight-threatening disease, it's encouraging to hear that they continue to sort of move forward. On the logistical side, it does change. It's changing the education of the optometry referral community. It's changing the scheduling blocks, it's changing the time and allocation of that time within their OR time, their surgery centers and the like. There's a lot that goes into this over time.

Speaker #7: It's encouraging to hear that they're that they continue to sort of move forward . But on the logistical side , it does change it change .

Speaker #7: It's changing the education of the optometry . Referral community . It's changing the scheduling blocks . It's changing the time and allocation of that time within their their , their , their or time , their surgery centers and the like .

Speaker #7: There's a lot that goes into this over time . It's about establishing proper reimbursement and market access for the various tools that are there to treat patients the way you want to treat them .

Joe Gilliam: It's about establishing proper reimbursement and market access for the various tools that are there to treat patients the way you want to treat them as a surgeon or physician. Each one of these things plays themselves out and none of them are overnight success stories. Each one of these things, you make incremental progress every day, every week, every month, and every year. I think it's why when we look out over a three, five or ten year period, we're so optimistic about where this is all heading, because it's all rooted in the right paradigm shift of clinical care. The rest of it, we have to keep our head down and keep executing against that. If we do that, you're talking about a market opportunity. As you've heard me say many times, there are 21 or 22 million eyes in the U.S. with ocular hypertension or glaucoma.

Speaker #7: As a surgeon or a physician . So each one of these things play themselves out , and none of them are overnight success stories .

Speaker #7: Each one of the things you make incremental progress every day , every week , every month , and every year . And I think it's why when we look out over a three , 5 or 10 year period , we're so optimistic about where this is all heading because it's all rooted in the right paradigm shift of clinical care .

Speaker #7: The rest of it , we have to keep our head down and keep executing against that . And if we do that , you're talking about a market opportunity , as you've heard me say many times , there are 21 or 22 million eyes in the United States with ocular hypertension or glaucoma , 12 to 13 million of those eyes today are already being actively treated .

Joe Gilliam: 12 to 13 million of those eyes today are already being actively treated, maybe imperfectly in the form of topical eye drops, but they're being treated. You compare that to what we're talking about in the earlier days of combination cataract and MIGS, where you had about $0.5 million eyes. When we look at this over a prolonged period of time, we expect the vast majority of procedures, irrespective of the tool, to be done in that standalone and interventional glaucoma market, purely because of the relative size of those market opportunities and the clinical need for that.

Speaker #7: Maybe imperfectly , in the form of topical eye drops . But they're being treated . You compare that to what we're talking about in the in the earlier days of combination cataract and MiGs , where you had about a half a million eyes , so when we look at this over a prolonged period of time , we expect that the vast majority of procedures , irrespective of the tool to be done in that standalone and interventional glaucoma market , sheerly , because of the relative size of those market opportunities and the clinical need for that .

Speaker #3: Thank you . And with no further questions in queue , I would like to turn the conference back over to the company for closing remarks .

Chris Lewis: Thank you. With no further questions in queue, I would like to turn the conference back over to the company for closing remarks.

Speaker #5: Okay . Thank you all for your time and attention today . And I want to thank you for your continued interest and support of glucose .

Thomas Burns: Okay, thank you all for your time and attention today. I want to thank you for your continued interest and support of Glaukos. Goodbye.

Speaker #5: Goodbye .

Chris Lewis: This concludes today's conference call. You may now disconnect.

Joe Gilliam: Sam.