Q4 2023 EyePoint Pharmaceuticals Inc Earnings Call
Operator: Good morning, my name is Kevin, and I'll be your conference operator today. At this time, I'd like to welcome everyone to the EyePoint Pharmaceuticals fourth quarter and full year 2023 financial results and recent corporate developments conference call. There will be a question and answer session to follow at the completion of the prepared remarks. Please be advised, this call is being recorded at the company's request.
Okay.
Good morning, My name is Kevin and I'll be your conference operator today at this time I'd like to welcome everyone to the eye point Pharmaceuticals fourth quarter and full year 2023 financial results and recent corporate developments conference call.
There'll be a question and answer session to follow.
Completion of the prepared remarks. Please be advised this call is being recorded at the company's request I would now like to turn the call over to George Ellison, Executive Vice President and Chief Financial Officer of Akamai Pharmaceuticals.
Operator: I wanna like turn the call over to George Elston, Executive Vice President and Chief Financial Officer of EyePoint Pharmaceuticals. Thank you and thank you all for joining us on today's conference call to discuss EyePoint Pharmaceuticals' fourth quarter and full year 2023 financial results and recent corporate development. With me today is Dr. Jay Duker, President and Chief Executive Officer.
Thank you and thank you all for joining us on today's conference call to discuss I point Pharmaceuticals fourth quarter and full year 2023 financial results and recent corporate developments with me today is Dr. Jay Duker, President and Chief Executive Officer and.
George O. Elston: Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for EYP 1901. I will close with commentary on the fourth quarter and full year 2023 financial results. We will then open the call to your questions.
Jay will begin with a review of recent corporate updates and discuss the ongoing clinical trials for E Y P 19 O one.
I will close with commentary on the fourth quarter and full year 2023 financial results. We will then open the call for your questions.
George O. Elston: Earlier this morning, we issued a press release detailing our financial results and recent operational developments. A copy of the release can be found in the Investor Relations tab on the corporate website www.eyepointpharma.com. Before we begin our formal comments, I'll remind you that various remarks we will make today constitute forward-looking statements for the purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995.
Earlier. This morning, we issued a press release detailing our financial results and recent operational developments a copy of the release can be found in the Investor Relations tab on our corporate website Www Dot I point pharma Dot com.
Before we begin our formal comments I'll remind you that various remarks, we will make today.
Forward looking statements for the purposes of the Safe Harbor provisions under the private Securities Litigation Reform Act of 1995.
George O. Elston: These include statements about our future expectations, clinical developments, regulatory matters, and timelines, as well as the potential success of our products and product candidates, financial projections, and our plans and processes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent annual report on Form 10-K, which is on file with the SEC, and in other filings that we may make with the SEC in the future. Any forward-looking statements represent our views as of today only. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our views change.
<unk> include statements about our future expectations clinical developments and regulatory matters and timelines.
Potential success of our products and product candidates financial projections, and our plans and prospects.
Actual results may differ materially from those indicated by these forward looking statements as a result of various important factors, including those discussed in the risk factors section of our most recent annual report.
And Form 10-K, which is on file with the SEC.
And in other filings that we may make with the SEC in the future.
Any forward looking statements represent our views as of today only while we may elect to update these forward looking statements at some point in the future. We specifically disclaim any obligation to do so even if our views change. Therefore, you should not rely on these forward looking statements as representing our views as of any date subsequent to today.
George O. Elston: Therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today. I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of EyePoint Pharmaceuticals. Thank you, George.
I'll now turn the call over to Dr. Jay Duker, President and Chief Executive Officer of <unk> Pharmaceuticals.
Jay S. Duker: Good morning, everyone, and thank you for joining us. 2023 was truly an exceptional year for EyePoint Pharmaceuticals on all fronts. We completed our transformation into a clinical-stage biopharmaceutical company with the out-license of the Utique franchise last spring for $82.5 million plus future royalty. We advanced our lead pipeline asset, EYP 1901, across three promising indications. Wet age-related macular degeneration, or wet AMD, non-proliferative diabetic retinopathy, or NPDR, and diabetic macular edema, or DME. We also significantly strengthened our balance sheet, ending 2023 with $331 million in cash and investments and no debt.
Thank you George Good morning, everyone and thank you for joining us.
<unk> thousand 23 was truly an exceptional year for <unk> pharmaceuticals on all fronts, we completed our transformation into a clinical stage biopharmaceutical company with the out license of the boutique franchise last spring for $82 $5 million plus future royalties.
We advanced our lead pipeline asset <unk> 19 O one across three promising indications wet age related macular degeneration or wet AMD, non proliferative diabetic retinopathy, or NPR and diabetic macular edema or <unk>, we also significantly strengthened our balance sheet.
Ending 2023 with $331 million in cash and investments and no debt.
Jay S. Duker: This is driven by the Utique sale and a $230 million over-subscribed follow-on equity offer. I'd like to review our recent progress for our lead product candidate, EYP1901, a potentially paradigm-altering treatment for patients suffering from VEGF-mediated retinal disease. In December, we reported positive top-line efficacy and safety data from our Phase 2 W02 clinical trial in wet AMD, achieving all primary and secondary endpoints. We expect to initiate the first pivotal Phase 3 wet MD trial, the Lugano trial, in the second half of this year, with the second pivotal trial, called the Lucia trial, to follow. We also look forward to reporting top-line data from the Phase 2 PAVIA clinical trial in the second quarter of this year and top-line data from the Phase 2 VIRONA trial in the first quarter of 2025.
This is driven by the Utica shale and a $230 million oversubscribed follow on equity offering.
I'd like to review our recent progress for our lead product candidate <unk> hundred one a potentially paradigm altering treatment for patients suffering from that Jeff mediated retinal diseases.
In December we reported positive top line efficacy and safety data from our phase two <unk> clinical trial in wet AMD, achieving all primary and secondary endpoints.
We expect to initiate the first pivotal phase III wet AMD trial, the Lugano trial in the second half of this year with the second pivotal trial called <unk> trial to follow.
We also look forward to reporting topline data for the phase two <unk>.
Clinical trial in the second quarter of this year and topline data from the phase II <unk> trial in the first quarter of 2025.
Jay S. Duker: As a reminder, EYP1901 is an investigational, sustained-release product that consists of arolanib, a selective and patent-protected tyrosine kinase inhibitor, or TKI, formulated in Duracert E, the bio-erodible version of our proprietary Duracert technology. Varroa, and it brings a new mechanistic approach to the treatment of VEGF-mediated retinal diseases by acting as a pan-VEGF receptor block, blocking all that Jeff I. In addition to the positive safety and efficacy data reported to date, virulent has also demonstrated neuroprotection in a validated retinal detachment animal model. Virolin may also have an antifibrotic effect as it blocks the PDGF receptor.
As a reminder, <unk> 19 O. One is an investigational sustained release product and it consists of a rolling in a selective and patent protected tyrosine kinase inhibitor or PKI formulated in <unk> E. The bio erodible version of our proprietary <unk> technology.
<unk> brings a new mechanistic approach to the treatment of that Jeff mediated retinal diseases by acting as a pan VEGF receptor blocker blocking all that Jeff isoforms. In addition to the positive safety and efficacy data reported to date for Roland <unk> has also demonstrated neuro protection in a validated retinal.
Attachment animal model.
We're rolling it May also have an anti fibrotic effect as it blocks the PDGF receptor.
Jay S. Duker: EYP 1901 is delivered by an intravitreal injection in the physician's office, similar to the current FDA-approved anti-VEGF biologic. However, unlike currently approved biologics and other sustained release anti-VEGFs in development, EYP1901 is shipped and stored at ambient temperature. Additionally, Virolinib, through Duracert E, is immediately bioavailable in the eye, featuring an initial burst of drug followed by a near-constant, zero-order kinetic release for up to nine months.
It might be 19, one is delivered by an <unk> injection in the physician's office similar to the current FDA approved anti VEGF biologic treatments.
Unlike currently approved biologics and other sustained release anti VEGF is in development. It might be 19, no one is shipped and stored at ambient temperature. Additionally.
Additionally for rolling through duress or E is immediately available in the eye featuring an initial burst of drug followed by our near constant as your order kinetic release for up to nine months.
Jay S. Duker: Our goal is to provide a product that maintains stable vision and retinal anatomy for the majority of wet AMD patients with an every six month label. This could represent a significant improvement compared to the current anti-VETGF treatments that are dosed on average every two months in the United States, and this may allow patients and practitioners the flexibility to reduce the number of visits without sacrificing visual output.
Our goal is to provide a product that maintained stable vision and retinal anatomy for the majority of wet AMD patients with an every six month label.
This could represent a significant improvement compared to the current anti VEGF treatments that are dosed on average every two months in the United States and this may allow patients and practitioners the flexibility to reduce the number of visits without sacrificing visual outcomes.
Jay S. Duker: Turning to the Phase 2 W02 non-inferiority clinical trial evaluating EYP1901 in previously treated wet MD patients as a potential maintenance therapy, all primary and secondary endpoints were achieved in this trial, including a statistically non-inferior change in best corrective visual acuity, or BCVA, versus the afflibriSep control for both EYP1901 arms. Non- Importantly, EYP 1901 continued to demonstrate a favorable safety profile, with no EYP 1901-related ocular or systemic serious adverse events, or SAEs, reported. We also saw an over 80% reduction in treatment burden, measured both prospectively and retrospectively, with strong anatomical control in both EYP 1901 cohorts. At the angiogenesis meeting in February, investigators reported that a subgroup of DAVIO2 patients remained anti-VEGF supplement-free up to six months after delivery of EYP1901. This subgroup demonstrated numerical superiority in change in BCVA along with strong anatomical control compared to the Aflibriscept control group.
Turning to the phase two <unk> two non inferiority clinical trial evaluating <unk> thousand 19 O. One in previously treated wet AMD patients as a potential maintenance therapy, all primary and secondary endpoints were achieved in this trial, including a statistically non inferior change in best corrected visual acuity or <unk> versus.
As the Flipper set control for both <unk> hundred one arms.
Non inferiority change in BCA is the most commonly used endpoints in wet AMD pivotal trials and subsequent FDA approval.
Accordingly, you might be 19, one continued to demonstrate a favorable safety profile with no <unk> 19, O unrelated ocular or systemic serious adverse events were reported.
We also saw it in over 80% reduction in treatment burden measured both prospectively and retrospectively with strong anatomical control in both E. P 19, one cohorts.
At the angiogenesis meeting in February investigators reported that a subgroup of <unk> patients remained anti VEGF supplement free up to six months after delivery of <unk> 19 I want.
This subgroup demonstrated numerical superiority and change in BCA, along with strong anatomical control compared to the Flipper set control group.
Jay S. Duker: This result confirms that the positive top-line data from the Phase 2 W02 trial were driven by EYP 1901 and not by supplemental injection. We anticipate initiating the Lugano Phase 3 trial in wet empty in the second half of 2024. And the second pivotal trial, Lucia, several months later. The Phase 2 W02 trial of EYP1901 was designed to mirror the anticipated design of the Phase 3 trials based on our Type C meeting with the FDA as well as other interactions. The key differences between W02 and the Phase III trials are that we anticipate that Phase III will feature redosing of EYP1901 every six months, the primary efficacy endpoint will be non-inferior change in BCV8 after approximately one year, and the two EYP1901 arms will be one or two inserts versus the two and three inserts used in W02. The decision to use 1 versus 2 inserts in the phase 3 trials is driven by the positive W02 data for both the 2mg and the 3mg doses. The Lugano Phase III trial will be conducted largely in the U.S., and the Lucia Phase III trial will include U.S. and ex-U.S. sites as we intend to seek EMA approval.
This result confirms that the positive topline data from the phase II <unk> trial were driven by <unk> 19, O one and not buy supplemental injections.
We anticipate initiating the Lugano phase III trial in wet AMD in the second half of 2024.
And the second pivotal trial with <unk> several months after the.
The phase II <unk> trial VIP 19, one was designed to mirror the anticipated design of the phase III trials based on our type C meeting with the FDA as well as other interactions.
The key differences between <unk> and the phase III trials are that we anticipate the phase III will feature re dosing of <unk> hundred one every six months.
The primary efficacy endpoint will be non inferior change and <unk> approximately one year.
<unk> two <unk> hundred one arms will be one or two inserts versus the two and three and search Houston W. Two.
The decision to use one versus two inserts in the phase III trials is driven by the positive <unk> data for both the two milligram and the three milligram doses.
Lugano Phase III trial will be conducted largely in the U S and the Wuxi a phase III trial will include U S and ex U S sites as we intend to seek EMA approval.
Jay S. Duker: We look forward to reviewing our plans at the end of the Phase 2 meeting with the FDA in April, and we expect to provide updates after those meeting minutes are received. As I mentioned earlier, we are on track to report top-line data from the Phase 2 PAVIA trial in 2Q of this year. PAVEA is a randomized controlled trial that evaluated EYP1901 as a potential nine-month treatment for moderately severe to severe NPDR. The trial enrolled 77 patients who were randomly assigned to one of two doses of EYP1901 or to the control group that received a sham injection.
We look forward to reviewing our plans at the end of Phase II meeting with the FDA in April and we expect to provide updates after those meeting minutes are received.
As I mentioned earlier, we are on track to report topline data from the phase II via trial in <unk> of this year the.
The VA is a randomized controlled trial evaluated you might be 19, no. One has a potential nine months treatment for moderately severe to severe NPD or the trial enrolled 77 patients who were randomly assigned to one of two doses of <unk> hundred one or to the control group that received a sham injection.
Jay S. Duker: There remains a great unmet need for a safe, efficacious, and convenient treatment for NPDR that proactively reduces the risk of progressing to site-threatening complications over the long term. Approximately 90% of patients with NPDR receive no course of treatment apart from observation by their eye doctors until their disease progresses to DME and or proliferative diabetic retinopathy. This is because the approved treatments are short-acting and therefore require frequent injections.
It remains a great unmet need for a safe efficacious and convenient treatment for NPD or that proactively reduces the risk of progressing to sight threatening complications over the long term.
Approximately 90% of patients with NPD art received no course of treatment apart from observation by their eye doctors on children disease progressed, the DMA and or proliferative diabetic retinopathy.
This is because the approved treatments are short acting and therefore require frequent injections. We believe you might be 19, one could potentially create a new market for NPD, our patients by providing an every nine months treatment option that matches the patient visit cadence into.
Jay S. Duker: We believe EYP1901 could potentially create a new market for NPDR patients by providing an every-nine-month treatment option that matches a patient's visit cadence. In the PAVEA trial, the primary endpoint is structural. A photograph of the retina is taken on day one of the study and then compared to a photograph taken at month nine. A reading center independently evaluates the photographs to assess the degree of retinopathy on the diabetic retinopathy severity scale, abbreviated as DRSS.
In the VA trial. The primary endpoint is structural a photograph of the retina is taken on day one of the study and then compared to a photograph taken at month nine our reading center independently evaluates the photographs to assess the degree of retinopathy on the diabetic retinopathy severity scale, abbreviated D. R. S S.
Jay S. Duker: The DRSS is a well-validated measure that correlates the functional outcome with the anatomic outcome. The accepted clinically relevant step change is a two-step reduction in the scale. In the PAVEA trial, we are looking for at least one-third of the patients to show a greater than or equal to a two-step reduction on the DRSS scale at nine months. It's important to note that this is a lower limit and
<unk> is a well validated measure that correlates to the functional with the anatomic outcomes. The accepted clinically relevant step change demonstrates a two step reduction and the scale.
And the VA trial, we are looking for at least one third of the patients to show a greater than or equal to two step reduction on the drs's scale at nine months. It's important to note that this is a lower limit and not an expectation. We will also be looking at important secondary endpoints, including reduction in vision threatening complications.
Jay S. Duker: We will also be looking at important secondary endpoints, including reduction in vision-threatening complications, prevention of DME and proliferative diabetic retinopathy, degree of retinal ischemia, and safety. Consistent with our results to date for this program, we expect to see a continued favorable safety profile, a critical factor in any retinal drug. Turning to our third indication, in January, we initiated the Phase 2 Verona trial evaluating EYP1901 and a second diabetic eye disease indication, DME, a sight-threatening complication of diabetes that can lead to severe visual loss. Similar to wet AMD, this is a VEGF-mediated disease where there is a significant need for differentiated and longer-acting treatments. Verona is a randomized, controlled single mast phase two trial of EYP1901 in DME patients previously treated with standard of care anti-VEGF therapy.
Prevention of DNA, and proliferative diabetic retinopathy degree of retinal ischemia and safety.
Consistent with our results to date for this program, we expect to see a continued favorable safety profile a critical factor in any retinal drug.
Turning to our third indication in January we initiated the phase II <unk> trial evaluating <unk> thousand 19 to went into second diabetic eye disease indication DMA.
Threatening complication of diabetes that can lead to severe visual loss.
Similar to wet AMD. This is a VEGF mediated disease, where there is a significant need for differentiated and longer acting treatments for.
Kona is a randomized controlled single masked phase II trial of <unk> 19 in one in DMD patients previously treated with standard of care anti VEGF therapy.
Jay S. Duker: The three-arm trial is expected to enroll approximately 25 patients randomized to one of two doses of UIP-1901 or to a flibrisep control. The primary efficacy endpoint of the Verona trial is time to first anti-VEGF supplementation for up to 24 weeks based on established criteria. Secondary endpoints include safety, change in BCVA, change in central subfield thickness as measured on OCT, and change in DRSS over time. We remain on track to report top-line data from the Verona trial in the first quarter of 2025. We remain highly encouraged by the growing body of positive clinical data for EYP19-01, and we are optimistic that EYP19-01 has the potential to change the current treatment paradigm for VEGF-mediated retinal disease. Turning to our pipeline programs, we announced a new preclinical program, EYP2301, which delivers a promising tie to agonists, raciprotofib, formerly known as AKB9778, We believe that delivering EYP2301 intravitrially has the potential to offer new site-saving treatment for patients with severe retinal disease, either alone or in combination with anti-VEGF. We continue to evaluate additional molecules for sustained delivery in Duracert E, including complement inhibition and rare diseases, and hope to update you on these programs later this year.
The three arm trial is expected to enroll approximately 25 patients randomized to one of two doses of <unk> 19 in one or in a flipper set control. The primary efficacy endpoint of the Verona trial is time to first anti VEGF supplement up to 24 weeks based on established criteria.
Secondary endpoints include safety change in D. CPA change in central subfield thickness as measured on OTT and change in Drs overtime.
We remain on track to report topline data from the Verona trial in the first quarter of 2025.
We remain highly encouraged by the growing body of positive clinical data for <unk>, one and we are optimistic that <unk> 90 to one has the potential to change the current treatment paradigm for <unk> mediated retinal diseases.
Turning to our pipeline programs, we announced a new preclinical program <unk> 301, which delivers a promising tie two agonists rasp prototype, formerly known as <unk> 970, 708 formulated into Richard E. <unk> prototype is an inhibitor of vascular endothelial protein tyrosine.
For days or V E. PTP, we believe that delivering <unk> 23, a one <unk> truly has the potential to offer new site saving treatment for patients with severe retinal disease, either alone or in combination with anti vet Jeff's, we continue to evaluate additional molecules for sustained delivery in <unk>.
Richard E, including complement inhibition and rare diseases and hope to update you on these programs later this year.
Last I am delighted to welcome Ramiro Ribeiro M D ph D to I point as our new Chief Medical Officer, Dr. Roberto was a trained retinal specialists, who joins us from <unk> Pharmaceuticals, where he served as vice President head of clinical development and we're confident that his proven leadership and strong scientific and clinical background.
Jay S. Duker: Last, I'm delighted to welcome Ramiro Ribeiro, MD, PhD, to EyePoint as our new chief medical officer. Dr. Ribeiro is a trained retinal specialist who joins us from Apellis Pharmaceuticals, where she served as vice president, head of clinical development. And we're confident that his proven leadership and strong scientific and clinical background will be a tremendous asset to the EyePoint team. I'd like to thank Dr. Dario Padrino, who served as our chief medical officer for the past seven years. To close, I want to thank the entire EyePoint team for an incredible 2023 and a strong start in 2024. The impressive execution and dedication demonstrated by our team to reach these milestones reflects the entire organization's commitment to patients. In addition, I'd like to thank the patients and clinical investigators for their participation in the ongoing trials.
<unk> will be a tremendous asset to the <unk> team.
To thank Dr. Dario Petrino, who served as our Chief Medical officer for the past seven years.
To close I want to thank the entire <unk> team for an incredible 2023, and a strong start in 2024.
<unk> execution and dedication demonstrated by our team to reach these milestones reflects the entire organizations commitment to patients.
In addition, I'd like to thank the patients and clinical investigators for their participation in the ongoing trials without you all the progress we've made advancing <unk> thousand 19, one would not be possible.
With our compelling clinical pipeline representing potential multibillion dollar product opportunities are best in class sustained ocular delivery to research <unk> technology, along with our strong balance sheet, we are well positioned to grow as a leader in ocular drug delivery and to bringing impactful therapies to patients suffering from serious retinal diseases.
Jay S. Duker: Without you all, the progress we've made advancing EYP1901 would not be possible; with our compelling clinical pipeline representing potential multi-billion dollar product opportunities, our best-in-class sustained ocular delivery RASERT-E technology, along with a strong balance sheet, we're well positioned to grow as a leader in ocular drug delivery and to bring impactful therapies to patients suffering from serious retinal disease. I will now turn the call over to George to review the financials.
I will now turn the call over to George to review the financials George.
Thank you Jay before we review the financial results 2023 was an exceptional year for our financial performance as Jay noted we ended 23 with a strong balance sheet driven by the out license of Utica. The retirement of outstanding Bank debt in an oversubscribed $230 million follow on financing in December resulting in.
$331 million of cash and investments at December 31.
George O. Elston: Thank you, Jay. Before we review the financial results, 2023 was an exceptional year for our financial performance. As Jay noted, we ended 23 with a strong balance sheet driven by the out-license of Utique, the retirement of outstanding bank debt, and an over-subscribed $230 million follow-on financing in December, resulting in $331 million of cash investments at December 31. As the financial results for the three months and full year ended December 31st, 2023, were included in the press release issued this morning, my comments today will be focused on the high-level For the quarter ended December 31st, 2023, total net revenue was $14 million compared to $10.5 million for the quarter ended December 31st, 2022. Net product revenue for the quarter ended December 31, 2023 was $0.7 million compared to net product revenue for the quarter ended December 31, 2022 of $9.9 million.
As the financial results for the three months and full year ended December 31, 2023 were included in the press release issued this morning. My comments today will be focused on a high level review for the quarter.
For the quarter ended December 31, 2023, total net revenue was $14 million compared to $10 5 million for the quarter ended December 31 2022.
Net product revenue for the quarter ended December 31, 2023 was <unk> 7 million compared to a net product revenue for the quarter ended December 31, 2022 of $9 9 million.
This decrease in net product revenue resulted from our strategic exit from the commercial business in the first half of 2023 highlighted by the out license of Utica in May.
Net revenue from royalties and collaborations for the quarter ended December 31, 2023 totaled $13 3 million compared to $6 million in the corresponding period in 2022.
The increase was primarily due to partial recognition of deferred revenue from the license of the Utica franchise, which began in the second quarter of 2023 and will be recognized over a two year period in connection with the delivery of Utica supply units.
Operating expenses for the quarter ended December 31, 2023 totaled $30 4 million compared to $54 3 million in the prior year period.
George O. Elston: This decrease in net product revenue resulted from our strategic exit from the commercial business in the first half of 2023, highlighted by the outlicensing of Utique in May. Net revenue from royalties in collaboration for the quarter ended December 31, 2023, totaled $13.3 million, compared to $0.6 million in the corresponding period in 2022. The increase was primarily due to partial recognition of deferred revenue from the license of the Utique franchise, which began in the second quarter of 2023 and will be recognized over a two-year period in connection with the delivery of Utique supply units. Operating expenses for the quarter ended December 31, 2023 totaled $30.4 million compared to $54.3 million in the prior year period. This decrease was primarily driven by the strategic exit from the commercial business in the first half of 2023 and a one-time intangible asset impairment charge in the fourth quarter of 2022. Non-operating income totaled $2.3 million, and net loss was $14.1 million, or $0.33 per share loss, compared to a net loss of $43.5 million or $1.16 per share loss for the prior year period.
This decrease was primarily driven by the strategic exit from the commercial business in the first half of 2023, and a one time intangible asset impairment charge in the fourth quarter of 2022.
Non operating income totaled $2 3 million in net loss was $14 1 million or <unk> 33 per share loss compared to a net loss of $43 5 million or $1 16 per share loss for the prior year period.
Turning to the full year ended December 31, 2023, total net revenue was $46 million compared to $41 4 million for the year ended December 31, 2022 net product revenue for the full year ended December 31, 23 was $14 2 million compared to net product revenues for the full year ended December 31, two.
22 of $39 9 million.
Net revenue from royalties and collaborations for the full year ended December 31, 2023 totaled $31 8 million compared to $1 $5 million in the corresponding period in 2022.
Operating expenses for the full year ended December 31, 2023 totaled $121 1 million versus $141 million in the prior year period.
Net non operating expense totaled $4 4 million and net loss was $70 8 million or $1 82 per share compared to a net loss of $102 3 million or $2 74 per share for the prior year period.
George O. Elston: Turning to the full year end of December 31st, 2020, total net revenue was $46 million, compared to $41.4 million for the year-ended December 31st, 2022. Net product revenue for the full year ended December 31st, 2023 was $14.2 million, compared to net product revenues for the full year ended December 31st, 2022 of $39.9 million. Net revenue from royalties and collaborations for the full year ended December 31, 2023 totaled $31.8 million, compared to $1.5 million in the corresponding period. Operating expenses for the full year ended December 31, 2023 totaled $121.1 million versus $141 million in the prior year period. Net non-operating expense totaled $4.4 million, and the net loss was $70.8 million, or $1.82 per share, compared to a net loss of $102.3 million, or $2.74, for the prior year period.
Cash and investments and marketable securities on December 31, 2023 totaled $331 1 million compared to $144 6 million as of December 31, 2022.
We expect the cash and investments on December 31, 2023 will fund us through top line data for the planned phase III clinical trials of <unk> 19 O. One for wet AMD. In 2026. This also includes completion of the ongoing phase II clinical trials for <unk> hundred one in wet AMD and PDR.
And dnb.
In conclusion, we are pleased with <unk> progress in 2023 and are well capitalized to advance our product pipeline to key value inflection points.
I'll now turn the call back over to Jay for closing remarks.
Thank you George.
As we discussed I point is the story of execution and positive data, we've accomplished our clinical milestone sufficiently and on track with our guidance and we plan to continue this track record in 2024 and beyond.
Key upcoming catalysts include topline data from our phase II via clinical trial in the second quarter of 2024.
And end of Phase II meeting with the U S. FDA in April and initiation of the first non inferiority pivotal phase III Lugano trial of <unk> 19 in one in wet AMD in the United States in the second half of this year.
George O. Elston: Cash and investments in marketable securities on December 31, 2023 totaled $331.1 million compared to $144.6 million as of December 31, 2022. We expect the cash and investments on December 31st, 2023 will fund us through top-line data for the planned phase three clinical trials of EYP 1901 for wet AMD in 2026. This also includes completion of the ongoing Phase II clinical trials for EYP 1901 in wet AMD and PDR and DME. In conclusion, we are pleased with EyePoint's progress in 2023 and are well capitalized to advance our product pipeline to key value inflection points. I'll now turn the call back over to Jay for closing.
Enrollment completion of the phase III <unk> clinical trial of <unk> thousand 19, I wanted <unk> with topline data expected in the first quarter of 2025.
And earlier stage pipeline program advancement towards clinical development.
This remains an incredibly exciting time for <unk> as we are well positioned to execute on our upcoming milestones and continued to transform the treatment landscape with innovative long term solutions to improve both the vision and the lives of patients with serious retinal diseases.
Thank you very much for listening. This morning, I will now turn it over to the operator for questions.
Thank you ladies and gentlemen, if you have a question or a comment at this time. Please press star one on your telephone. If your question has been answered or you wish to move yourself from the queue. Please press star one again and then the interest of time and to accommodate everybody. My questions. We ask that you limit yourself to one question, we will pause for a moment, while we compile our Q&A roster.
Jay S. Duker: Thank you, George. As we've discussed, EyePoint is a story of execution and positive data. We've accomplished our clinical milestones efficiently and on track with our guidance, and we plan to continue this track record in 2024 and beyond. Key upcoming catalysts include top-line data from our Phase 2 PAVEA clinical trial in the second quarter of 2024, an end of Phase 2 meeting with the U.S. FDA in April, and initiation of the first non-inferiority pivotal Phase 3 Lugano trial of EYP1901 Enrollment completion of the Phase 2 Verona clinical trial of UIP-1901 and DME with top-line data expected in the first quarter of 2025 and earlier stage pipeline program advancement toward clinical development.
Our first question comes from Tessa Romero with Jpmorgan. Your line is open.
Hello, Good morning, guys. Thanks for taking our question.
How do you think about the potential opportunities you IP 19 line.
To provide a little bit of further context around.
How you think about further segmenting the PDR population.
Out of the 6 million in PDR patients.
Which patients GSE.
More low hanging fruit.
For potential therapy. Thank you.
Thank you tests before it gets to the answer I just like to take this opportunity to introduce our new CMO, Dr. Ramiro Ribeiro who's here with George and obviously.
Operator: This remains an incredibly exciting time for EyePoint as we are well positioned to execute on our upcoming milestones and continue to transform the treatment landscape with innovative long-term solutions to improve both the vision and the lives of patients with serious retinal disease. Thank you very much for listening this morning. I will now turn it over to the operator for questions. Thank you. Ladies and gentlemen, if you have a question or a comment at this time, please press star one one on your telephone. If your question has been answered, or you wish to move yourself from the queue, please press star one one again.
Thanks, Jay Firstly, I want to say that I'm very privileged to join the <unk> team Im a retina specialist by training after working private practice I move to the U S. As part of my Phd program, where <unk> research after some timing academic sandton setting.
Patients, who biotech mainly small biotech, but always ophthalmology.
Spent time at <unk> Tec.
The four reset trial for wet AMD at Casella doing staggered disease and recently I was the head of clinical development at a palace.
I'll add the clinical team from inception of the phase III protocol execution of the global triumphs rig with our submission and last year the approval cycle.
Operator: And in the interest of time and to accommodate everybody in the question queue, we ask that you limit yourself to one question. We'll pause for a moment while we compile our Q&A roster. Our first question comes from Tess Romero with J.P. Morgan. Your line is open.
The first therapy for RGA.
Joined Knifepoint for three reasons first because I believe in the technology that you bring options for patients with better conditions.
Second the strong <unk> results from diabetes.
Jay S. Duker: Hello, good morning guys. Thanks for taking our question. As you think about the potential opportunity for EYP-19-01, are you able to provide a little bit of further context around how you think about further segmenting the NPDR population? And out of the 6 million NPDR patients here in the U.S., which patients do you see as the more low-hanging fruit for potential therapy? Thank you. Thank you, Tess.
And lastly, the retina community is very small and I point has a reputation of being a strong scientific company and I always put patients in the first place.
Okay. So thanks for now and test back to your question.
The obvious answer is that is that has the most severe NPD are the logical first group that clinicians might treat because those are eyes that have high risk to go on to sight, threatening complications like CME and PDR by preventing.
Ramiro Ribeiro: Before I get to the answer, I'd just like to take this opportunity to introduce our new CMO, Dr. Ramiro Ribeiro, who's here with George and me. Thanks, Jay. First, I want to say that I'm very privileged to join the EyePoint team. I'm a retina specialist by training. After working in private practice, I moved to the US as part of my PhD program, where I really fell in love with research. After some time in an academic setting, I transitioned to biotech, mainly small biotech, but always in ophthalmology.
Or at least delaying significantly the advancement of two dose sight threatening complications.
<unk> <unk> 19, <unk> potentially once every nine months approximately we think we can really improve patients' lives by preventing visual loss in preventing the eventual need for multiple injections over years.
Okay.
Thank you one number for our next question.
Our next question comes from Tyler Van Buren with TD Cowen Your line is open.
Great. Thanks, Good morning, congratulations on all the progress during the quarter for.
Ramiro Ribeiro: I spent time at OptoTec doing the FOVISA trial for wet MD, at Acrisela doing a staggered disease, and recently, I was the head of clinical development at Appellus, where I led the clinical team from the inception of the phase three protocol, execution of the global trials, regulatory submission, and last year, the approval of Cyphovir, the first therapy for GH. I joined EyePoint for three reasons.
The planned end of phase two meeting with the FDA next month regarding your phase III plans can you elaborate on the key discussion topics.
What extent you discussed your development strategy prior to initiating W. Two as we think about the interactions you've already had with the FDA.
Yeah. Thanks Tyler.
So.
Ramiro Ribeiro: First, because I believe in the technology that will bring options for patients with better conditions. Second, the strong and very convincing results from the IV-2. And lastly, the retina community is very small, and EyePoint has a reputation of being a strong scientific company that always puts patients in the first place. Thanks, Ramel. And, Tess, back to your question. I think the obvious answer is that eyes that have the most severe NPDR are the logical first group that clinicians might treat because those are the eyes that are at high risk of going on to site-threatening complications like DME and PDR.
The second part of your question I think I'll answer first which is.
Sharing and discussion of our development plans with the FDA.
As we've said in the past there was considerable discussion within the company and with the agency several years ago to go straight from our phase <unk> trial into pivotal trials in wet AMD.
As a result of that discussion we had a type C meeting with the FDA.
Further discussion after the type C meeting at which point the agency and the company had had reached a general let's call. It an agreement over the protocol for potential phase III.
Jay S. Duker: By preventing, or at least significantly delaying, the progression to those site-threatening complications, using EYP1901 potentially once every nine months, approximately, we think we can really improve patients' lives by preventing visual loss and preventing the eventual need for multiple injections over years. Thank you. One moment for our next question. Our next question comes from Tyler Van Buren with TD Cowen. Your line is open.
We then made the strategic decision to do.
A more I'd say traditional phase II program prior to the phase III of course that was the <unk> two program.
And we took the agency's advice.
Instructions learnings from the end of Phase two meeting in subsequent communications and develop the protocol for W. Two out of those discussions and therefore.
Operator: Great, thanks. Good morning. Congratulations on all the progress during the quarter. For the plans and a Phase 2 meeting with the FDA next month regarding your Phase 3 plan, can you elaborate on the key discussion topics and to what extent you discussed your development strategy prior to initiating W2 as we think about the interactions you've already had with the FDA?
Sure.
Optimistic and I'd say going into the end of phase two meeting confident about most of the large.
Touch points around our pivotal trial design.
So in the first part of the question you asked about key topics.
Jay S. Duker: So the second part of your question, I think I'll answer first, which is the sharing and discussion of our development plans with the FDA. As we've said in the past, there was considerable discussion within the company and with the agency several years ago to go straight from our Phase 1 W trial into pivotal trials in wet AMD. As a result of that discussion, we had a Type C meeting with the FDA and further discussions after the Type C meeting, at which point the agency and the company had reached a general agreement over the protocol for potential Phase 3. We then made the strategic decision to do a more, I'd say, traditional phase two program prior to phase three. Of course, that was the W2 program.
I'm not sure that I can point to anything in particular as a key topic, we've kind of again.
The seat general agreement on a non inferiority trial with a minus four five.
Non inferiority margin all of this is kind of standard and was restated clearly in the draft guidelines.
I'm not sure those kind of issues really bubble up to the use of turn key we have some other questions around some inclusion exclusion criteria, which will.
I'll hopefully be made clear in the meeting and also some issues around the safety cohort that we need to show the FDA, but again I'm optimistic that these will all be straightforward and relatively simple for the agency and us to come to agreement.
Jay S. Duker: And we took the agency's advice, instructions, and learnings from the end of phase two meeting and subsequent communications and developed the protocol for W2 out of those discussions. And therefore, we're optimistic about going into the end of phase two meeting confident about most of the large touch points around our pivotal trial design. So, in the first part of the question, you asked about key topics. I'm not sure that I can point to anything in particular as a key topic.
Okay. Thank you one moment for our next question.
Our next question comes from Justin <unk> with Guggenheim. Your line is open.
Hey, guys. Thank you for taking my question.
Quick one for me this is more of a clarification.
And PDR, Jay you've talked about that.
About 30% to 35% response rate that youre more move forward, but if you look at the data from that.
Yes, they are in the 45% to 50% range. So just curious like what you heard from the community like why you move forward that at that level and then also in this particular study that you're also looking at the BCBS I apologize if you already commented about that but curious to understand how.
Jay S. Duker: We're going to, again, seek general agreement on a non-inferiority trial with a minus 4.5 non-inferiority margin. All of this is kind of standard and was restated clearly in the draft guidelines. So I'm not sure those kinds of issues really bubble up to use the term key.
<unk> dynamics should be measured and what the expectation there are.
Jay S. Duker: We have some other questions around some inclusion and exclusion criteria, which will hopefully be made clear in the meeting, and also some issues around the safety cohort that we need to show the FDA. But again, I'm optimistic that these will all be straightforward and relatively simple for the agency and us to come to agreement on. Thank you. Please take a moment for our next question. Our next question comes from Yatin Suneja on Guggenheim. Your line is open. Hey guys,
Sure and thanks for the questions so that.
Kind of floor I would say for where step improvement in the Rss for NPD. Our trial is really based on what many of the Kols and doctors in the community have told us that if our drug is safe and effective and can be dosed or perhaps every nine months.
They would use it in.
Jay S. Duker: Thank you for taking my question. Quick one for me, or this is more of a clarification on NPDR. Jay, you've talked about, you know, that if you see about a 30-35% response rate there, you would move forward. But if you look at the data from, you know, VEGFs, they are in the 45-50% range. I'm just curious, like, what you heard from the community, like, why you moved forward at that level.
Suitable number of their NPD, our patients if there was even a one out of three rate of improvement.
The rate of improvement.
That the current approved therapy show 50, 60, 70% yes.
I have to say, it's great, but it's almost irrelevant because there has to be given so frequently that practitioners and patients really are to a large degree participate.
Jay S. Duker: And then also, in this particular study, are you also looking at the BCVA? I apologize if you have already commented on that, but curious to understand how the BCVA dynamics should be measured and what the expectations there are. Sure, Yatin, thanks for the questions.
The other thing about NPD are while there isn't an immediate feedback.
A biomarker to the clinician as to whether your drug is working or not the questions are able over time to re evaluate the degree of diabetic retinopathy in NII and make their assessment and the office of whether that patient is benefiting from the therapy or isn't so if you have a safe effective bio erodible therapy and it isn't working in the clinic.
Jay S. Duker: So that kind of floor I would say for step improvement in the DRSS for NPDR trial is really based on what many of the KOLs and doctors in the community have told us, that if our drug is safe and effective and can be dosed perhaps every nine months, they would use it in a considerable number of their NPDR patients if there was even a one out of three rate of improvement. You know, the rate of improvement that the current approved therapies show, 50, 60, 70 percent, you know, I have to say it's great, but it's almost irrelevant because they have to be given so frequently that practitioners and patients really are to a large degree participating. The other thing about NPDR, while there isn't an immediate feedback with a biomarker to the clinician as to whether your drug is working or not, the clinicians are able over time to re-evaluate the degree of diabetic retinopathy in NEI and make their assessment in the office of whether that patient is benefiting from the therapy or not.
Clinicians could simply not beat it.
So we do think that we're going to be able to work with the community to find the best patients for the treatment and help them decide whether continued treatment is in the patients best interest.
As for <unk>.
It's not a.
Primary endpoint most of these <unk> patients have relatively good best corrected visual acuity and.
And PDR in and of itself.
Yes, there is quite a bit of macular ischemia involved and it typically retain good vision. So it's something that we were obviously be measuring but we don't expect significant changes in BCA.
Jay S. Duker: So if you have a safe, effective, biorotable therapy and it isn't working, then clinicians could simply not impede it. So we do think that we're going to be able to work with the community to find the best patients for the treatment and help them decide whether continued treatment is in the patient's best interest. As for BCVA, it's not a primary endpoint. Most of these NPDR patients have relatively good best corrected visual acuity. And NPDR, in and of itself, unless there's quite a bit of macular ischemia involved in it, typically retains good vision.
Either the treatment and control arms.
Thank you one moment for our next question.
Our next question comes from Jennifer <unk> with Cantor Fitzgerald. Your line is open.
Hey, guys. Thanks for taking my question and Dr. <unk> Bureau, glad to see another retina guy on the team.
Maybe to touch up on the last question.
<unk> and PDR is around the corner what do you think is the most important read through from the NPD are steady to the Dms steady given the differences in endpoint.
The payload and then Karen and the different duration of therapy.
I guess ultimately what kind of profile.
Are there market dynamics are you assuming when you talk about modeling potential billion dollar plus opportunity and Dr and Jamie Thanks.
Jay S. Duker: So it's something that we will obviously be measuring, but we don't expect significant changes in BCVA in either the treatment or the control arms. Thank you. One moment for our next question. Our next question comes from Jennifer Kim with Cantor Fitzgerald. Your line is open. Hey guys, thanks for taking my question. And Dr. Riviero, glad to see another retina guy on the team. Maybe to touch up on the last question, since NPDR is around the corner, what do you think is the most important takeaway from the NPDR study to the DME study, given the differences in endpoints and the payload of the inserts and the different duration of therapy? And I guess ultimately, what kind of profile do you want?
Sure.
Thanks, Jennifer So I think the number one read through is up until the Pavia trial, we hadn't dose <unk> one in diabetic population.
And so obviously, we're looking for some basic.
<unk> stepped that in this population that has a VEGF mediated disease that are in service work and are safe and I can just remind everybody that we did released interim safety data as of last November the <unk> trial, and we had no.
<unk> unrelated ocular systemic complications.
Jay S. Duker: Are there other market dynamics you are assuming when you talk about modeling a potential billion dollar plus opportunity in DR and DME? Thanks. Thanks, Jennifer. So, the number one read through is that up until the PAVEA trial, we hadn't dosed EYP-1901 in a diabetic population. And so obviously, we're looking for some, you know, basic acknowledgements that in this population that has a VEGF-mediated disease, our inserts work and are safe. And I can just remind everybody that we did release interim safety data as of last November in the PAVEA trial, and we had no virulent or EYP-1901-related ocular systemic complications. So the read-through primarily will be, you know, can we show a benefit in this particular disease? DME is an extension of NPDR, just like PDR is an extension. As eyes get more ischemic, and presumably VEGF levels and other cytokine levels go up, that's when you start to see this type of leakage in new blood vessels.
So the read through were primarily will be can we show a benefit in this particular disease.
<unk> is an extension of MTR, just like PDR is an extension as I get more ischemic and presumably VEGF levels and other silicon levels go up higher that's when you start to see this type of leakage of new blood vessels, and therefore, I think if we can show in the NPD our population.
We are making a biological improvement I think there'll be definitely read through the DMA.
As to the differences in the studies and the insert payloads shouldnt matter insert payloads again, they release almost identically they give levels that are consistent with the payload as opposed to.
The difference in the actual inserts. So I don't think those particular aspects of the differences between the Verona trial. The Pavia trial will be of any significance at all.
Thank you one moment for our next question.
Okay.
Jay S. Duker: And therefore, I think if we can show in the NPDR population that we are making a biological improvement, I think that we definitely read through the DME. As to the differences in the studies, in the insert payloads, shouldn't matter. Insert payloads, you know, again, they release almost identically; they give levels that are consistent with the payload as opposed to, you know, the difference in the actual inserts. So, I don't think those particular aspects of the differences between the Voronatra and the Pavitra will be of any significance at all.
Our next question comes from Greg <unk> with Mizuho Securities. Your line is open.
Good morning, Thank you for taking my question.
I was curious.
In light of the data that you presented in wet AMD and <unk>.
<unk> have you been able to do any.
Perhaps new market research with either clinicians are payers.
On their reactions and if you have what were the findings if you will.
Haven't done that maybe you could just provide us a general big picture comment around what the feedback from the retinal specialist community has been thank you.
Jay S. Duker: Thank you. One moment for our next question. Our next question comes from Greg Savinje with Mizzou Hill Securities. Your line is open.
Thanks, Greg that's a great question and while I would say the formal aspects of both.
Operator: Good morning. Thank you for taking my question. I was curious, in light of the data that you presented on WebMD and in the time since, have you been able to do any new market research with either clinicians or payers on their reactions? And if you have, what were the findings?
Market research for both payers and practitioners is ongoing.
And since it is ongoing I really can't comment on how the new data has changed.
Jay S. Duker: And if you haven't done any, maybe you could just provide us with a general big-picture comment around what the feedback from the retinal specialist community has been. Thank you. Thanks, Greg. It's a great question.
In a quantitative formal way what the practitioners and the payers are thinking about your wife and 19, one I can say again.
Jay S. Duker: And while I would say the formal aspects of market research for both payers and practitioners are ongoing, and since it is ongoing, I really can't comment on how the new data has changed in a quantitative, formal way what the practitioners and the payers are thinking about EYP 1901. I can say, again, in a rather qualitative way, the initial interactions we have had with the payers are quite positive. And the practitioners, the same, you know, again, the data from W02 was excellent. We had essentially no change in visual acuity over the six months after our inserts went in compared to the idea of control.
Rather qualitative way.
The initial interactions we have and the payers are quite positive.
And the practitioners to say.
Again, the data from <unk> two was excellent.
We had no essentially no change in visual acuity over the six months after our inserts when compared to the idea of control and we did it with a really in tax safety record and anatomic data that really went along with the visual acuity data. So as the retina community is exposed to not.
Only the initial data set but the subsequent subset analysis I think the enthusiasm amongst the potential for this is definitely growing.
Jay S. Duker: And we did it with a really intact safety record and anatomic data that really went along with the visual acuity data. So, as the retina community is exposed to not only the initial data set but the subsequent subset analysis, I think the enthusiasm amongst the potential for this is definitely growing. And at a recent conference, I think when polled of the new agents that are available, the polled retina specialists put EYP 1901 as the most exciting. So I think our message in our great data is getting out there, and I think it will continue to be well received in both those communities.
And in a recent.
Okay.
Conference.
I think when polled.
The new agents that are available there pulled retina specialists put EUR 19, one is the most exciting so I think our message and our great data is getting out there and I think it will continue to be well received in both those communities.
Thank you one moment for our next question.
Okay.
Our next question comes from the quality and <unk> with Baird. Your line is open.
Great. Thanks, Good morning, Thanks for taking our questions on the web.
Operator: Thank you. One moment for our next question. Your next question comes from Colleen Kusy with Baird. Your line is open. Great. Thanks. Good morning.
The phase III design, maybe this is something that will that youll get more feedback on your FDA meeting, but can you talk about your understanding of the role of the low dose arm in the pivotal study design do you need to be better than the low dose or is that just for masking purposes, and if you do have to be better is that statistically significantly better or just a favorable trend. Thanks.
Operator: Thanks for taking our questions. On the wet AMD Phase 3 design, maybe this is something that you'll get more feedback on in your FDA meeting, but can you talk about your understanding of the role of the low-dose arm in the pivotal study design? Do you need to be better than the low dose, or is that just for masking purposes? And if you do have to be better, is that statistically significantly better, or just a favorable trend?
Yeah. Thanks Kali.
So in our interactions with the FDA.
The second arm of our drug was viewed as a way to improve the masking in the study.
Jay S. Duker: Yeah, thanks, Colleen. In our interactions with the FDA, the second arm of our drug was viewed as a way to improve the masking in the study. There was never any indication or suggestion that the lower dose had to perform necessarily any different than the higher dose.
There was never any.
Indication or suggestion that the lower dose had to perform necessarily any different than the higher dose.
Jay S. Duker: However, as we've talked about, the second reason we want to use two doses is that there was no dose response in W2. Two milligrams and three milligrams worked essentially equivalently. And therefore, we want the opportunity to test the dose that's around two milligrams and another dose that's possibly lower than that which would be delivered by a single insert. And we hope to and expect to power the trial enough that the lower dose could show non-inferiority against the affliver set control group. Thank you. Please take a moment for our next question. Our next question comes from Yale Gen with Laidlaw & Company. Your line is open.
As we've talked about the second reason, we want to use two doses is that there was no dose response in <unk> to two milligrams and three milligrams worked essentially equip equivalent with and therefore, we want the opportunity to test the dose that's around two milligrams and another dose thats, possibly.
Lower that would a dose to be delivered by a single insert.
And we hope to and expect to.
Powered the trial enough that the lower dose could show non inferiority against the flippers of controller.
Thank you one moment for our next question.
Our next question comes from Yale Jen with Laidlaw <unk> Company. Your line is open.
Operator: Good morning. Thanks for taking the question. Just for the DME, I know it's probably a little bit later to happen, and in terms of 1901, what could its role play any differently in terms of the potential paradigm differences between the DME and the wet AMD?
Good morning, Thanks for taking the questions.
Just for the <unk>.
It's probably a little bit.
Later to happen.
And in terms of.
And that deal was what its real clip plates.
Any differently in terms of the potential paradigm.
Jay S. Duker: Thanks, y'all. That's a really good question, and it speaks to the differentiation between the two diseases as to how they respond to anti-VEGF. DMV patients do respond to anti-VEGFs, but the anatomic response is often delayed and takes multiple injections to actually see that response. Therefore, a sustained release insert like EYP19-01 might not show a response faster than an anti-VEGF, but we would expect and hope that if the population of diabetics responds the same way that the wet AMD population responds, we can show a similar benefit to other anti-VEGF That would be my goal.
<unk>.
Between <unk> and <unk>.
What AMD.
Thanks, Jeff that's a really good question and it speaks to the differentiation in the two diseases of how they respond to anti bad jeffs.
AMD patients do respond to anti VEGF, but the anatomic response is often delayed it takes multiple injections to actually see that response.
Therefore.
Sustained release in serve like <unk> thousand 19 at one <unk>.
Not show a response faster than an anti VEGF, but we would expect and hope that if the population is.
Diabetics responds the same way that the wet AMD population response that we can show a similar benefit to other anti VEGF agents with a significantly reduced treatment burden that would be the goal.
Operator: Thank you. One moment for our next question. Our next question comes from Yi Chen with H.C. Wainwright. Your line is open.
Thank you one moment for our next question.
Our next question comes from E. Chen with H C. Wainwright Your line is open.
Sure.
Sure.
Operator: Thank you for taking my question. Could you provide us with your view on gene therapy being developed for WebMD, whether it could be a big competitor for six months and nine months sustained therapy for WebMD, and whether its application could be limited to the most severe patients? Thank you. Thanks, Yi. So gene therapy is certainly an exciting advance in the retina field, and as a replacement for a faulty gene, it's obviously been approved in that indication and has been an incredible benefit to patients. Using it as a drug delivery system also shows promise, especially for chronic diseases.
Thank you for taking my question could you provide us with your view gene therapy being developed for wet AMD, whether there could be a big competitor for six months or nine months for <unk>.
And whether their application could be limited to most severe patients. Thank you.
Thanks Heath, So gene therapy is certainly an exciting advance in the retina field.
And as a replacement for a faulty gene. It's obviously been approved in that indication and really has been an incredible benefit to patients using it as a drug delivery.
Also shows promise, especially for chronic diseases.
Jay S. Duker: The issues around wet AMD really have to do with, first of all, what appears to be a relatively narrow therapeutic window between efficacy and safety that gene therapies need to really thread. And secondly, the question about alternatives. Gene therapy is presumably going to be more expensive than current therapies or other therapies in development. And therefore, how does one, you know, either an individual retina specialist or payers or society in general justify the use of a more expensive type of treatment if it's not clearly superior to what's out there already?
The issues around wet AMD.
Really has to do with first of all the.
But it appears to be a relatively narrow.
Therapeutic window between efficacy and safety that the gene therapies need to really thread.
And secondly, the question about alternatives.
Gene therapy is.
Is presumably going to be more expensive than current therapies or other therapies in development and therefore.
How does one either an individual retina specialists or payers or society in general justified the use of more expensive type treatment. If it's not clearly superior to what's out there already so at a high level I think all retina specialists are excited about the promise of gene therapy.
Jay S. Duker: So at a high level, I think all retina specialists are excited about the promise of gene therapy, but in Wayne, in particular, there's a really tight needle that needs to be threaded. Thank you. And I'm showing no further questions at this time. Ladies and gentlemen, this does conclude your program. You may now disconnect. Everyone have a great day, everyone. GoodBye.
But in ways in particular, theres, a really tight needle that needs to be threat.
Thank you and I'm showing no further questions at this time, ladies and gentlemen, thank you for participating in today's conference. This does conclude your program. You may now disconnect everyone have a great day.
Everyone. Thanks.
Okay.
[music].
Okay.