Q3 2025 Ocular Therapeutix Inc Earnings Call
Good morning and welcome to the ocular therapeutix. Third quarter 2025 earnings conference call. At this time, all participants are in a listen-only mode.
After the prepared remarks, we will conduct a question and answer session to ask a question. Please press star 1.
As a reminder, this conference is being recorded and will be available for replay on the Investor Relations section of the Ocular Therapeutix website. I would now like to turn the call over to Ocular's Vice President of Investor Relations, William Slattery. Please go ahead, Mr. Slattery.
Good morning, everyone. And thank you for joining us today.
Earlier this morning, we issued a press release and filed our quarterly report on form. 10q outlining our financial results and business updates for the third quarter of 2025 along with several updates to our registration programs for xpax, also referred to as OTS tki in wet AMD and non-proliferative diabetic. Retinopathy
Ocular Therapeutix Executive Chairman, President, and CEO Dr. Pravin Dugel will summarize recent business highlights before we move to our question-and-answer session.
Joining Dr. Dugle for the Q&A, portion of the call will be Donald nman Chief Financial Officer and Chief Operating Officer Sanjay. Neach
Chief strategy officer and Steve Myers. Chief commercial officer.
For a comprehensive update of third quarter, 2025 financial and business results.
During today's call certain statements, we will be making constitute forward-looking statements under the Safe Harbor. Provisions of the private Securities, litigation Reform, Act of 1995,
Actual results May differ materially as a result of a variety of factors including risks and uncertainties identified in the risk factor section of our annual report on form 10K and our other SEC filings.
With that, I'd like to hand the call over to Dr. Pravin Dugel to review our recent updates.
Good morning everyone and thank you for joining us today at ocular therapeutix. We are courageous bold and opportunistic.
We make decisions from a position of confidence. We refuse to accept the status quo.
Not in how we develop drugs, not in how we design trials.
And not in how we think about the retina Market.
Our purpose is clear.
To redefine the retina experience for patients Physicians and payers around the world.
2025 has been a transformative year for ocular therapeutix.
We've Advanced 2, registrational studies in wet, AMD, so 1 and so large.
Each designed to answer distinct clinically relevant questions.
As our momentum continues, we are thrilled to announce today that Ocular Therapeutix has reached its target. Randomization of 555 subjects, an important milestone, reflects exceptional execution and strong investigator enthusiasm for Expands Lake.
In addition to Soul 1, and so large.
We designed a long-term extension trial solex.
Which goes well beyond simply providing long-term, safety data.
And may provide further evidence that exactly treatment should be started. Early to obtain the greatest visual benefits.
Equally important, we've unveiled our registrational Helios program in diabetic, retinopathy, which we believe represents the next Frontier.
In our mission to deliver long-lasting.
Clinically impactful and genuinely sustainable therapies for retinal diseases.
This is a bold initiative to pursue a single broad superiority label that captures the entire spectrum of diabetic retinal disease, including non-proliferative, diabetic, retinopathy npdr and diabetic macular edema DME.
With 2 complimentary strategically designed studies, Helios 2 and Helios 3.
We intend to address both populations within 1, un program.
If the Helios trials are successful, we expect that we would not need any additional studies to market exactly for the use of the spectrum of diabetic retinal disease.
At our recent investor day, I described how ocular is now positioned to redefine this field, through a strategic Triad.
Number 1.
The potential for a superiority label. That may set expects the apart from all other anti veg Fs in both wet AMD and diabetic retinal disease. Number 2.
Expanding the market to potentially capture the vast, untapped opportunity of wet, AMD and diabetic retinal disease. And number 3 potential for immediate adaptability
Made possible by a product profile that seamlessly integrates into today's retina practice.
Today, I'd like to elaborate on each of these pillars, how they Define our strategy guide, our execution and position ocular to lead a potential, generational shift in retinal therapy.
Let's start with superiority.
To date. No approved therapy in wet. AMD has demonstrated superiority to an anti veg f.
Each successive entry.
Has only been incrementally longer-lasting.
This has led to an increasingly commoditized landscape.
a market where differentiation has eroded and pricing pressures, have intensified
More recently biosimilars have turned? What was once a breakthrough in the field?
Into 1 defined by step therapy restrictions and Rapid discounting that encourages a pricing race to the bottom.
We Believe exactly as the potential to break this cycle.
So 1, our phase 3, superiority trial and wet. AMD was designed under a spa agreement. With the FDA and remains on track for Topline data in the first quarter of 2026.
If successful, we expect Ex-Taxi could be the first and only therapy with a superiority label.
Compared to a single dose of anti-vegf.
This superiority label extends Beyond wet. AMD
And now, we include diabetic retinopathy, where we will initiate two superiority trials: Helios 2 and Helios 3.
Achieving a superiority label would put us in a strong position.
In a category of 1.
Why does this matter?
Because a superiority label, not only defines a clinically differentiated asset.
But it also fundamentally changes market dynamics.
It can potentially insulate us from the pricing compression and formulary step therapy. That plagued me to agents.
When a product demonstrates superiority.
And is approved by the FDA.
It can become a premium drug.
Chosen first by the physician, not forced to be a later line option by the payer.
We believe this is the Holy Grail of retina.
Superior outcomes improved durability, and a pricing model that rewards innovation.
We are proud that both Soul 1 and Helios 2 in wet, AMD and NPD are respectively.
Are designed under formal FDA agreements and anchored in superiority endpoints.
These are not marketing terms.
They have substances statistically significant, meaning, as agreed by a regulatory body, this gives us a path to pursuing claims that no other company currently possesses.
The second pillar of our Triad is Market expansion.
Today.
The global annual antiva Market is estimated at roughly 15 billion dollars.
That figure tells only a fraction of the story.
It reflects patients who are currently treated. Not those who should be
In patients with AMD, up to 40% discontinue therapy within just the first year, often due to the burden of monthly or bi-monthly injections.
In diabetic. Retinopathy the situation is even more staggering fewer than 1% of the 6.4 million npdr patients in the US received treatment. Even though anti-vegf drugs have been shown to work in this indication.
The gap between what's possible.
And what’s practiced represents what we believe is the largest expansion opportunity in retinal medicine.
Our goal with exactly is not simply to compete for share within today's treated population.
But also to expand that population by reducing burden increasing adherence, and improving long-term outcomes.
We believe we can achieve this through 3 key drivers.
First durability.
Is designed to deliver sustained. Suppression of Vega for up to 12 months, following a single injection.
This could allow Physicians to see their patients less often while maintaining Disease Control.
Second flexibility.
Between 6 and 12 months, providing realworld adaptability across diverse heterogeneous, patient needs.
Third confidence.
Data from both soul and Helios programs combined with FDA aligned trial, designs, and are planned. Long-term open label extension and wet. AMD May provide the evidence base Physicians and payers need
To support early consistent use.
Even modest, improvements in adherence, could translate into hundreds of thousands of additional patients retaining vision and a market opportunity significantly larger than what is measured today.
At our investor day. We showed analyses demonstrating, how we plan to move the current treatment discontinuation spiral towards a treatment, retention cycle, with axially and wet AMD.
Expanding treatment into diabetic, retinal disease, accelerates that Market expansion, even further.
this includes npdr and disease 3 times as prevalent as wet AMD with no standard of care in use today and DME
This is not hypothetical incremental growth.
This is redefining the market.
The third pillar of our Triad.
Is the potential for immediate adaptability.
When we talk to retina specialist 1 theme is clear, workflow matters.
They want innovations that improve outcomes without requiring alterations to practice dynamics.
X-axis was designed precisely with that in mind.
It requires no surgery.
There is no need for concom and steroids and we believe no additional monitoring is needed.
Exactly will be administered by Retina Specialists who are familiar with intra vitual injections and perform these tasks every day with AA by bismo or lucentis
The Experience itself will also be familiar.
We are conducting all our registrational trials and expect to launch with a pre-filled injector.
Just like the pre-filled syringes used with most commercial anti-vegf injections today.
Moreover, the single hydrogel is designed to be fully bioresorbable intended to leave. No remnants behind without active drug.
The procedure and the post injection experience are similar to current anti-vegf injections, except that exactly could last up to 12 months.
This makes sense late. Not just innovative.
But also easily adaptable.
Patients may benefit from fewer visits and longer durability. Physicians benefit from a potentially better drug with the same workflow, and payers benefit from reduced utilization. This leads to predictability, fewer patient dropouts, and potentially better long-term outcomes.
X-pack can allow Retina Specialists to see more patients less frequently.
it can enable a more predictable schedule for patients and even if patients need to reschedule a visit,
there should be enough drug on board to cover them until they can get in to see their physician.
Ultimately, exactly, may help alleviate the burden that often leads to treatment discontinuation or problems with adherence.
The bottom line is that we believe exactly can simplify optimized and even scale, modern retinol practices.
And importantly, this view isn't just ours, it is shared by the stakeholders who matter. Most, when it comes to patient access and value,
Clinical strategy, study designs and endpoints.
We have been extraordinarily pleased with the feedback, we have gotten from these conversations.
On superiority.
1 payer describe the potential.
Of a product with xaxis expected durability as game changing.
While another noted that it could be, clinically preferred ahead of the entire anti vegf class.
On market expansion, one comment captured at best.
Avoiding blindness.
Is invaluable and less costly.
And on adaptability, another payer noted.
There is value in consistent, sustained, and uninterrupted therapy.
These conversations affirm what we already believe.
Payers can see the potential of the product with xaxis Target profile to deliver meaningful.
Clinical differentiation expand access.
And redefine value in retina by improving outcomes, while potentially reducing the overall burden of care.
Earning to our sole registrational program for expats late in wet AMD.
Our success to date is built on outstanding execution.
In Soul 1, I could not be more pleased with how the study is running, including retention trial conduct and safety monitoring.
As it relates to retention to date more than 95% of patients remain on the study.
That's almost every participant, staying engaged over the course of the study which is unheard of for retina trials.
As it relates to rescues today.
Per our Mass review, over 95% of rescue events.
Have met the pre-specified, protocol-defined criteria.
Let me repeat that.
Over 95%.
Of all rescue events have occurred exactly as designed.
That level of compliance under masking is exceptional.
Simply put patients are staying in the trial and Physicians are waiting until patients meet the predefined thresholds. Before administering rescue treatment in the vast majority of cases.
This speaks to the discipline.
Of our sights.
And the clarity of our protocol.
which is likely to yield a robust data set when we receive Topline data in the first quarter of 2026,
These Details Matter.
Protocol adherence, ensures that when we unmask data?
We will be looking at a clean reliable data set.
That can withstand the highest level of regulatory scrutiny.
Just as importantly,
The sole Phase 1 trials were overseen by an independent data and safety monitoring committee.
And there have been no safety signals today.
This is also worth repeating clearly.
There have been no safety signals to date as of served by an independent data, safety monitoring committee.
So our continues to progress in parallel with its 6-month screening and loading phase serving as an Innovative patient enrichment strategy designed to de-risk the study population.
So solar is the first trial of its kind to include an extensive 6-month screening and loading phase specifically designed to exclude patients with early persistent fluid or significant retinol fluid fluctuations which can otherwise introduce variability and disrupt non-inferiority trials.
I am thrilled to share this morning that solar has now reached its Target. Randomization of 555 subjects.
Significant milestone for ocular and reflects the remarkable speed and execution of our clinical team along with the overwhelming enthusiasm and engagement from investigators across the world.
The exceptional pace and scale of recruitment across the sole program underscore the strong demand among Retina Specialists and patience for more durable therapies, like expands sleep that can potentially deliver better long-term outcomes while reducing the treatment burden.
To maintain our commitment, to both patients and investigators, we will continue to allow randomization of previously, enrolled subjects, currently in the loading phase of the trial.
We continue to expect Topline data for so long in the first half of 2027.
And we will refine our guidance at the appropriate time.
Taken together. The sole program has been designed to generate a comprehensive efficacy and safety package. That addresses. The most important questions Retina Specialists will have giving them the confidence to use XP actually immediately upon launch if approved.
After subjects have completed 2-year, follow-up in either. So 1 or so are they will have an opportunity to enroll in our solex study for additional 3 years?
In this open label extension. All enrolled subjects will transition to every 6-month treatment with xpax to be clear. This study is a strategic initiative, not a regulatory requirement.
We believe so Lex could generate value insights into the potential long-term benefits of using a non-polar tile treatment. Like xaxi, in addition to providing long-term safety data,
The study is designed to assess key outcomes, such as vision preservation, anti-fibrotic activity, and most importantly,
The potential consequences of delaying, xactly treatment.
In the control. Arm patients.
So Lex outcomes May further expand please potential by highlighting the need to start expats treatment, early for risk worse. Long-term visual outcomes.
By reducing the treatment burden and potentially improving long-term outcomes. We believe the data from solex could increase, both short-term and long-term patient retention significantly.
Let's now turn to diabetic, retinal disease, which we Define as both.
Diabetic retinopathy and DME or diabetic macular edema.
Where our Innovation extends to how we think about Trial design, endpoints and label strategy.
Our Helios program represents a bold differentiated approach to this disease.
We are pursuing a broad diabetic, retinopathy label that also encompasses, DME a complication within the diabetic, retinopathy continuum.
We believe the strategy allows us to capture the full spectrum of diabetic eye disease with a single registration or program.
The unmet need here is staggering
Diabetic eye disease, affects more than 100 million people globally yet the majority remain undertreated.
Even among npdr patients without DME disease progression leads to irreversible vision loss if left unmanaged.
Current treatment paradigms are largely reactive waiting until Vision threatening complications occur prior to intervention.
We believe that must change.
Our Helios 2 and Helios 3 Phase 3 trials are designed as superiority studies to demonstrate that early, infrequent treatment with Exactly can meaningfully alter the course of disease.
And scientific rigor.
Together. These 2 trials will evaluate 6 and 12 month dosing intervals. Providing flexibility to address diverse patient needs.
A key innovation in these studies is our primary endpoint, an ordinal 2-Step, drss endpoint at week 52.
Historically, phase 3, Dr. Trials have, relied on binary diabetic retinopathy severity score or drss endpoints counting only the percentage of patients who achieve a greater than or equal to 2-Step Improvement, or those who achieve a greater than or equal to 2-Step worsening. Not both
While straightforward, this method discards valuable clinically relevant data.
Our ordinal analysis by contrast captures the entire spectrum of patient responses, Improvement, stability, and worsening allowing every participant to contribute data to the statistical analysis.
This approach offers several distinct advantages. It reflects real world treatment goals.
To both improve disease and prevent worsening.
It increases statistical power ring, allowing more efficient studies with a smaller sample size,
It potentially provides a higher probability of success compared to other endpoints considered.
And it aligns fully with FDA guidance as confirmed in our spa for Helios 2.
We evaluated other endpoints such as Vision, threatening, complications, or vtcs.
But those present major limitations btc's are binary and event-driven, which require much larger sample sizes and longer durations to reach statistical power.
They also reflect late stage disease progression rather than early therapeutic benefit.
In short, ordinal DRSS is not only more clinically relevant, but it also has a potentially higher probability of success.
But it is also agreed to with the FDA from a regular Torii standpoint.
The right endpoint to demonstrate exact disease modifying potential in Dr. Pravin Dugel.
Since announcing this endpoint. At our investor day the feedback from both investigators and the broader retina Community has been outstanding.
We believe this approach represents the future of diabetic, retinopathy trial design.
And we expect this ordinal endpoint will become the new gold standard for the field moving forward.
Unlike our wet AMD program, the Helios 3 trial, employees, sham injections, and there are important regulatory reasons for that distinction.
Dr. Trials
have very different regulatory requirements compared to the 2023 FDA draft guidance for wet AMD.
Shams should not be used in wet, AMD or even in central involving DME studies because they require subjective. Visual Acuity. Primary endpoints. Where sham injections may not provide adequate masking and could influence outcomes.
Ndr however outcomes are based on objective, retinol, photographs, not subjective, patient responses.
Moreover, since there is no Universal standard of care for npdr.
Sham control is not only acceptable but necessary to ensure Global regulatory alignment particularly in countries without approved therapies for this population.
Finally.
Our design strategy enables us to pursue a single unified. VR label that encompasses, both npdr and DME.
Because DME is a complication affecting a subset of Dr. Patients
All patients with DME inherently have underlying retinopathy.
In Helios 2 and Helios 3, we plan to include patients with non-enterprise.
Subjects with non-central involvement, DME demonstrated improvement with Xaxi in our Helios Phase 1 study.
Approach eliminates the need for separate DME, trials and may position us to address the full diabetic. Eye disease Spectrum with a single registration or program.
By focusing on a superiority driven, Dr. Label, that captures the entire Continuum of disease, We Believe exactly can unlock a market opportunity, that is not just incremental.
But transformative for patients, Physicians and payers worldwide.
We ended the third quarter of 2025 with approximately 345 million dollars.
in cash, which does not reflect approximately 445 million in net proceeds from our October Equity financing,
we were thrilled to see the enthusiasm for participation in our recent financing validating the Bold opportunistic decisions we have made to date.
Every decision that is made in this company, is made from a position of confidence in our drug expatiate. And in our clinical strategy,
and in our Market potential,
our confidence is compounded by consistently positive feedback, we are hearing externally, including from payers who represent the vast majority of covered lines in the US.
These discussions have reinforced, the excitement we have seen from investors.
And further validated our Triad based strategy.
These perspectives underscore that the market is already preparing for a future potential defined by taxi.
1 where potentially better outcomes, lower burden and cost efficiency converge.
Following our recent financing. We are now in an enviable position with an expected cash Runway into 2028 and the financial flexibility for
Topline data from both soul and Helios registrational programs.
Advanced solex our long-term extension trial.
Invest in manufacturing capacity and infrastructure and prepare for commercial launch and Global expansion in anticipation of a potential xaxi approval.
We are operating from a position of increased strength.
Every Capital decision we make is proactive, not reactive made from conviction not constraint.
when you put it all together,
our science, our trial design, our execution,
and our strategic vision.
The path forward is clear.
We are building ocular therapeutix around the Triad that defines how we intend to redefine the retina experience.
Potential superiority, label.
Setting a new standard of durability that transcends incremental. Improvements creating lasting competitive differentiation and potential insulation from pricing and step therapy pressures.
Market expansion.
Transforming a 15 billion dollar treated Market into a much larger addressable Opportunity by reducing burden, improving adherence, and reaching millions of untreated patients with wet, AMD, and Dr.
Immediate adaptability.
Delivering a product that fits seamlessly into existing practice.
No surgery. No concom steroids.
No change in workflow.
Simply a better longer lasting treatment that aligns with how Retina Specialists already work.
This Triad isn't a marketing pitch.
It's the blueprint of how we intend to redefine retina.
Period.
To summarize, today's key points number 1.
Soul 1 remains on track for Topline data in the first quarter of 2026.
With exceptional retention and trial integrity.
On the expats label and what AMD?
Number 2.
Solar has. Now reached its Target. Randomization of 555 subjects.
and is rapidly progressing toward Topline data in the first half of 2027,
Built on a real world design with a de-risking. Patient, enrichment, strategy.
Number 3.
Our Helios program will initiate imminently.
Leveraging a novel ordinal endpoint established.
Per the spa agreement for Helios to, with the FDA.
We believe this is the optimal endpoint that increases statistical power and provides us a greater probability of success compared to other end points.
Number 4.
we continue to pursue a broad diabetic retinal disease label including DME that could significantly expand exactly to reach
Number 5.
Our financial strength gives us the flexibility to obtain Topline data from each of our solar 1, solar and Helios programs. Pursue our solex open label extension study.
And prepare for commercialization with confidence.
Number 6.
and finally,
through the Triad of superiority.
Market expansion and immediate adaptability
We're building a company positioned, not just to participate in the retina Market.
But to redefine it.
At ocular therapeutix.
We are bold in our science.
Courageous in our strategy.
And relentless.
In our pursuit of Excellence.
Thank you for your time and your continued support.
Operator.
We are now ready to take questions.
Thank you. We will now be conducting a question and answer session.
If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2. If you would like to remove your question from the queue,
For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.
We ask that analysts limit themselves to 1 question, so that others have an opportunity to do so as well. 1 moment, please while we pull for questions,
our first question comes from,
Tazeen Ahmed with Bank of America, please proceed with your question.
Good morning. Uh thank you for taking my question and um thanks for the very detailed update and maybe um wanted to get a sense of how you're thinking the initial label for what AMD could look like because you're doing a lot of work you know among still 1 still are and so X.
So what would be the initial label look like and what do you think would be attributes of a label that you would think would be competitive that may need to be added on later? As more data comes in. Thanks.
Thank you to Zen and and good morning. Uh, thanks for the question, a very appropriate. Great question. And uh I'll start out by saying of course we're not in labeling discussions with the FDA as yet but you can see that this company has strategically placed the clinical trials in such a way as to get we believe the best label uh in the history of our field. We expect our label to be a superiority label based on soul 1, uh we believe it will have the flexibility of dosing every 6 months.
To every 12 months based on solar. And so 1. And it will also have flexibility obviously of repeat dosing.
That's what we expect from initial label. Again, we're not in discussions with the FDA as you can imagine. Um, however, the other thing also that I'd like to note is that, although, this will not be in the label. Remember that in the masking arm of soar? Uh, we are going up against high dose Isaiah. So, although the randomization is 22 and 1, and although this is not for statistical analysis, we certainly will have the numeric data, so we believe that we'll have a great competitive Advantage versus the second generation of anti veggies with high dose IA as well. Kazin, thank you again for the question.
Our next question comes from Tara bencraft with TD Cohen, please proceed with your question.
Hi, good morning. So my question is on an npdr. So 1 really quickly for the expected patient populations in the Helios trials. Can you tell us what percentage of the enrolled um, that you would expect to have that are non Center involved, DME? And then, uh, the real question is, um, if you could maybe describe in a little more detail for us, what is it that underlies? Your confidence in having a, a very broad DME inclusive, label Beyond, um, only the non Center involved, um, especially compared to a different approach, you know, of running separate, DME, trials, altogether, because, you know, in that I think it would be helpful if you could also discuss, you know, whether the inverse could be true. That successful DME trials, could be inclusive of npdr at all or not. Thanks,
Tara, good morning, and thank you for the question. Great question again. So, as far as the first question is, is concerned really a quick answer? The the fact of it is that we don't know, and when the time is appropriate, we certainly will guide you as to the stratification of our Baseline patients. That we have enrolled in regards to the second question. The first thing to to look at, is the the data from the Helios 1 Study, um, recall that with a single injection of x, paxley a single injection, at week, 48, every single pair.
Patient with non Central involving diabetic, macular edema improved. Again, every single patient with diabetic, macular edema improved with a single injection. We've looked at these patients in every which way that was presented in our investor day. Including in terms of total volume, etc, etc. And Peter Kaiser, showed you every single patient and every single patient. With a single injection, improved on the other hand, every single patient who was not treated in the control, group got worse. So we have great confidence based on the Helix 1 data that patients with non- Central involving diabetic macular demo will improve. Now again, we're not enabling discussions obviously with the FDA but what I can tell you is that historically, the FDA has given label based on the disease itself. If you recall in my last company with iveric bio, we studied only patients with extra foval Geographic. Atrophy, there wasn't a
Single patient that we studied with Central involving Geographic atrophy. And yet when you see the label of that drug, you will see that? It's a broad label encompassing all of geographic, atrophy. The same can be said of previous studies for diabetic. Retinopathy uh such as Panorama, the same thing could be said for visual limitations and clinical trials that have not extended to the label such as going all the way going back to Anchor and Marina. So we have great confidence that we will have a broad label.
Encompass all of diabetic eye disease, and we will not need to do another study for diabetic macular edema recall. Also, it doesn't work the other way around because every single patient with diabetic macular edema will have diabetic retinopathy, but not every single patient with diabetic retinopathy will have diabetic macular edema. So again, we have great confidence that we will never need to do another diabetic eye disease trial again for retina. We believe that we will obtain a broad label that will encompass not only diabetic retinopathy but all of diabetic macular edema. Thank you, Tara, for that question.
Thanks so much. Yeah, that's fantastic. Proxy to iveric. That's very helpful. Thanks so much.
Buen, are you there?
Yes.
Can you guys hear me?
Yes, please go ahead with your question.
All right, thanks for taking my questions. Um, maybe purvine on. Um,
The solar study, could you just talk about? You know, what percentage of patients were randomized from the screening phase?
And you know for solex um I understand you know on the open label extension.
You're going to enroll patients from uh Soul 1. But is our, you know, our solar patients also going to be eligible to participate. In Soul ex thanks.
So, as far as solar is concerned, a recall that what we have as a very thoughtful and long ramp. Um, recall also that if you look at every single study that has ever been done with an anti vgf where there would be lucentis, Isaiah avastin be of you, anything, what you see is a curve when you plot the visual Acuity. With the number of injection that looks identical which is that after 2 injections the visual Acuity improves and then it stabilizes. Now, what we could have done is simply to say after 2 or 3 injections will go ahead and randomize patients. And so are because we'll have a certain degree of confidence in regards to the stability, we didn't do that. We went way above and beyond what we did was to say, okay, we will do 3 loading Doses and we'll have a unique period to Observation periods. Not 1 but 2 in order to weed out any patient who would be unstable with any fluctuations uh in the oct of 35 microns or greater and
And and after that, we went ahead and gave 2 more loading Doses and only then do we randomize. So it's a very long ramp um, as far as the screen failures are concerned there and but that, that was your question, we haven't guided you to that as yet. Uh, we will when the time is appropriate in terms of, um, giving you the Baseline details. But as of yet, I'm just absolutely thrilled to report as we did this morning that we reached our Target randomization of 555 patients. Uh, this is a credit not only to our clinical
Team, which has been just absolutely outstanding in terms of execution throughout this entire process with sold on with solar and you will see very soon with The Helio studies, but it's also a credit to the patients, and to the piss. Uh, and we're incredibly grateful to both that. We've reached this point of the Target. Randomization in regards to the open label study, uh, both studies. Sold 1 and solar will funnel patients into the open label extension again. We'll have a lot of data that we will have in that open label extension. I think 1 of the most important things that we will have uh is what the crossover patients will do. Now, remember the crossover patients will cross over after 2 years of pulsatile therapy. We don't believe that those patients will ever catch up. And the reason for that is that we know that fibrosis can be detected as early as 90 days after pulsatile therapy.
And we believe that with 2 years of pulsatile therapy that will limit the patient's vision improvement and we will have data showing that for the best long-term outcomes. It is necessary to start. Exactly from the very beginning. Uh we believe that data will be very important. The other part related to this also is that in all studies starting with the 7 Up study for instance long-term outcome has shown a gradual decline in visual Acuity based on
Gnosis and atrophy. And we believe that with constant suppression that exactly will provide, we will see continued visual Acuity Improvement in stabilization, which will also add to the long-term outcomes that we will benefit from immediate treatment with actually and continuation of exactly with long-term constant, suppression of vegf. Thank you, Barren for your question.
Our next question comes from Colleen, koozie with beard. Please proceed with your question.
Great. Good morning. Thanks for taking our questions and congrats on all the progress. Uh, just as we're getting still a little bit closer. Now, to the sole 1 data, um, just what details would you expect to share in the stolen 1? Top Line specifically, would you include 6 month bcva and what do you think will be the most important data points from Soul 1? That will help give us confidence in the read through to solar. Thank you.
Yeah, good morning. Uh Colleen and and thank you for your question, a great question, which I'm sure is on everybody's mind. Here's what I would say. Look what we have done and what we have said is that we are very strategic in terms of planning these studies and our expectations of what the goal of these studies are
You as yet but we certainly understand what we need to do with the card. Turn in terms of The Narrative of a positive Soul loan study but let me also say that. Why will why we will provide you even more confidence. In the success of solar? There should already be a great deal of confidence that solar will succeed based on several factors. First, is the de-risked patient randomization that I've already spoken to, which has really the longest ramp, the most thoughtful de-risking that I've ever seen of any study. And the second 1 is pertaining to the trial. Design is the end point. It's a 56 week endpoint. It's a singular endpoint that we believe is absolutely optimal for us again.
It's a singular 56 week endpoint but to summarize choline what I would say is we understand the challenge. We will absolutely need the challenge. We will provide you even more confidence based on the sole 1 card turn that there will be a positive solar study. Thank you for your question.
Helpful. Thank you.
Our next question comes from s.
Sean McCutchen with the Raymond James, please, proceed with your question.
Hey guys, thanks for the question. Um, give me a quick 1 for me. Can you speak to the progress of getting the npdr studies up and running know you're using a similar site for footprint to the wet A&B program? You know, how do you anticipate that accelerating those studies? Bye.
Sean, good morning and thank you for the question. Um, you know, look the the uh, the process started immediately after the raise for npdr. Um, we're very fortunate uh, that we have sent haste sites all over the world. Um, you can you've seen the results of that based on the execution of Soul 1 and solar and yes, and many of you have the same sites uh, are being used. There are additional sites as well. Uh, the the we are very, very fortunate that we have people in this company. As you as, you know, with an enormous amount of expertise. Uh, many of the folks here have have trained, many of the people, uh, that run these sites, and certainly know pretty much everybody around the world. So we're in an envious position of being able to strategically, pick the very best sites, um, and you've seen that again, you know. Look it's easy to forget where we were Sean, not long ago. We had a trial that everybody said, was not recruitable. We recruited way ahead of schedule in record time and
And then people said, well, even if you did recruit that trial, there's no way that that's the execution is going to be good, doctors are going to do whatever they want. Patients aren't going to stay we've provided you data in a in in our investor day and today real numbers to show you how well the execution is taking place that 95 we have a 95% um on protocol rate over 95% on protocol rate and over a 95% retention rate. Those things are absolutely unheard of for any trial and error, let alone a trial that supposedly was impossible to recruit. And often times we forget that we forget the level of execution that this this team has has provided. And that's not only thanks to the clinical team. But that's also thanks to the site sites that they've selected and the personal relationship that all of the team has with not only the Pia, but the entire the entire site. So the answer to your question is, we will give you guidance to the Helios progression. We're very pleased.
With the way that it's going. Um, and you'll hear more details to follow. Thank you Sean for the question.
Our next question comes from John Wooden with citizens, jmpp. Please proceed with your question.
Hi, this is Katherine on for John. I just have another quick 1 for the Dr. Program, I'm just wondering if there's any risks associated with using the ordinate 2-Step drss endpoint especially um since you're considering using a smaller patient population. Is there any concerns regarding a higher placebo effect given that kind of patient variability and wonder if you could speak to that? And how do these risks compared to a traditional endpoint?
Rug that we have given the data that we have. We are very confident that with the ordinal endpoint that we will succeed. Um, again if you look back at the Helios 1 Study, what I would say, as a clinician who's practiced for over 30 years. And also, with all the other clinicians that we have in this company, is that we've really never seen a situation where a single injection of a drug again, a single injection of a drug after week 48, has results where every single parameter is in favor of the drug. And remember, this was just the drug, this was not a combination of agent IA, wasn't combined with this. This was simply exactly and nothing else completely transparent. And what you will see, there is not only in terms of the diabetic, retinopathy score, but also in terms of diabetic macular edema, and then we've looked at an every single, which way possible, including total fluid volume, including profusion, and every single parameter face.
Favored. The drug with a single injection after week 48. So we have great confidence in the endpoint and we have great confidence in the success of both, Helios 2 and Helios 3. And remember also that Helios 2 uh, has an FDA approved Spa, um, going with it as well to validate that study and validate the study design. Again, I also want to repeat that both Helios to and Helios 3 are superiority studies. Katherine again, thank you for the question.
Thank you.
Our next question comes from yichen with HC Wayne Wright please. Proceed with your question.
Good morning, and thank you. Take for taking my question, uh, for the videos to trial once started, how long do you think it will take to complete enrollment of 422 patients? Do you think, uh, MPD or patients would be uh relatively difficult to enroll? Because they are reluctant to get treatment in the first place.
You, thank you for your question and good morning to you. Um, so, you know, we have already seen a great deal of inertia to enroll these patients. In fact, we saw that before we even announced the trials, um, as as as I was asked earlier on by John, whether we're using the same sites or not. I said, yes, there was a great deal of overlap including other sites, the sites have already have already been demanding for this demanding, the study there is such a need out there for these patients. Uh, and remember what we're what we're enrolling is, we're enrolling Advanced, uh, severe, uh, moderate to Advanced the non-proliferative, diabetic retinopathy. So, a lot of these patients are symptomatic, they may not have lost Vision, but they certainly have blurry vision, Etc. They certainly are knowledgeable that there are, uh, there there's a threat to their Vision. So there's a great deal of, um, of of
Need out there in a great deal of enthusiasm to have something that is absolutely sustainable. Both by both patients as well as uh, the piss. Um and this is completely sustainable. As you know, it's a single injection if it if it does what we expect it to do that will last uh, for a year. Um, this is we know that this is a target that's de-risked that's validated in other studies. Uh, so we believe that this is a relatively uh, de-risked study and especially given what I just said about Helios 1. We're very, very confident in the results. So to answer your question, we don't think that there's going to be any issue whatsoever. Uh in in completing these trials in a very efficient manner. This is already underway and we will uh guide you when appropriate again, thank you for the question.
We've reached the end of our question and answer session. There are no further questions at this time. I would now like to turn the floor back over to Dr. Dugo for closing comments.
Thank you very much. Um, I, I'd like to thank all of you, uh, for your time today. I'd like to thank all of you for your diligence, and for joining us. Uh, we look forward to, um, updating you on our progress. If you have any follow-up questions whatsoever. Please reach out to Bill Slattery or vice president of investor relations and have a great day. Everybody. And thank you again for your time.
This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.