Ocular Therapeutix Q1 2026 Earnings Report

Ocular Therapeutix EPS Results

• Actual EPS: N/A
• Consensus EPS: -$0.32
• Beat/Miss: N/A
• One Year Ago EPS: -$0.38

Ocular Therapeutix Revenue Results

• Actual Revenue: N/A
• Expected Revenue: $12.72 million
• Beat/Miss: N/A
• YoY Revenue Growth: N/A

Ocular Therapeutix Announcement Details

• Quarter: Q1 2026
• Date: 5/5/2026
• Time: Before Market Opens
• Conference Call Date: Tuesday, May 5, 2026
• Conference Call Time: 8:00AM ET

Ocular Therapeutix (NASDAQ:OCUL) is a biopharmaceutical company dedicated to the development of innovative therapies for diseases and conditions of the eye. Founded in 2011 and headquartered in Bedford, Massachusetts, the company focuses on sustained-release drug delivery platforms designed to address key unmet needs in ophthalmology. Its proprietary hydrogel-based inserts and sealants aim to improve patient compliance and outcomes by providing controlled release of active pharmaceutical ingredients directly to ocular tissues.

The company’s flagship product, DEXTENZA®, is a preservative-free, sustained-release dexamethasone intracanalicular insert approved by the U.S. Food and Drug Administration for the treatment of ocular inflammation following ophthalmic surgery. Ocular Therapeutix also markets ReSure® Sealant, a synthetic polyethylene glycol-based hydrogel approved to seal corneal incisions and reduce postoperative fluid egress. These products exemplify the company’s strategy of combining novel delivery systems with established drug compounds to enhance safety and efficacy.

In addition to its marketed therapies, Ocular Therapeutix maintains a pipeline of investigational candidates targeting conditions such as glaucoma and dry eye disease. Key programs include OTX-TKI, a tyrosine kinase inhibitor insert under development for glaucoma, and OTX-DED, an insert incorporating low-dose dexamethasone for chronic dry eye. The company leverages partnerships and licensing agreements to expand its technology platform and advance clinical programs.

Led by Chief Executive Officer Antony Mattessich, Ocular Therapeutix operates manufacturing and research facilities in the United States and collaborates with contractors and distributors to support commercialization. The company’s management team combines expertise in ophthalmology, drug delivery, and regulatory affairs to guide product approvals and market access strategies within the U.S. and select international markets.

Ocular Therapeutix Q1 2026 Earnings Call Transcript

Key Takeaways

• Positive Sentiment: AXPAXLI demonstrated statistical superiority to aflibercept in SOL-1 (primary endpoint P=0.0006) with unmatched durability—about two-thirds of patients maintained vision after a single injection for a year.
• Positive Sentiment: The company reported a reassuring safety profile for AXPAXLI in SOL-1, with no treatment-related serious ocular or systemic adverse events (e.g., endophthalmitis or vasculitis) observed in presented subject-level data.
• Positive Sentiment: SOL-R exceeded enrollment expectations (631 randomized vs. 555 target) with top-line now guided to Q1 2027, and SOL-X (a 3-year open-label extension) has begun enrollment to evaluate long-term outcomes and crossover effects.
• Neutral Sentiment: Ocular plans to submit an NDA relying on SOL-1 week‑52 data and to use the 505(b)(2) pathway, but formal discussions with the FDA are ongoing and could affect timing or data requirements.
• Neutral Sentiment: The company ended Q1 with approximately $667 million in cash, providing runway into 2028 to support trials, NDA activities, and commercial readiness, although this figure does not include the full anticipated commercialization expenses.

Presentation

[Operator]

Morning, and welcome to the Ocular Therapeutix first quarter 2026 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. If you would like to ask a question, please press star one on your telephone. As a reminder, this conference call 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, Bill Slattery Jr. Please go ahead, Mr. Slattery.

[Bill Slattery Jr., VP of Investor Relations at 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 first quarter of 2026. During today's call, Ocular's Executive Chairman, President, and CEO, Dr. Pravin Dugel, will summarize recent business highlights before we move to our question-and-answer session. Joining Dr. Dugel for the Q&A portion of the call will be Donald Notman, Chief Operating Officer, Sanjay Nayak, Chief Strategy Officer, and Steve Meyers, Chief Commercial Officer. We refer everyone to this morning's press release and our Form 10-Q for a comprehensive update of our first quarter 2026 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.

[Bill Slattery Jr., VP of Investor Relations at Ocular Therapeutix]

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-K and our other SEC filings. With that, I'd like to hand the call over to Dr. Pravin Dugel to review our recent updates. Pravin.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Thank you, Bill, and thank you all for joining us this morning. 2026 is off to a tremendous start for Ocular Therapeutix, and I want to begin by stating this clearly. SOL-1 has fundamentally changed the conversation in wet AMD. In February, AXPAXLI became the first novel investigational therapy to demonstrate superiority to an approved anti-VEGF agent in a phase III wet AMD trial. That has never been done before. The magnitude, consistency, and statistical strength of the data with a p-value of 0.0006 for our primary endpoint are giving the retina community great confidence in the robustness of the result and the probability of a potential approval as we prepare to submit our NDA based on SOL-1 week 52 data, subject to ongoing formal discussions with the U.S. FDA.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Beyond the statistics, what truly excites us is the clinical significance of the data. AXPAXLI delivered unmatched durability and sustained disease control with substantially fewer rescues. In two-thirds of the patients, just a single AXPAXLI injection maintained vision for an entire year. That is not incremental progress. That is true differentiation. Most importantly, we're not slowing down. Just last week, we announced the initiation of enrollment in SOL-X, our long-term extension trial in wet AMD designed to explore AXPAXLI's impact on the long-term outcomes that matter most to patients and retina specialists. Since the top-line announcement, we have continued to analyze the SOL-1 results, and each successive data presentation only strengthens our conviction. Both at The Macula Society and most recently at the Vit-Buckle Society annual meeting, we presented additional 52-week analyses that further reinforce AXPAXLI's unprecedented profile.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

For example, when we look at time to fluid volume increases, specifically thresholds of greater than 30 µm and 75 µm from week , subjects treated with AXPAXLI took about 5-6 months longer to reach those thresholds as compared to subjects in the aflibercept arm. This is exceptional disease control. Why does this matter? Fluid is the key marker of disease activity in wet AMD. Lower fluid accumulation reflects slower anatomic progression, and slower anatomic progression reflects sustained disease control. That has important implications for the long term, which we are further evaluating in SOL-X. Over time, inconsistent or pulsatile VEGF suppression, as we see in today's real-world clinical practice, may contribute to irreversible changes such as fibrosis and atrophy. What AXPAXLI may offer is something fundamentally different, continuous zero-order drug release and consistent disease control, which we believe could significantly alter the long-term trajectory of disease.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

What we have seen to date in SOL-1 with AXPAXLI is not just durability in terms of dosing intervals. It is also durability in terms of disease control. That distinction will continue to be important. Furthermore, when you consider the patients who were randomized in SOL-1, it becomes even clearer that what we have demonstrated with AXPAXLI is simply remarkable. It's worth remembering that SOL-1 enrolled what may be the best seeing wet AMD population ever studied in a phase III trial. As you will recall, treatment-naive subjects needed to reach 20/20 vision or gain 10 letters over eight weeks screening and loading phase to be randomized into the trial. Since we started recruitment, we've consistently said that this population was intentionally selected specifically because they are expected to lose vision.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Yet, with a single injection of AXPAXLI, nearly 75% of patients maintained vision at nine months and 66% maintained vision all the way through 12 months. That is simply profound. We also saw a meaningfully delayed time to first rescue compared to aflibercept. Incredibly, the rescue rate observed in the aflibercept arm at week 28 was not reached in the AXPAXLI arm until six months later at week 52. Just think about that. We're talking about a six-month delay in clinically meaningful disease change. In wet AMD, that kind of separation has never been seen before. It speaks directly to the durability and sustained disease control that define AXPAXLI's profile. Most importantly, AXPAXLI was shown to be well-tolerated in SOL-1. We have made a conscious decision to be extremely transparent with regards to safety simply because it is so important in retinal vascular diseases.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

In our Macula Society and VBS presentations, we went so far as to provide subject-level details showing that AXPAXLI is performing as exactly as expected and is eluding drug and bioresorbing when it should. We did not observe a single treatment-related serious ocular or systemic adverse event such as endophthalmitis or vasculitis that would be caused for concern. Instead, when you combine our superiority, durability, sustained disease control, and a reassuring safety profile, you begin to see the profile of a product that retina specialists could adopt with confidence. If approved, we believe AXPAXLI has the potential to become a foundational therapy in wet AMD. Based on the strength of the results, we remain on track to submit our NDA relying on SOL-1 week 52 data, subject to ongoing formal discussions with the FDA.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

The FDA continues to publicly communicate plans to move to a single registrational trial as the new default option for approvals. The agency's commissioner recently noted that he expects this new framework to be phased in over the next few months or so, aligning with our goal of bringing AXPAXLI to patients as soon as possible. We intend to leverage the 505(b)(2) pathway, which may further allow for a shortened review timeline. Importantly, we are accelerating commercial readiness in parallel. We are building the infrastructure, engaging payers, refining our commercial strategy, and preparing for what we believe will be one of the most important launches in retina in many years. Turning to SOL-R, we completed randomization of 631 subjects in December 2025, exceeding our original 555 subject target. Because of this swift enrollment, we recently accelerated our guidance for SOL-R top-line data to the first quarter of 2027.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

This trial was specifically designed to complement SOL-1. Whereas SOL-1 demonstrated superiority, SOL-R evaluates non-inferiority in a de-risked population. Importantly, our 24-week screening and loading phase occurs prior to randomization, and this is designed to screen out those subjects with high fluid fluctuations, which have notoriously derailed prior non-inferiority trials. The design reflects real-world clinical practice and incorporates rescue criteria more closely aligned with how physicians treat patients. It is powered to provide additional data supporting rapid clinical adoption. Retention in SOL-R is strong, and site engagement remains tremendous. Based on the success of SOL-1, our confidence in SOL-R has never been higher. In addition to SOL-1 and SOL-R, we are thrilled to have recently announced the initiation of enrollment in SOL-X, our open label long-term extension study in wet AMD. Following the remarkable results from SOL-1, where AXPAXLI demonstrated unmatched durability and sustained disease control.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

SOL-X is designed to evaluate the long-term outcomes that matter most to patients and physicians. Subjects who have completed two-year follow-up in SOL-1 or SOL-R will now have an opportunity to receive AXPAXLI for an additional three years in SOL-X, bringing the total follow-up to five years. That is critical because wet AMD is a chronic disease. In clinical practice, we see the consequences of inconsistent disease control over time, progressive damage that can ultimately limit long-term visual outcomes, including through fibrosis and atrophy. Because all subjects in SOL-X will ultimately transition to AXPAXLI, we will have a unique opportunity to observe the consequences of delaying AXPAXLI treatment. Patients initially treated with aflibercept in SOL-1 and SOL-R are exposed to what we would describe as pulsatile VEGF suppression, where disease control can fluctuate over time compared to the continuous suppression we have observed with AXPAXLI.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

If that difference translates into worse long-term outcomes for patients who begin on aflibercept and switch later, it would provide physicians with a clear rationale to initiate AXPAXLI earlier in the disease course rather than waiting. If successful, this has implications far beyond durability. It has the potential to improve long-term vision outcomes, reduce cumulative treatment burden, and importantly, keep significantly more patients on therapy over time, which we believe could meaningfully expand the overall market. When we think about AXPAXLI, we're not just thinking about a more durable therapy. We're thinking about a therapy that has the potential to be transformative over the long term. SOL-X is a critical step in potentially demonstrating that. Beyond wet AMD, our HELIOS-3 trial in diabetic retinopathy remains ongoing. This is a superiority study designed to support a broad label across diabetic retinal disease.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

It allows enrollment of patients with non-central involved DME, reflecting the continuum of disease in clinical practice. On June 17th, in New York City, we will host an Investor Day and plan to provide several important updates across our portfolio. We will provide regulatory updates regarding our NDA submission plan in wet AMD, detailed updates on SOL-R and SOL-X, program updates on diabetic retinopathy, and a first look at our planned commercialization strategy for AXPAXLI. In addition to Ocular leadership, we will feature leading retinal KOLs who will share their perspective on the SOL-1 data, expectations for SOL-R, the evolving wet AMD treatment landscape, and how AXPAXLI could be adopted immediately if approved. We hope you all plan to join us either in person or virtually for what we expect will be an important day outlining the future of Ocular Therapeutix.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

As of March 31st, our financial position continues to remain strong. We ended the first quarter with approximately $667 million in cash, which we expect to provide us runway into 2028. That provides us the flexibility to advance the NDA submission, complete the second year of SOL-1, continue SOL-R, SOL-X, and our HELIOS program, and accelerate commercial readiness. However, our cash runway does not include the full expenses we anticipate we will need to support the commercialization of AXPAXLI. We remain disciplined stewards of capital while investing strategically in what we believe is a transformational opportunity. Before we turn to Q&A, I'd like to close with a few important messages summarizing our incredible position coming out of the first quarter. AXPAXLI has now demonstrated through SOL-1 the first successful superiority outcome for a novel investigative agent in wet AMD against an approved anti-VEGF.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Unmatched durability with sustained disease control through one year. A safety profile that supports broad clinical adoption. In addition, with the initiation of SOL-X, we now have a clear path to evaluating long-term outcomes with AXPAXLI and its potential to fundamentally alter the trajectory of disease. Together, we believe this combination has the potential to redefine the retina experience. Our organization is energized. The data are compelling. Execution remains exceptional. We're advancing with urgency toward our planned NDA submission and potential commercialization. Thank you all for your continued support. Operator, we can now take our first question.

[Operator]

Thank you. As a reminder at this time, if you would like to ask a question, it is the star and one on your touch-tone telephone. If at any point you find your question has been answered, you may remove yourself from the queue by pressing star two. We'll take our first question from Tazeen Ahmad with Bank of America. Please go ahead. Your line is open.

[Tazeen Ahmad, Analyst at Bank of America]

Hi, guys. Good morning. Thanks for taking my question, and thanks for all of the clarification on timelines. Pravin, I just wanted to get a sense of how the discussions with FDA are going. A couple of things. You've been confident on your view that you can apply with just SOL-1 to get approval. Today you provided the good news that SOL-R has enrolled at a pace that you're gonna be able to have data in the first quarter. Maybe can you walk us through the scenarios of what the timeline differences would be if it's decided that you can apply with SOL-1 versus a decision that it might be better to wait for SOL-R? Thank you.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Tazeen, good morning, and thank you so much for the question. Very appropriate question. Look, what we've said today and what we've said in the past, is that we have ongoing formal discussions with the FDA. We couldn't be happier, and I want to stress, we couldn't be happier with the collaboration that we have with the FDA. We feel we're more aligned with the FDA's goals than ever. We check all the boxes. What's been demonstrated to us over and over again in our discussions and in the writings of the FDA is that there are two things that are really important with this single trial submission that I think everybody ought to note. First of all, it's a default position for the FDA. Second, the FDA views this as an elevation of the standards for a clinical trial.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

This is not a lowering of the bar. This is a raising of the bar, and as such, SOL-1 checks all the boxes. It has a SPA. It checks all the boxes in terms of the superiority standard that was reached in terms of safety. We're more aligned than ever. In terms of your question regarding SOL-R, look, we haven't disclosed the timelines as yet. We will when appropriate. I remind you that we have a lot of flexibility here in terms of SOL-R. Nothing is changing with SOL-R. We're continuing with SOL-R with the same kind of efficiency that we've always demonstrated. We're very, very happy with the engagement of the PIs and the enrollment of SOL-R, and nothing has changed. I want to reiterate, we have ongoing formal discussions with the FDA. We couldn't be happier.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

When the time is appropriate, we certainly will update you. Thank you, Tazeen, for that question.

[Operator]

Thank you. We'll take our next question from Biren Amin from Piper Sandler. Please go ahead.

[Biren Amin, Analyst at Piper Sandler]

Yeah. Hi, guys. Thanks for taking my questions. I just wanna welcome back, Donald. Great to have you back, Donald. You know, regarding the ongoing formal discussions with FDA, Pravin, can you maybe just talk about if you've had the pre-NDA meeting with the FDA? That's the first question. The second question, you know, for SOL-1 in the past, you had provided a snapshot on patient discontinuations and patient retention in the study. I was wondering if you could discuss these dynamics for the SOL-R study. Thank you.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Biren, good morning, and thank you, and thank you for the personal note regarding Donald. We too are absolutely thrilled to have Donald back, and he's a essential part of our team. We couldn't be happier that he's back with us. In regards to the FDA meetings, again, I wanna emphasize what I said earlier on, Biren, which is that we are not in the habit of disclosing the details of our FDA meetings, as is true for most sponsors. Suffice it to say that we have ongoing formal meetings that we're very pleased with. The collaboration with the FDA today and has been demonstrated historically could not be better. You recall all the modifications that we've had, and have preserved our SPA with this study.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

We also recall the modifications that we've had with the SOL-R study. All of those have been done in collaboration with the FDA, and we couldn't be happier with their support and their collaboration. As I said earlier, when appropriate, we certainly will update you regarding the timelines. In regards to SOL-R, again, a very appropriate question. As you recall, we had a phenomenal retention rate and execution with SOL-1. That has not changed in SOL-R. We're very pleased with the execution. We're very pleased with the stats that we have in regards to patient retention, and you'll hear the details of that in our upcoming Investor Day. I'm sorry.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

I hope that all of you will be present for that in New York City on June 17th. Thank you for that question, Biren. Back to the operator.

[Operator]

Thank you. We'll take our next question from Tara Bancroft with TD Cowen. Please go ahead.

[Tara Bancroft, Analyst at TD Cowen]

Hi, good morning. I'm going to stick on this theme, if I may. You know, I understand you can't give exact timing and all of that, of course, to preserve the integrity of the discussions. I was hoping maybe you could go over with us what has to be done ahead of a filing, just to get a better sense of the process as you understand it. Kind of separately and related, potentially timing to when we could get an update on data from SOL-X and whether this is going to be part of that review that's expected for the NDA. Thanks so much.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Tara, good morning, and thank you for the question. Look, in regards to the FDA again, you know, I'll repeat that we check all the boxes. We're completely aligned, and I think everything that you've seen from the FDA is in line with their intention of getting drugs to patients faster and making sure that the trials or the single trial approval process is validated. You've seen all the editorials or the editorial in New England Journal of Medicine. You've seen the criteria that was laid out by the commissioner. We check all the boxes, and in our discussions with the FDA, we're more confident than ever that we check all the boxes.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

In addition to that, as I said earlier, SOL-R also provides us a tremendous amount of flexibility. It's important to note again that nothing has changed with SOL-R. We're moving with SOL-R as efficiently, as quickly, with a great deal of integrity, and nothing is gonna change with that. We're moving with that and preserving the flexibility of whatever the FDA should desire. In regards to your question regarding SOL-X and the updates, we will provide more updates in our meeting in June in New York City. Important to remember that SOL-X will provide some very important information in regards to the long-term effectiveness of AXPAXLI. As has been mentioned, SOL-X will provide a lot of data.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Probably one of the most important data points that SOL-X will provide are the crossover patients. We've said earlier that there's a great deal of evidence in our field that what causes long-term decrease in vision is atrophy and fibrosis that is, that is caused by the pulsatile nature of our treatment. I've also mentioned several times that that's akin to having multiple concussions because after all, this is neural tissue. We believe that with continuous suppression that AXPAXLI will provide, and by eliminating these pulsations, we will have a much better long-term outcome by having less fibrosis and less atrophy. Remember, in SOL-X, patients will cross over to AXPAXLI after receiving two years of pulsatile treatment.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

We don't think those patients will ever catch up, and we believe that we'll be able to demonstrate not only the remarkable sustainability and absolutely incredible disease control that we've seen with SOL-1, but we believe we'll also be able to provide substantial evidence that it will provide a better long-term outcome by having continuous suppression. Again, more details on that, Tara, in our meeting in June in New York City, which I hope you will attend. Thank you again for the question, and back to you, operator.

[Operator]

Certainly. We'll go next to Sean McCutcheon with Raymond James. Please go ahead. Sean, your line is open.

[Yang Long, Analyst at Raymond James]

Hi, good morning, team. This is Yang Long for Sean. Maybe can you speak to the optionality of adding SOL-R to the safety database for the NDA submission? Also the risk of unmasking SOL-R if left on the table as it relates to maintaining the integrity of SOL-R for global approvals? Thank you.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Good morning, thank you again for the question. A very appropriate question. I don't want to speak again, as I said earlier on, to the details of our conversations with the FDA. Suffice it to say that they're very collaborative, supportive, ongoing, and formal. What I will say is we have no intention of doing anything different to SOL-R whatsoever. The flexibility that that provides us in terms of the safety database is enormous, let alone the fact that we also have the HELIOS study. It's important to remember that in SOL-1, everybody at week 52 has been redosed. In SOL-1 alone, there's a great deal of redosing experience. Obviously, there's a great deal of redosing experience in SOL-R as well. Again, that affords us a great deal of flexibility.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

On top of that, it's important to note that what we're filing is a 505(b)(2) because both of these entities are previously FDA approved. This drug has a lot of familiarity with the FDA. On top of that, we have a SPA, which we believe will also add to a very efficient filing. Thank you for your question. Again, back to the operator.

[Operator]

Thank you. We'll go next to Lisa Walter with RBC Capital Markets. Please go ahead.

[Lisa Walter, Analyst at RBC Capital Markets]

Good morning. Thanks for taking our question, congrats on the progress this quarter. A couple for me. On SOL-R, just wondering if you can walk us through the secondary endpoints that you expect to share, maybe could you tell us how you are measuring reduction in injection burden as well? Any color here would be helpful. Thanks.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Lisa, good morning and thank you again. In SOL-R, we certainly will plan to share the details with you of what we will study in our meeting in June, wait for the details for that. In terms of injection burden, obviously we're gonna be measuring the rescue rates, again, we'll share the details with that in our meeting in June. It's important to state that I think a lot of the questions that you've asked that you're concerned about, which is very appropriate, have already really been answered in SOL-1. In SOL-1, we certainly see the disease control of AXPAXLI. It's important to remember the patient population difference in SOL-R and SOL-1.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

In SOL-1, patients were specifically and intentionally selected to lose vision, and that's important to understand, and I think that's something that has often been neglected. Despite that patient population, we saw an almost 75% rescue-free rate at week 36, and that's quite remarkable. Perhaps more remarkable, and perhaps even more clinically relevant, is that with a single injection, despite that patient population, 56% maintained a stable CST within 30 microns. Again, I emphasize 30 µm at that time point, and that's unheard of. Remember, using the SOL-R criteria, almost 80% of patients were rescue-free in SOL-1 at six months. We feel that those 20% would perhaps be excluded in SOL-R, given our very long ramp and given the fact that we have two opportunities to observe patients for fluctuations.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

We expect an even higher rescue-free rate in SOL-R. We believe that AXPAXLI is very well-positioned to succeed in the non-inferiority SOL-R trial. Lisa, thank you again for your question. Again, a lot of those details will be addressed in the meeting in June in New York City, which I hope you will attend. Thank you again. Back to you, the operator.

[Operator]

Thank you. We'll go next to Jon Wolleben with Citizens. Please go ahead.

[Jon Wolleben, Analyst at Citizens]

Hey, thanks for taking the question. Just wondering, Pravin, if you could talk a little bit about the feedback you've received and how retina specialists plan on potentially integrating AXPAXLI in the practice based on SOL-1, and how that might change with the SOL-R readouts.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Good morning, and thank you for the question. Great question. You know, that's the discussion going on right now. My colleagues expect to have this medicine in their hands, and the discussion that's going on right now is how will they be using it, and how will they be introducing it to their patients? Which is a great discussion to have. I think ultimately, what I think at least, and this is just my hypothesis, is that this is the ideal drug to be every six months, fixed dosing drug.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

As I've said, to have a drug that lasts, that is a fixed dosing confident, every six-month drug, one also has to be confident that that drug will last beyond six months, maybe 9-10 months, in case the patient gets sick, the doctor is on vacation, that kind of thing. This is the ideal drug for that. How doctors will get to that fixed dosing is something that I think will be explored by the community. Some feel that they'll directly go to fixed dosing. I've had those discussions with my colleagues. Others feel that what they will initially do is to have an extended treat and extend that will continue to give them more and more confidence to go to that every six-month fixed dosing.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

However they go there, I believe that's where this drug will end up. I think that will transform the way we treat patients with wet AMD. In fact, I think that will align us with the rest of medicine. I've always said that, treat and extend, which is what we do now, is sort of opaque. If you ask your 10 KOLs what treat and extend means, you'll get 10 different answers. There's really no study on treat and extend in a phase III program. Treat and extend is not on any label, it certainly is not aligned with anything we do in medicine.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

You don't go to your cancer doctor and say, "Look, I'll wait until your bladder cancer comes back before I decide how often to see you." You certainly don't go to your cardiologist, who says, "Look, I'll wait for your first heart attack before I figure out how often to treat you." This type of fixed dosing I think is aligned with medicine. I think there's good scientific data to support it, and I think that this drug is ideal for every six-month dosing. The other important thing is that the adaptability, I think, will be very, very quick, and it will be seamless. Nothing changes for the doctor. The workflow doesn't change. The experience doesn't change. It's a self-sealing 25-gauge needle. There's not a single new piece of equipment to buy. There's no added overhead.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

I think the adaptability of this will be absolutely seamless. I know that in talking to my colleagues, they are very enthusiastic to use this drug as soon as it's marketed. Thank you for your question, and back to the operator.

[Operator]

Thank you. We'll go next to Yi Chen with H.C. Wainwright. Please go ahead.

[Yi Chen, Analyst at H.C. Wainwright]

Thank you for taking my questions. Pravin, could you comment on whether there are any patients who have dropped out of the SOL-1 trial and whether any patients from SOL-1 who are eligible to enroll into the SOL-X trial have chosen to do so? If not, what are their reasons for not enrolling into the SOL-X trial? Thank you.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Thank you again for your question. We haven't given the actual numbers, but suffice it to say that the retention rate is absolutely remarkable, and I'll go so far as to say that the retention rate is probably better than any other retina phase III study that we know of. This speaks to the enthusiasm not only of the patients but also the doctors. Historically, this is borne out, right? I go back to LUCENTIS and EYLEA, for instance. LUCENTIS had a seven-year head start. EYLEA came in seven years later and extended the durability by maybe a week or two and absolutely dominated the market. You see the same kind of thing with VABYSMO now. This is a real need in our community. Doctors know this. Patients know this.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Seeing the data that they've seen with SOL-1 makes it very, very easy for patients and for doctors to stick with this program. There's been an overwhelming amount of enthusiasm. We haven't given you the actual numbers, but again, the retention rate of this program, I'll go so far as to say is higher than any other phase III program that I know, and the enthusiasm is through the roof at this point. Thank you for your question. Back to the operator.

[Yi Chen, Analyst at H.C. Wainwright]

Thank you.

[Operator]

Thank you. As a reminder, if you would like to ask a question, that is the star and one on your telephone keypad. We'll go next to Lachlan Hanbury-Brown from William Blair. Please go ahead. Your line is open.

[Truman Dunkley, Analyst at William Blair]

Hi. Truman Dunkley on for Lachlan. I just wanted to ask, for the HELIOS-3 study, can you remind us if there's a certain proportion of patients that you will need to enroll with non-CI DME to ensure that you have enough data to get DME in the label?

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

No, thank you for your question. Good morning. There is really no such requirement that we have guided you to. You know, what I will say is we are very confident that we will not need to do another diabetic retinopathy study to cover all of diabetic retinal disease. I say that because remember, what we're doing is enrolling patients with a moderate to severe non-proliferative diabetic retinopathy with non-central involving diabetic macular edema with an ordinal endpoint, which captures every facet of change with non-proliferative diabetic retinopathy. The FDA historically has given approval based on the disease as opposed to the clinical trial. We absolutely believe that we will have a label that will cover all of diabetic macular edema.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

You've seen evidence for this over and over again. If you go way back to ANCHOR and MARINA, for instance, there was a restriction in visual acuity in enrollment, and you see that for LUCENTIS, there is no restriction whatsoever. You look at PANORAMA, there is no restriction for a stage of non-proliferative diabetic retinopathy in the label. Most recently, my last company, Iveric Bio, recall that we didn't treat a single patient with center involving geographic atrophy, yet if you look at the label for IZERVAY, it allows for all of geographic atrophy, fovea involving and non-fovea involving. In the same way, we believe that with the label eventually, for AXPAXLI will cover all of diabetic macular edema, central involving and non-central involving.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Also recall that everybody with diabetic macular edema, everybody also has non-proliferative diabetic retinopathy. All of diabetes will be covered, we believe, by the label. I will add that obviously we haven't had labeling discussions with the FDA. It is far too early for that. We firmly believe that this will be the only trial that will be necessary in the HELIOS programs for a broad label encompassing all of diabetic retinopathy. Thank you again for the question. Back to you, operator.

[Operator]

Thank you. At this time, there are no further questions in queue. This concludes our question and answer session. I will now turn the call back to Dr. Pravin Dugel for closing remarks.

[Pravin Dugel, Executive Chairman, President, and CEO at Ocular Therapeutix]

Thank you. Once again, thank you all for joining us today, and thank you for your continued support. We hope you will join us on June 17th in New York City for our upcoming Investor Day. In the meantime, if you have any questions, please reach out to Bill Slattery, our Vice President of Investor Relations. Have a great day, everyone, and thank you.

[Operator]

Thank you. This brings us to the end of today's meeting. We appreciate your time and participation. You may now disconnect.

Participants

Executives

• Bill Slattery Jr., VP of Investor Relations
• Pravin Dugel, Executive Chairman, President, and CEO

Analysts

• Biren Amin, Analyst at Piper Sandler
• Jon Wolleben, Analyst at Citizens
• Lisa Walter, Analyst at RBC Capital Markets
• Tara Bancroft, Analyst at TD Cowen
• Tazeen Ahmad, Analyst at Bank of America
• Truman Dunkley, Analyst at William Blair
• Yang Long, Analyst at Raymond James
• Yi Chen, Analyst at H.C. Wainwright