Earnings call transcript: Ocular Therapeutix misses Q2 2025 earnings, stock drops

Ocular Therapeutix Inc. reported a disappointing second quarter for 2025, with earnings per share (EPS) at -$0.39, missing the forecast of -$0.35. Revenue also fell short, coming in at $13.46 million against a projected $13.56 million. Following the earnings release, the company’s stock dropped by 5.14% and continued to decline in pre-market trading, falling an additional 8.74% to $11.27. According to InvestingPro analysis, the stock is currently trading above its Fair Value, with the RSI suggesting overbought conditions despite impressive year-to-date returns of 44.61%.

Key Takeaways

• Ocular Therapeutix missed both EPS and revenue expectations for Q2 2025.
• The company’s stock price saw a significant decline post-earnings announcement.
• Strong cash reserves extend the company’s financial runway into 2028.
• Promising developments in the pipeline, especially in wet AMD treatment.
• Market sentiment remains cautious due to financial performance concerns.

Company Performance

Ocular Therapeutix’s performance in Q2 2025 was marked by a notable earnings miss, which deviates from the company’s previous trajectory of closely meeting expectations. With a market capitalization of $1.88 billion and concerning gross profit margins of -160.4%, the financial results have raised concerns about its ability to manage costs associated with ongoing and future clinical trials. However, InvestingPro data shows the company maintains a healthy current ratio of 10.22, indicating strong short-term liquidity. The broader industry context shows a competitive landscape in the wet AMD market, where Ocular Therapeutix aims to differentiate itself with innovative treatments.

Financial Highlights

• Revenue: $13.46 million, below the forecast of $13.56 million.
• Earnings per share: -$0.39, missing the forecast of -$0.35.
• Cash and cash equivalents: Over $390 million.

Earnings vs. Forecast

Ocular Therapeutix’s EPS of -$0.39 represented an 11.43% negative surprise from the forecasted -$0.35. Revenue also missed by 0.74%, which, while relatively minor, contributed to the overall negative market sentiment.

Market Reaction

Following the earnings announcement, Ocular Therapeutix’s stock price fell by 5.14%, with further declines in pre-market trading. The stock, which was trading at a 52-week high of $12.35, dropped to $11.27, reflecting investor concerns over the earnings miss and future financial outlook.

Outlook & Guidance

The company remains optimistic about its pipeline, particularly the potential of its expaxly product for wet AMD. With analyst price targets ranging from $14 to $22, market expectations remain high despite current challenges. Ocular Therapeutix plans to host an Investor Day on September 30, 2025, to provide further insights into its strategic initiatives and clinical trial progress.

Executive Commentary

Dr. Praveen Dugel, CEO of Ocular Therapeutix, emphasized the potential of their expaxly product, stating, "If approved, we believe Expaxly has the potential to be the first product for wet AMD with a superiority label." He also highlighted the company’s broader vision: "We’re not just developing a drug. We’re redefining the retina experience with confidence, clarity, and conviction."

Risks and Challenges

• The financial impact of ongoing and planned clinical trials remains uncertain.
• Market competition in the wet AMD space is intense, with several established players.
• Potential delays in clinical trial results could impact the timeline for product launches.
• Macroeconomic conditions may affect funding and investment opportunities.

Q&A

During the earnings call, analysts focused on the modifications to the SOLAR trial’s rescue criteria and sought clarity on the company’s confidence in achieving a superiority label for expaxly. Ocular Therapeutix addressed these concerns by emphasizing the robustness of their trial designs and the potential market impact of their innovative treatments.

Full transcript - Ocular Therapeutix Inc (OCUL) Q2 2025:

Conference Operator: Good morning, and welcome to the Ocular Therapeutix Second Quarter twenty twenty five 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. As a reminder, this conference call is being recorded and will be available for replay on the Investor Relations section of the Ocular Therapeutic’s website. I would now like to turn the call over to Ocular’s Vice President of Investor Relations, Bill Slattery, Jr.

Please go ahead, Mr. Slattery.

Bill Slattery, Jr., Vice President of Investor Relations, Ocular Therapeutix: 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 10 Q outlining our financial results and business updates for the 2025, along with several updates to our registrational program for expaxly and wet AMD. Ocular’s Executive Chairman, President and CEO, Doctor. Praveen Dugel, will summarize recent business highlights before we move to our question and answer session. Joining Doctor.

Dugal for the Q and A portion of the call will be Donald Knottman, Chief Financial Officer and Chief Operating Officer Sanjay Nayak, Chief Strategy Officer and Steve Myers, Chief Commercial Officer. We refer everyone to this morning’s press release and our Form 10 Q for a comprehensive update of second quarter twenty twenty five 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 risk factors, including risks and uncertainties identified in the Risk Factors section of our annual report on Form 10 ks and our other SEC filings. With that, I’d like to hand the call over to Doctor.

Praveen Dugel to review our recent updates. Praveen?

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Morning, everyone, and thank you for joining us today. 2025 is shaping up to be a defining year for Ocular Therapeutix. As we look back on the progress made over the first half of the year, I’m proud to say we are continuing to execute with precision, speed, and scientific integrity. Last month, we updated our corporate branding to reflect who we are today, a company advancing with purpose backed by the momentum of our SOLE trials, and fueled by our unwavering commitment to patients. These changes represent more than a new look.

They mark the next chapter in our evolution as a retina focused company at the forefront of innovation. Our mission remains unchanged, to redefine the retina experience in hopes of preserving vision for the long term. For millions of patients around the world, wet AMD remains a relentless progressive disease. Despite recent advances in therapy, the burden of frequent injections remains unmanageable for many, with nearly forty percent of patients in The US discontinuing treatment within the first year. This is unacceptable to us.

And it’s exactly why we’re advancing expaxly, a treatment designed to offer best in class durability, meaningful efficacy, and real world flexibility. Our registrational program for expaxially includes the SOLO-one and SOLO-one studies. These are thoughtfully crafted complementary trials with bespoke patient populations designed to derisk outcomes and answer key questions physicians will have on the durability, flexibility, and repeatability of ex Paxley. If approved, we believe ex Paxley has the potential to be the first product for wet AMD with a superiority claim based on the SOUL-one trial. This trial is designed in alignment with the FDA’s guidance for conducting a superiority study, which has enabled us to secure a Special Protocol Assessment, or SPA, SPA agreement for SOUL-one.

Recently approved anti VEGF products and current competitive Phase III wet AMD trials are all based on non inferiority to aflibercept two milligrams. To our knowledge, SOUL-one is the only Phase III superiority trial being conducted in wet AMD. And if we’re successful in gaining FDA approval, we will potentially be the only wet AMD product with a superiority claim in the label for the foreseeable future. Combined with our non inferiority trial, SOLAR, we believe ex Paxley has the potential to unlock unprecedented durability with dosing of at least six months and potentially as infrequently as every twelve months. We believe this dynamic will allow us a unique and potentially dominant position compared to all other products in the commercial landscape, and could enable an opportunity that spans millions of patients worldwide, addressing the critical needs for a more sustainable, less burdensome treatment with improved long term outcomes.

This morning, we’re excited to share several updates across our SOLA-one and SOLAAR programs, including initial plans to incorporate a single long term open label extension study for both SOLAL trials, and updates to our rescue criteria for SOLAAR. These updates are designed to further enhance expaxly’s commercial profile and underscore the confidence we have in this program. We’ll also provide a financial update that highlights the flexibility optionality we’ve secured as we approach the SOLO-one top line data readout in the 2026. Continue to advance our manufacturing and commercial infrastructure, and evaluate expansion opportunities for expaxially in non proliferative diabetic retinopathy and diabetic macular edema. Finally, we are pleased to announce that we will be hosting an Investor Day on September 30 in New York City, which we encourage everyone to join, either virtually or in person.

Let’s first discuss our SOUL studies. I am pleased to report that both SOUL-one and SOLAR trials continue to move forward expeditiously. Trial conduct has been exemplary, and retention across both studies continues to exceed our expectations, underscoring the strength of our sites, the commitment of our investigators, and the quality of our operational planning. Let me start with SOLO-one, our superiority trial for ex PASLA. Following the successful randomization of three forty four patients in December 2024, the trial has maintained exceptional retention as we prepare for top line data in the 2026.

As part of the ordinary course of our trial monitoring, we periodically review rescue data on a mass basis. And what we look at are primarily three things. First, the number of rescues. We need patients to be rescued to demonstrate a difference between aflibercept and ex Paxil. Second, the cadence of rescues, whether they occur in a distribution that is consistent with our hypothesis as to how aflibercept patients would behave and how expaxially patients would behave.

And third, whether the rescues are on protocol or not, as this goes to trial conduct and the reliability of data we are generating. I am pleased to share that the vast majority of rescue events remain fully aligned with the pre specified criteria outlined in the SOLA-one protocol. Simply put, patients are staying in the trial, and physicians are waiting until patients meet the predefined threshold of a 15 letter loss in visual acuity from baseline before administering rescue treatment in the vast majority of cases. That’s not just a procedural win. It’s also a powerful testament to the integrity and reliability of the data we are building.

And this reinforces our confidence in the quality of the data set we intend to deliver to the FDA. And when we step back and look at the number and cadence of rescues, again under masking, we’re also thrilled with what we’re seeing. This is based on our expectations of the difference in how the two agents would perform over time. We look forward to hopefully confirming that hypothesis once we are able to unmask the study in Q1 of next year and report top line data. We are also excited to announce plans to incorporate a long term open label extension study for both SOLA-one and SOLA-one, which patients will be eligible to enter following the completion of the two year safety follow-up period in each trial.

This extension study is a strategic initiative, not a regulatory requirement. We believe it will generate valuable real world insights into the potential long term benefits of using a non pulsatile treatment like expaxly, in addition to providing long term safety data. The study is designed to assess key outcomes such as vision preservation, anti fibrotic activity, and the potential consequences of delaying ex Paxley treatment in control arm patients. Our hypothesis is straightforward. If non pulsatile dosing reduces the risk of fibrosis and atrophy, the ex Paxley arm patients will have the potential for better long term visual outcomes than the control arm patients who have a two year delay before they initiate ex Paxley treatment.

Importantly, we expect this extension study will have significant commercial implications. In today’s evolving landscape, retina specialists and payers alike are seeking long term data that validates durability. We believe this study will enhance confidence in expaxly’s sustained performance and support broader adoption upon launch. We’re extremely excited to take on this effort as part of our commitment to delivering a long lasting, flexible, and non pulsatile solution that could potentially deliver improved long term visual outcomes on a treatment regimen that is sustainable for patients, caregivers, and physicians. Turning now to SOLAR, our non inferiority trial comparing expaxly dosed every twenty four weeks to aflibercept dosed every eight weeks.

We continue to advance this study with strong momentum and unwavering conviction in both our strategy and execution. This trial was deliberately designed with a six month screening and loading ramp to identify and exclude patients who demonstrate unstable anatomy, particularly those with high fluctuations in central subfield thickness. These are precisely the patients who could introduce variability and compromise outcomes in a non inferiority trial. Excluding them is a strategic choice, because a failed trial due to noise is not a risk we’re willing to take. With enrollment complete in SOLAR, we expect to have top line data in the 2027.

And we believe the structure of this trial gives us key advantages needed to succeed by de risking the patient population. The primary endpoint for SOLAR is to demonstrate non inferiority in the mean change in best corrected visual acuity at week fifty six, which is a highly favorable time point. It falls two months after both the last ex Paxley dose and the correspondent aflibercept injection for the control arm. Importantly, this endpoint is at a singular time point. It is not blended over multiple visits.

Separately, as part of our ongoing effort to ensure SOLAR reflects real world clinical decision making, we’ve streamlined and simplified the rescue criteria. The rescue criteria in SOLAR is now based on a greater than five letter loss in visual acuity, plus a greater than or equal to 75 micron increase in central subfield thickness. This change aligns the trial more closely with how physicians determine when to intervene in the real world, and simplifies the criteria for investigators to reflect their everyday clinical practice. This also reflects our confidence in ex Paxley based on what we are seeing under masking in SOLA-one. This is critically important, so let me reiterate.

The change in SOLAR rescue criteria reflects a thoughtful and proactive effort to further bridge the gap between clinical trial design and clinical practice. This is not an FDA requirement, but rather a strategic decision we have made from a position of confidence in expaxly’s ability to deliver meaningful outcomes in a trial setting that is more clinically relevant for physicians. SOLAR remains robustly powered at 90% to meet the non inferiority margin of minus 4.5 letters at week 56, based on our written FDA feedback and alignment. Let me step back a moment. In just over one year, we have built a world class team, advanced a groundbreaking program in wet AMD, And we enrolled and advanced two complementary registrational trials for expaxially, all the while maintaining excellent quality, speed, and operational precision.

From inception, these trials were intentionally designed to be complementary, not redundant. Each addressing distinct yet synergistic clinical questions that together form the foundation of our registrational strategy for ex Paxlo. SOLA-one is focused on durability with redosing after the nine month primary endpoint at weeks fifty two and seventy six. ZOLAR is focused on repeatability of ex Paxley every six months and real world applicability. Our clinical design strategy for both trials leverages a rigorous screening and loading phase to select bespoke de risked patient populations for randomization.

This is a critical differentiator, and one that we believe could meaningfully reduce patient variability in each trial and strengthen the probability of success in both trials. Together, these trials seek to address the most important questions physicians and patients will have about axpaxil’s durability, repeatability, and flexibility. If successful, these trials may support an unprecedented and potentially the first and only superiority label in retina that enables dosing every six to twelve months in a chronic disease where most patients currently require monthly or bimonthly treatment. Perhaps most importantly, both trials are built on the foundation of FDA alignment, with clear guidance around endpoints and trial design. And neither study uses sham comparators, consistent with FDA’s stated preference to avoid introducing bias in MAST studies.

This has been clearly stated in the FDA’s guidelines, which they have reiterated in person and in writing numerous times. This thoughtful, strategic design gives us confidence not only in our clinical program, but also in our ability to bring forward a product that redefines what’s possible in retinal disease. Pending successful outcomes, we plan to submit our NDA shortly after the SOLAR fifty six week primary endpoint. This strategy allows us to deliver a comprehensive package to the FDA that intends to address durability, repeatability, flexibility, and safety of expaxly. Notably, because exitabine is already FDA approved for non ophthalmic indications, we plan to leverage the five zero five(two) NDA review pathway, which has the potential to shorten the review timeline for expaxillary by two months compared to the traditional review pathway for new molecular entities.

Moreover, both trials have been designed in close alignment with the latest FDA guidance, SOLA-one under a SPA agreement, and SOLA-one informed by written formal feedback. With a strong clinical and regulatory foundation in place for wet AMD, we’re now preparing to expand our reach towards the next horizon, diabetic eye disease. Earlier this year, we received positive FDA feedback on our proposed trial design for patients with diabetic retinopathy. The unmet need here is immense. Despite available therapies, fewer than one percent of NPDR patients are treated.

And yet, with expaxially, we may be able to offer a long acting solution that reduces the risk of progression with just one or two treatments per year. Recall that in our HELIOS study, zero patients developed a vision threatening complication with a single injection of Axpaxly at forty eight weeks, compared to almost forty percent in the control arm. Additionally, all patients in the ex Paxley arm that had diabetic macular edema saw improvement at week forty eight. Although these results are from a relatively small Phase one study, we believe this is an area where Expaxly’s profile could drive real change, not just in patient outcomes, but also in how retina specialists approach disease prevention. We look forward to sharing more details about our NPDR and DME strategy at our upcoming Investor Day, which will be held on September 30 in New York City with virtual access available.

This will be an important event. We’ll walk through how SOLE trials work together to support what we expect will be a differentiated ex PASI label in wet AMD. We’ll share new insights on the extension study design for both of our SOLD trials. We’ll introduce our next steps in NPDR and DME, including the clinical trial design informed by recent FDA feedback. And will begin to articulate the global commercial opportunity for expaxially, both in wet AMD and beyond.

You can register for our Investor Day by visiting the Events page on the Investor Relations section of our website. We believe this event will clearly demonstrate the breadth and depth of our strategy, and why we believe EXPAXLY is poised to redefine the standard of care in retinal treatment. Let me now turn to our financial position. We ended the second quarter with over $390,000,000 in cash and cash equivalents. In June, we opportunistically raised gross proceeds of approximately $97,000,000 through our existing at the market or ATM facility.

Opening the ATM this quarter was a deliberate decision to provide us with maximum financial flexibility as we head into the most significant data readout in Ocular’s history. We expect this increased capital will support several key initiatives we’ll be speaking more about in our upcoming Investor Day, including investments in commercial infrastructure, preparation for the SOLA-one and SOLA-one extension study, and planning for FDA aligned future studies in NPDR and DME. Importantly, we remain disciplined stewards of capital. We remain well financed with expected runway into 2028, which is well beyond anticipated top line data readouts for both SOUL-one and SOLAAR. Our cash guidance does not yet factor in the full impact of potential clinical trial activities for ex Paxley in NPDR or the long term extension study in wet AMD as we remain at the planning phases for these programs.

2025 is already proving to be a breakout year for Ocular Therapeutix. In just the past few months, we have advanced two complementary registrational trials, aligned with FDA on next steps in diabetic eye disease, and laid the groundwork for commercial readiness in wet AMD. If approved, we believe Expaxly has the potential to be the first product for wet AMD with a superiority label. This would likely be the only product with a superiority label for the foreseeable future with redosing potentially as infrequently as every twelve months. This profile would provide expaxly with a unique and potentially dominant position compared to all other products in the commercial landscape, unlocking an opportunity in wet AMD alone that spans millions of patients worldwide.

To summarize the updates on today’s call. First, both SOLA-one and SOLAR continue to advance with exceptional retention, trial integrity, and physician adherence to protocol, reinforcing our confidence in the quality of data we are generating. Second, in SOUL-one, the vast majority of rescue treatments remain aligned with the protocol defined 15 letter loss threshold. Third, building on this momentum, we plan to incorporate a long term open label extension study for both SOUL trials. This is a strategic effort to potentially generate long term safety and visual outcomes data with a non pulsatile treatment that could meaningfully support physician confidence and market adoption.

Fourth, we have high confidence in the success of SOLAR, and we expect top line data in the 2027. With a six month screening and loading phase designed to exclude unstable patients, and a primary endpoint at week fifty six, timed two months after the most recent ex Paxil aflibercept injections, we believe we have taken steps to de risk the patient population and maximize the opportunity for success. Fifth, we’ve streamlined and simplified the SOLAR rescue criteria to a greater than five letter loss, plus a greater than or equal to 75 micron increase in central subfield thickness. We believe this change enhances SOLAR’s real world relevance and reflects our continued confidence in ex Paxley. Sixth, we’re preparing to expand into NPDR and DME.

Following positive FDA feedback, we believe ex Paxley could redefine treatment in diabetic eye disease, offering durable protection with just one or two injections per year. Seventh, we remain well capitalized with over $390,000,000 in cash and expected runway into 2028, well beyond anticipated top line data for both SOLA-one and SOLAR. Our recent sale of $97,000,000 of common stock under the ATM provides financial flexibility to support both near term execution and long term strategic investments. And finally, we look forward to hosting our Investor Day on September 30 in New York City, where we will provide deeper insights into the SOLE trials and the SOLE trials extension study, our diabetic eye disease strategy, and our global commercial vision. At Ocular, we’re not just developing a drug.

We’re redefining the retina experience with confidence, clarity, and conviction. We hope you all plan to join us at our Investor Day on September 30. Thank you again for your time and continued support. Operator, we’re now ready to take questions.

Conference Operator: Your first question comes from Byron Amin with Piper Sandler. Please go ahead.

Byron Amin, Analyst, Piper Sandler: Yeah. Hi, guys. Thanks for taking my questions, and congrats on all the progress. I have a multipart question for SOLAR. So I guess first question, when do you expect to complete randomization of the five fifty five patients that are required for the trial?

Second question, what drove the change in the rescue criteria for the study? And I think you removed the 10 letter loss requirement for the rescue criteria. So if you could just confirm that. And third, I guess, was there anything like on a mass basis that you saw in solar that basically drove that change in the rescue criteria? And I guess why was that?

Why was this changed on at this time? So those are I guess the three questions that I have on SOLAR. Thanks.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Baron, good morning and thank you for your questions. So let me just answer that in order. First of all, as far as randomization is concerned, look, we will update you when appropriate. What we’ve said very clearly is that our enrollment has been completed. And that the trial conduct is going superbly.

We’re very, very happy with the way that the conduct of SOLAR and SOLAR one for that matter is going on. As far as what drove the change, I just want to be very, very clear on this. This modification of the SOLAR rescue criteria was based purely for strategic advantage. Purely for strategic advantage. It was not required by the FDA.

And it was based on a position of confidence as far as what we’re seeing in the mass data in SOLAR-one is concerned. To put it very simply, if you step back and if you look at three studies, and I say three because I include the SOUL extension study, there’s a purpose. Again this is simplistic but it’s actually quite effective. There’s a purpose for each study. The purpose for SOUL I is a superiority label.

That’s very important to us. The purpose for SOULAR is clinical use and clinical relevance. The purpose for the SOLAR extension study is data generation that supports the superiority label as well as the long term clinical advantage. And what we have done from a position of confidence is to go ahead and modify the rescue criteria for SOLAR to better get it towards its goal which is data generation for clinical use and clinical relevance. And why now?

It’s really quite simple. It’s because of two things. One is, again it’s from a position of confidence. One is because we see the SOUL-one MASS data and we’re very, very excited by it. We’re very confident.

Our confidence continues to grow as we see the MASS data. And the second reason is the feedback that we get from investigators. What we want to do is we want to set this drug up to be adopted immediately upon its approval. And by reflecting rescue criteria that are going on in the community currently, we’ll make it much more adoptable immediately and answer all the questions that need to be answered for full acceptance. And that’s really the reason.

Again, this is a decision that’s made from a position of confidence and it reflects a strategic advantage that we will enjoy. Thanks for your question, Barry.

Conference Operator: Next question, Tazeen Ahmad with Bank of America. Please go ahead.

Tazeen Ahmad, Analyst, Bank of America: Hi, good morning. Thanks for taking my question. Praveen, I just wanted to clarify how you’re thinking about any potential for a shortened review timeline, given that you’re going to file your application after SOLAR reads out. Do you have any preliminary feedback from the agency, or would this be something that you would need to discuss with them, and would you need the full SOLAR study data in hand in order to get any kind of clarity, or could you start a process before that in terms of filing? And then secondly, when should we think about the pace with which you’ll start for preparing for the potential launch of drugs?

Thanks.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: So Tazeen, good morning, and thank you for your question. First of all, look, our expectation of what the FDA wants has not changed. And the FDA has been very clear in stating that they want two well controlled, well masked studies with positive results. They are well aware of what we’re doing. You remember that we do have a SPA for SOLO-one.

We have a written Type C confirmation for SOLAR. And we expect to be able to submit for approval immediately following a positive result for SOLAR, which is at fifty six weeks. Now, what we also said was that we do have a drug here that will qualify for a five zero five(two). Now remember, the typical pathway that most people are used to is the five zero five B1, which is a new molecular entity. This is usually reserved for drugs that have never been approved with drug particles that have never been approved, or drug API that has never been approved.

In our case, because ex Paxley has been previously approved, we believe that the five zero five(two) path will shorten our time period by at least two months. In regards to launch activities, look, you will be seeing some discussion in our Investor Day, and I hope everybody will be able to attend our Investor Day. We will outline for you our outlook in terms of a national as well as a global commercial strategy at that time. Thank you Tazeen for your question.

Conference Operator: Next question, Tara Brenkopf with TD Cowen. Please go ahead. Hi, good morning and thanks for taking the question. So I want to go back to the theme of Biren’s questions. So for the updated rescue criteria, can you just help us to better understand how the number and timing of the rescues will be viewed by the FDA when evaluating the primary endpoint for SOLAR and how that differs from the previous criteria.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Yes, so Tara, good morning and thank you for your question. There’s really no change whatsoever in how the FDA would look at this in terms of the primary endpoint or anything else like that. Again, as I stated earlier on, this modification was based purely on getting a strategic advantage and making this drug immediately adoptable because it reflects what is being done clinically. There’s absolutely no FDA requirement whatsoever. And we expect no change in terms of the way the FDA regards this study.

Thank you.

Conference Operator: Okay, great. Thanks so much. Next question, Colleen Cuske with Baird. Please go ahead.

Colleen Cuske, Analyst, Baird: Great, thanks. Good morning. Thanks for taking the question, and congrats on the progress. I understand the change in rescue criteria is not a regulatory decision, but did you speak with the FDA about this change in criteria or would you plan to do so? And then can you just confirm, I think the rescue criteria that you’re no longer using is just a pure 10 letter loss with no fluid stipulation.

And so how do you think removing that criteria would impact the primary endpoint?

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Yeah, good morning Colleen and thank you again for the question. Just like I said to Tara, previously, this has nothing to do with the FDA whatsoever. It’s a purely strategic decision. It’ll have no issue whatsoever with the primary endpoint. This is really not an FDA discussion.

This is a pure strategic decision that we’ve made to better reflect the purpose of SOLAR, which is to completely define this drug to be adoptable immediately for clinical use. There will be, this is again, I’ll reiterate, has nothing to do with any kind of an FDA requirement. It’s a pure strategic decision. Thank you Colleen.

Colleen Cuske, Analyst, Baird: Got it, that’s helpful. And one follow-up if I can. Just from an operational standpoint, obviously SOLAR is already kind of up and running and the change is happening in the trial. So can you speak to what percent of rescues in SOLAR were for the other criteria? And does this change by chance delay the primary endpoint readout?

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Yes, so Colleen, again, this doesn’t do anything for the endpoint at all. This does not delay or change the timing of SOLAR one bit. Recall that one of the great benefits that we have in SOLAR is the trial design. The trial design is unique in completely de risking the patient population as much as we can. Recall that what we have here is a very well thought out ramp where we have five injections and we have a unique design in having two opportunities to observe patients for instability.

So it’s quite a long ramp and it really doesn’t change anything in terms of the patient outcomes whatsoever. Thanks for your question.

Conference Operator: Next question, Kelly Shai with Jefferies. Please proceed. Congrats on the great progress and thanks for taking my questions. Maybe for the first one, for the single long term extension study for both trials, maybe could you explain to us the rationale and the purpose of such design? How much long term data do you think you need to collect for commercially meaningful impact?

And also, I have a follow-up. Thanks.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: So, Kelly, good morning, thank you for your question. It’s an important question. So let me kind of step back a little bit and answer this in a more holistic way. Especially at this time and appropriately, it’s important to sort of reflect what these trials are doing and why they fit in and how they fit in. And what I’m about to say, I want to be very, very, very clear.

I’m going to talk from a position of confidence. Everything that I’ve said regarding this drug has been from a position of confidence. And my confidence in this drug has not changed one bit. And I stand by absolutely everything that I’ve said. What people ask me often is really what defines success for this drug?

And people look at numbers as many people do. And there’s nothing wrong with that. And obviously we’re very confident about the numbers. We’ve got to hit the primary endpoint. We’re very confident about the way the clinical trial is going as far as both trials are concerned.

But in this case SOLO-one. But really what will define in my opinion, the real success of this drug is being able to get a superiority label. And let me explain that. What you see now in this field is really a morass of me too drugs. And that’s based on non inferiority studies.

As far as I know, SOUL-one is the only superiority study that’s active. And in fact, I don’t even know if another superiority study that’s planned. So what does that do in terms of the advantage that we would have, right, if we’re fortunate enough to get a superiority label? So what I would say is let me answer that question in terms of the doctor and let me answer that question in terms of the company itself. As far as the doctor is concerned, the doctor wants to be in a position to choose the drug, the best drug possible for the patient.

And if there’s a pressure based on competition, based on pricing and so on and so forth and step therapy, the doctor may have to wait until the patient is actually worse on a lesser drug before being able to switch to a better drug or the drug that’s desired. And often times what happens in this case as has been shown in previous diseases in retina is that the patient really never recovers. There’s damage done that’s irreversible. Now why have we extended the SOUL studies and why have we put in the questions that we want to answer? Well one of the questions very clearly is what happens to patients when there’s a delayed adoption to expaxially?

And we want to be able to see if that causes any damage that’s irreversible. If there’s an advantage, we believe there will be to starting expaxially right away. So from a doctor’s point of view, that extension study question is very, very important. From a company’s point of view, having a superiority label puts a great deal of value on the drug as well as the company. It puts the drug in an entirely different orbit.

Again, I don’t know of any other drug that is currently being investigated based on superiority. So getting the superiority label, putting these studies together to answer the proper questions to support that superiority label, particularly the SOUL extension study is going to be very important in terms of the value of the drug and value of this company. Thank you for your question.

Conference Operator: Super helpful. I also have a follow-up, if I may. So besides meeting the regulatory bar for approximately two pivotal trials in YAMD, curious, what is the commercial bar in your mind for to gain dominant position in the wet AMD market in terms of how many letters of a BCVA loss from baseline maybe at thirty six weeks or fifty two weeks? Thanks.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Yes, so Kelly, it’s a great question and it’s an appropriate question. Thank you for the question. First of all, look, the most important thing for us to do is to conduct a study in a way that we will allow this drug to show itself. And we’re very, very firmly committed to doing that. And our confidence in this drug has always been great and continues to grow every day in terms of meeting the primary endpoint.

That’s what we have to do. From that point on what we intend, we’ll have a lot of data. And what we intend to show is data that will show a clear profile of this drug. We’ll have data regarding the delta, we’ll have data regarding the visual acuity, regarding anatomy, so on and so forth. And what we also intend to do is to show the data in a way that maximizes the confidence in the translation of a positive SOLA-one study to SOLAAR.

We realize how important that is and I hear that. It is very important. Although we realize that the patient population is different in a bespoke manner and intentionally so, the drug is the same. And I totally get the fact that when we show the positive SOLO-one data it has to be shown in a way that allows you and everybody else to be very confident the translation of that success to SOUL R. And we will do that.

So based on all of those things and based on us having the potential to get a superiority label, I think we’ll have more than enough data that physicians can look at the culmination of all the results that are there and say, this is a drug that will be translatable to the way I go ahead and treat my patients. And the superiority label allow me to make sure that I can use this the way I want to use it for my patients and that drug will be protected. That’s the important part. Thank you, Kelly.

Conference Operator: John McCutcheon with Raymond James. Please go ahead.

John McCutcheon, Analyst, Raymond James: Hi, thanks for the question. And just picking up on that last point for Veeam. Can you speak to the impact of having twelve month follow-up for SOUL I as a read through to SOUL R? And whether you anticipate having visibility into a meaningful proportion of patients out to say fifteen or eighteen months on SOL-one at that point to get a read on the impact of redosing? Thanks.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Thank you. It’s a great question. I appreciate the question. I think as I say, we will be providing, we’ll have a lot of data right away and we’ll be providing data in a way that we will absolutely head on address that issue. As of now, I can’t tell you that we’ve advised you to what data cuts we’ll be providing.

But look, I hear you. I hear everybody, the company hears everybody in saying, we need to provide you with that link from SOUL1 to SOLAAR. We’re absolutely going to be set up to do that. Thank you for the question.

Conference Operator: Next question, Lisa Walter with RBC Capital Markets. Please proceed.

Tazeen Ahmad, Analyst, Bank of America: Good morning. Thanks so much for taking our questions. Maybe a first one Just wondering if you can clarify a detail for us on off protocol rescues. For the on protocol rescue injection criteria, very clear that patients must lose 15 letters or more, but wondering where patients who have hemorrhage fall into, whether they fall into the off protocol or on protocol rescue criteria.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Yeah, good morning Lisa, and thank you for your question. Look, in every single study and having done clinical trials for thirty years before this job and the job before, what I’ll tell you is that in every single clinical trial there’s a section there that says that the patient may be rescued per the doctor’s discretion. And that has to be there to pass the IRB. That is to protect the patient. And the doctor can rescue the patient based on his or her decision if they feel that that is the safest thing for the patient.

As far as the protocol for SOLO-one is concerned, it clearly states that the primary endpoint is based on the rescues. And the rescues consist of 15 letters or more of loss of vision or any kind of hemorrhage that threatens the macula. Now what I will say and what we’ve been saying over and over again is that the vast, vast majority of patients here are being rescued based on the loss of 15 letters of vision and the protocol is being followed. And that’s very important. Thank you Lisa for your question.

Conference Operator: Next question, Yi Chen with H. C. Wainwright. Please proceed.

Yi Chen, Analyst, H.C. Wainwright: Thank you for taking my question. Could you please remind us what was the rescue criteria for SOAR before the change? And how do you expect the change to impact the number of patients being rescued? And also, could you comment on whether there was a change in real world practice in terms of rescue criteria during the past several years? Thank you.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Yes, so thank you for the question and good morning. So as I say the reason that we made the changes, I keep saying, is that it was made purely for strategic reasons. There was no FDA issue whatsoever. As far as the practice patterns are concerned, what I can tell you is when we spoke with RPIs and when we saw what we saw based on a masked basis with SOLA-one, we felt that we did not want any questions whatsoever as to the relevance of the rescue criteria. We wanted to make it as liberal as possible because we were very confident in the drug.

And remember, we have a patient population here that is de risked and selected after a six month loading phase with two opportunities to observe for instability. So we will be randomizing patients that we feel are about as de risked as we can have them based on the ramp that we have. So having seen what we’ve seen and having heard the PIs, our decision was to say, you know, we have enough confidence in this drug now that we can go ahead and allow the rescue criteria to be as liberal as possible so there’ll be no question in terms of adoption whatsoever. Again, it was made purely for that strategic reason and we believe that that will allow for a significant strategic advantage. Thank you for your question.

Conference Operator: Next question, John Wallinburne with Citizens JMP. Please proceed.

John Wallinburne, Analyst, Citizens JMP: Hey, thanks for taking the questions for Dean. Just kind of piggybacking on the same rescue criteria theme. You mentioned kind of the investor feedback and the read through from the SOL one to SOLAR criteria, but the criteria is different. So wondering what was the specific feedback you received to prompt this change? And then a second one, you mentioned your expectation was in line and so one for the cadence of rescues.

Wondering what is your expectation for the cadence of rescues for EYLEA versus ex Paxley? Thanks.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Yeah John, good morning and thank you for your questions. So again, going back to the rescue criteria, the feedback really we got was very, very simple. It was look, I want this drug, I want this as soon as it’s out there and I wanna make sure that my rescue criteria now in terms of what I do for patients is aligned with what I see from SOLAR. And people have different rescue criteria in real life, but we wanted to make it so that even folks that will be rescuing based on the most liberal of criteria are able to basically have a translation directly from SOLAR. And again, this reflects our level of confidence in this drug that we see in a masked fashion.

As far as your question regarding the cadence of rescue and SOLO-one is concerned, let me go back to what we’re looking at. We’re looking at three things as I’ve said. The first one is the number of rescues. We’re looking at the cadence of rescues which means that we want to make sure that we see a pattern of rescues that we expect. And we absolutely do.

We have great confidence that we’re seeing the kind of rescues that we would expect, again in a masked fashion. And the third thing that we look for is we look to make sure that these rescues are being done on protocol. And on all three of those parameters we are very, very, very happy. And we continue to see a consistency in those patterns, as I’ve said from the very beginning, that gives us a great deal of confidence in the results of SOLO-one. Thank you for your question.

Conference Operator: Greg Harrison with Scotiabank. Please go ahead.

John McCutcheon, Analyst, Raymond James: Hi, everybody. This is Joe Thomas on for Greg Harrison. Thank you for taking our question. Just one based on the updates today, just how should we investors be thinking about the interplay of the eventual time to market for ex Paxley with the potential superior label to competitors who might possibly enter the market slightly sooner? Thank you.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Yes, good morning and thank you. Look, I keep on emphasizing that that’s one thing that I think is really quite underappreciated, which is the position that we will potentially have with a superiority label. Again, I’ll reiterate if you’re just going to step back and look at this market. Every drug is based on a non inferiority study. The difference between these drugs are very slight if any at all.

And when you have a situation like that, when you have a morass of drugs that pretty much look the same, the competition is basically based often on pricing with very little to distinguish the drugs. And as someone who’s practiced for thirty years, I realized that the downstream pressures of something like that. And the downstream pressures of something like that is that the relationship that a doctor has with a patient is taken away or at least impacted. Because the choices that are made for the drug are being forced to be made based on pricing. And often times the consequences of that are really very bad for the patients.

Again, we have studies in chronic diseases in retina where if the patient is started on the proper drug in a delayed fashion, the vision never recovers. The vision may improve but really never recovers to the extent that it should have been. And again, as I said earlier on, this is a major point of study for extension, our sole extension study. We will have unique data there where we’re able to see what happens to patients who are started on Oxpaxil after a two year delay. We’ll have an opportunity to see if that catches up or not.

And when we see something like that happening where there’s irreversible visual loss from a delay in treatment, that has a tremendous impact on patients chronically. So with a superiority label, our expectation is that we’ll be in a different orbit. We will be immunized from the rest of the drugs and the rest of the pressures that they may feel. This will add a great deal of value to the drug, to the company, and most importantly, we believe that this will allow for better patient care and better long term outcomes. Thanks for the question.

Conference Operator: Next question, Lachlan Hanbury Brown with William Blair. Please proceed.

John McCutcheon, Analyst, Raymond James: Hey, guys. Thanks for the question. I was curious on the reason for starting the open label extensions now versus having them up and running previously. Praveen, you mentioned that, obviously, you’ve been in the space for a while, seeing the data from all these studies showing long term benefits. So knowing the value that that can provide, like why did you not originally start them and why did that change now?

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Again, thank you. Good morning and thanks for your question. There’s really no reason other than a logistic. At a certain point, you start these studies with what you see under masking, with again with a great deal of confidence and you step back and you say what questions can we answer with this drug? And what questions would be most clinically relevant to be answered?

And that’s the questions that we’re asking. Again, we’ll have a lot more detail regarding what the extension study will look like. And further questions that we’ll be asking in the extension study in our Investor Day on September 30. Thank you for the question.

Conference Operator: Bill Maun with Clear Street. Please go ahead.

Bill Slattery, Jr., Vice President of Investor Relations, Ocular Therapeutix: Good morning. Thanks. So you mentioned excluding patients with high fluctuations in OCT from the trial to reduce noise, which makes sense. But just looking down the road, do you expect any impact on the commercial effort, either by restrictive label discussing excluding these patients or just understanding among prescribing community that these patients were excluded from the trial? Thank you.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Yeah, good morning and thank you for the question. No, quite the opposite, quite honestly. So let’s just speak from the doctor’s point of view as well as from a label point of view. From a physician’s point of view, what we’re providing is a pure patient population. By reducing the noise, we’re actually providing much more valid scientific data.

So from a physician’s point of view or a clinician’s point of view, the data that we’re providing by providing a pure scientific patient population provides for a pure comparison. So quite the opposite as far as a clinician is concerned. From a labeling point of view, that’s never ever been the case. And the most recent example that I have from a personal viewpoint is my last company. In Iveric Bio, the same question was asked about label restrictions.

You recall, all the studies were done with patients with extrafoveal geographic atrophy. In fact, not a single patient with fovea involving geographic atrophy was ever studied. And this question was always brought up. And as you can see in the label, there are no restrictions at all. And there are numerous examples of that going all the way back to ANCHOR and MARINA and visual acuity restrictions in terms of patient enrollment to PANORAMA for instance, looking at diabetic retinopathy in only a certain group of patients.

So history has shown that as long as you conduct a proper scientific study that’s well masked, well conducted, there really will be no label restrictions. Thank you for your question.

Conference Operator: Serge Belanger with Needham and Company. Please go ahead.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Hi, good morning.

John Thomas, Analyst, Scotiabank: This is John on for Serge today. Congrats on all the progress, Praveen. Just to touch on again the translation of SOLO-one data to SOLAR and considering the distinct purposes and criteria you noted for each trial, do you view the readout of SOLAR1 as a derisking event for SOLAR or more so complementary considering they’re answering different questions?

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Good morning and thank you for your questions. A great question. So what I will tell you is, look, it’s clearly both. Again, I’ll repeat this. I know there’s a great deal of interest in looking at the SOLO-one results and seeing the translation into SOLAR.

That in my mind is completely appropriate and understandable. The patient populations are deliberately different. The drug is the same. And we will address that. I hear you.

I appreciate it. We will address that in the data cuts that we will release to give you confidence in the translation of a positive SOLO-one study to SOLAR. Now having said that, I will also say that there are several, two important things that are right in front of you that should give you a great deal of confidence. One is the patient selection and the other is the clinical trial design. As far as patient selection is concerned, look every single anti VEGF study that I know looks the same.

After two or three injections visual acuity stabilizes. Every single one of them. And the curve looks exactly the same no matter what the anti VEGF agent is. We’re going well beyond that. We’re injecting five times prior to randomization.

Not only are we doing that, but we have two unique windows, two opportunities to look for instability. So the patients that we are randomizing are about as de risked as we can make them. So that in itself should give a great deal of confidence in terms of patient selection. The second thing in regards to clinical trial design, remember that our primary endpoint is at week fifty six. It’s a singular endpoint.

It’s not a blended endpoint. It’s a singular endpoint. This, in our opinion, is an optimal endpoint because two months after the last Ex Paxil injection and the last Eflibercept injection. So given those two things, you already should have quite a bit of confidence in the success of SOLAR. But having said that, I completely understand and hear that the SOLAR-one positive results will have to allow you to translate that success into SOLAR.

We hear you, we understand you, and we intend to address that. Thank

Conference Operator: concludes our question and answer session. I will now turn the call back over to Doctor. Praveen Dugel for closing remarks.

Dr. Praveen Dugel, Executive Chairman, President and CEO, Ocular Therapeutix: Thank you very much. Once again, I’d like to thank everyone for taking the time to join our call today. We look forward to updating you on our progress. If you have any follow-up questions, please contact Bill Slattery, our Vice President of Investor Relations. Please also register for our Investor Day.

Have a great day everybody. Thank you.

Conference Operator: This concludes today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

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