Ocular Therapeutix at H.C. Wainwright: Strategic Moves in Eye Care

On Wednesday, 13 August 2025, Ocular Therapeutix (NASDAQ:OCUL) took center stage at the H.C. Wainwright 5th Annual Ophthalmology Virtual Conference. The company shared insights into its clinical programs and strategic plans, highlighting both opportunities and challenges. Key topics included their innovative product Axpaxli, potential market dominance, and financial strategies.

Key Takeaways

• Ocular Therapeutix is focused on Axpaxli’s potential superiority label in wet AMD.
• The company is expanding its focus to include diabetic eye diseases, with promising results from the HELIOS study.
• Financial guidance extends to 2028, but does not yet include costs for new programs.
• Top-line data from the SOAR-1 trial is expected in 2026, with the SOLAR trial following in 2027.
• An upcoming Investor Day on September 30 will provide further details on diabetic eye disease programs.

Financial Results

• Cash Guidance: The company’s cash reserves are projected to last until 2028, excluding new program costs.
• Revenue Expectations: Axpaxli is positioned for premium pricing due to its potential superiority label.
• Manufacturing Investment: Investments in automation and real estate aim to scale up production capabilities.
• R&D Spending: The Special Protocol Assessment (SPA) is expected to streamline FDA filings, reducing costs.

Operational Updates

• SOAR-1 Trial: Data is anticipated in 2026, with strategic patient selection to achieve superiority.
• SOLAR Trial: Enrollment has been reduced to 555 patients, with results expected in 2027.
• Manufacturing Capacity: A closed-loop process in Bedford, Massachusetts is being expanded.
• Regulatory Alignment: Protocol amendments were made with FDA approval.
• Investor Day: Scheduled for September 30, focusing on diabetic eye disease advancements.

Future Outlook

• Label Goals: The company aims for a superiority label for Axpaxli in wet AMD.
• Clinical Expansion: New indications for NPDR and diabetic macular edema are being pursued.
• Market Position: Ocular Therapeutix seeks to establish Axpaxli as a leader in eye disease treatment.
• Payer Engagement: Efforts are underway to demonstrate Axpaxli’s potential to reduce healthcare costs.

Q&A Highlights

• Protocol Amendments: Changes to trial protocols were aligned with FDA guidelines.
• Rescue Rate: The SOAR-1 trial’s rescue rate aligns with expectations.
• Hydrogel Safety: No safety issues have been reported with the hydrogel technology.
• NDA Submission: Expected after positive SOAR trial results, using the 505(b)(2) pathway.
• Payer Receptiveness: Positive expectations for payer acceptance of six-month TKI treatment.

For a deeper dive into Ocular Therapeutix’s strategic plans and clinical developments, refer to the full conference call transcript below.

Full transcript - H.C. Wainwright 5th Annual Ophthalmology Virtual Conference:

Unidentified speaker, Host, HC Wainwright: Good afternoon, and welcome to the HC Wainwright fifth Annual Ophthalmology Virtual Conference. For this session, we’ll have a fireside chat with doctor Praveen Dugal, executive chairman, president, and CEO of Ocular Therapeutix. Welcome, doctor Dugal.

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Thank you so much. An honor to be here. Thank you for including us.

Unidentified speaker, Host, HC Wainwright: I understand Ocular recently amended the phase three SOAR one trial protocol. I think it was in first quarter. And also amended the rescue criteria in the phase three SOAR trial. Could you tell us the rationales behind these amendment, whether all amendments are in alignment with the FDA, and what impacts would these amendments have on the pivotal program and the regulatory pathway?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Yeah. So thank you for again, thank you for having us here, and thank you for the questions. So the one thing that you need to know is that I I totally understand that whenever there are any kind of changes, it causes anxiety. But what’s really the question to be asked is what you just asked, which is are these changes done in alignment with the regulatory agencies? And, you know, what I will tell you is look back at our behavior, look back at our pattern, we don’t do anything, I mean, anything without absolute alignment with the regulatory agencies.

You just saw yesterday that we announced a spa for a non proliferative diabetic retinopathy study. I don’t know if there’s any group, of our size or a company of our size that has more alignment with regulatory agencies than we do. We don’t move without regulatory blessings. So every single thing that we do, including everything that you mentioned, is with regulatory blessings. So, if you’d like, I’m happy to go through the two amendments or modifications that we have.

Again, entirely in line with the FDA’s collaboration. So the first one that we have that we announced a few months ago was that of the SOL-one and SOLAR. And what we announced at that time was that we have agreement with the FDA that we can extend SOL1 to its second year with dosing every six months. And what that allows us to do is to use those patients to satisfy the FDA safety requirements. And what it also allows us to do is to reduce the size of SOLAR by a third from 825 patients to 555 patients.

And with the FDA’s blessing, we’ve also said that we’re gonna keep the data mass for twelve months, allowing us the possibility of including twelve month data, in our label. So we have now the possibility of having, what I really consider the holy grail of labels, which is a superiority label with the flexibility of dosing of every six to twelve months. And that’s the strategy. And not only that, but with the FDA’s guidance, we are now in a position to get to filing faster and cheaper because, remember, you need two studies. So we’ve now reduced the size of SOLAR by a third.

So, again, we get to the finish line faster and cheaper. And the way you know that we have complete FDA alignment is that we’ve done all this while maintaining the SOP. I mean, just think about that. That’s how if if I mean, that’s how you know we have total FDA alignment because we’ve maintained the spine doing all this. It’s a win win win for us.

Now moving to the most recent announcement, what we said was we’ve changed the rescue criteria or modified the rescue criteria. And let me explain what that’s not due to because I just wanna make sure that the counter narratives are addressed. It is not due to anything that we see in Solar. It’s way too early to see anything in Solar. As you recall, Solar has a very long ramp, intentionally so.

So it’s not like we saw something in SOLAR and made this change. There’s really nothing to be seen in SOLAR. The second thing to realize is that, yes, the FDA is completely aware of of these changes. We’re in total collaboration with the FDA, and this was done by us for strategic reasons only. And I’ll explain that.

The third thing that I will tell you is that this in no way jeopardizes the integrity of the SOLAR data. No way jeopardizes the integrity of the SOLAR data. I would not assume that anybody has been rescued in SOLAR. We never said anything about that. So it doesn’t jeopardize anything.

So why did we do this? There are three reasons. The first reason is when we designed this study, we wanted this study to be in several countries and several regions, and people in different areas feel comfortable about rescue with different formats. So we wanted to go out of our way to provide a a study that would be acceptable to all regions where rescue would acceptable to all regions. We so we included a number of rescue criteria.

We announced one, which is a 10 letter loss. We didn’t announce the rest. But it so happened that, look, it just became way too complicated and unnecessary. Our PI said, look, this is just not necessary to have all these rescue criteria. And at the end of the day, what we’re convinced is that the criteria that we have now is really gonna be no different than what we had before.

We don’t expect a single more or less rescue based on this change. That’s one reason. The second reason is very simple. We have a patient selection that is second to none, a six month ramp, with a a total of five loading phases or loading injections, two opportunities to observe the patient for any kind of instability before randomization. These are the most stable patients possible that you can randomize.

And in a non inferiority study, that’s exactly what we want. So we came to the conclusion that we want comparisons with other studies, either ongoing or those that have already been concluded. We invite those comparisons. Because in a non inferiority study, what happens is people look at at the visual acuity and they look at the number of rescues. And because we’re randomizing these rock solid patients, we believe we will beat all rescues.

So we want that comparison. So we wanted an apples to apples comparisons comparison with previous studies and ongoing studies. We invite that comparison because we’re so confident that we will do better. And the third reason is simply that we wanted to be aligned with OUS regulatory agencies. And we didn’t need to have an unnecessary conversation based on rescue criteria that that they hadn’t seen before.

So we said, look, we’ll use the same rescue criteria that you already are familiar with, that you’ve approved products with, and we’re happy to do that. So for those reasons, we made this change. It was a strategic change, and I think that now that’s been well recognized by the Street.

Unidentified speaker, Host, HC Wainwright: Thank you. That’s very helpful. If I understand correctly, the current expectation is to report top line data from SOAR one in 2026 and then top line data from SOAR in ’27. Could you remind us the primary endpoints of each trial and your expectations for the data readout based on existing clinical evidence of EXPEXLY?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Yeah. Thank you. Again, for SOLO-one, you’re exactly right. We we’re expecting the car turn in the 2026. And as you know, the primary endpoint is at month nine.

These modifications that that we just discussed have not changed anything, have not changed the primary endpoint, have not changed the powering. The SPA still remains. Again, evidence of FDA blessing here. The SPA still remains. And the primary endpoint is the proportion of patients who maintain vision at month nine, loss of vision or rescue per criteria defined as 15 letters or more 15 letters traditionally with the FDA because that represents doubling of the visual angle.

As far as SOLAR is concerned, SOLAR is a non inferiority study. We did give ourselves quite a bit of leeway and said the 2027, you’re absolutely correct. Is a non inferiority study with a non inferiority margin that is the largest that the FDA allows, which is 4.5 letters of vision. What’s very, very important also is the primary endpoint. The primary endpoint is a single primary endpoint.

It is not again, I gave it a repeat, it is not blended. It’s at fifty six weeks, and that is two months after the last axataxaly injection and the last Eylea injection. We believe this is that it this is an optimal singular primary endpoint for us. Again, I I ask you to look not just at the patients who are randomizing because I don’t think that there’s any study that I know of where patients have been so super selective to be derisked as this study. But I also ask people to look at the primary endpoint, which I think is very favorable to us and a very, important derisking factor.

Unidentified speaker, Host, HC Wainwright: Has the data and safety monitoring committee reviewed the masked data from both trials?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: So the data safety monitoring committee exists in both studies, and they constantly, on a regular basis, review safety data. I I wanna add that there’s been absolutely no safety issue with this drug. Again, wanna repeat that. There’s absolutely been no safety issue with this drug. None whatsoever.

There still hasn’t been there have been no indications from the data safety monitoring committee whatsoever regarding safety, and we don’t expect any safety issues whatsoever, period.

Unidentified speaker, Host, HC Wainwright: Mhmm. Is the rescue rate in SOAP one trial in line with expectations?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Yes. It is. I’ve said this, over and over again that what we look at in a mass fashion, and I wanna emphasize that we are completely and totally masked to protect the integrity of the data. So we’re looking at patterns. Right?

And there are three things that we’re looking at careful Under masking, one is the number of rescues, that’s what you referred to. The second is the cadence or the pattern of rescues, which is also very important. Are the rescues occurring when we expect them to occur? And the third is, are the rescues being done on protocol? And I’ve said this over and over again from from the from, I think from January onwards, which is to say that when we look at these three parameters, we are absolutely thrilled with what we see.

So the answer to your question is it’s not just that the number of rescues are within expectation or or according to our expectations, which is important. But I’m going further than that and telling you that the pattern of rescues as well as the fact that the rescues are on protocol are also, something that gives us a great deal of confidence.

Unidentified speaker, Host, HC Wainwright: Got it. Thank you. Could you tell us whether both trials, have only enrolled treatment naive patients?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Yes. It’s treatment naive it’s it’s it’s treatment naive patients since for a simple reason. We wanna have as pure a a a sample size as we possibly can. And it’s not just that this treatment naive patients, but it’s also and we have talked about this earlier on, and I’m happy to talk about this. And I think this is this is something that I talk about all the time, but I still think is very underappreciated.

I I think when people look back at these two trials, they will look at these trials as as really, trials that set the trend for future trials for thoughtful sponsors, not only because of the way they’re designed in terms of having complementary trials, not repetitive trials, but also in terms of the patient selection. The patient selection being bespoke for each trial. And one for a superiority trial with patients that are anti VEGF dependent and, designed to fail once, right, as a superiority trial and so one. And the other is patients that are specifically selected for stability, which is what would be derisking in a in a non inferiority trial. And I think those things have been done more thoughtfully in these two studies, than any study that have been associated in the last thirty years that have been doing this.

Unidentified speaker, Host, HC Wainwright: Thank you. I’m curious. When you report data from SOAR trial, will you report data from the aflibercept eight milligram arm as well, or does that arm only exist for masking purposes?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Yeah. I think that’s a great question, Yig. So the answer is I don’t know. It’s a little bit early, but I appreciate your question. You know, look, what we have done is to do everything according to the FDA’s guidelines.

You know, when people talk about risks, you know, people talk about risks when we change things or we modify things, you know, they kinda miss the forest for the trees. The question to be asked is, are you doing everything per the FDA guidelines? If we’re modifying something with the FDA’s blessing, there’s really very little risk or no risk at all. We’re doing it according to the FDA’s guidelines, period. And just like that, we’ve done every single thing in both trials according to the FDA’s guidelines.

That is why we have such great collaboration. And you’ve seen that over and over again, even to studies that we have yet to begin, such as the nonproliferative diabetic retinopathy study. But to answer your question directly, the the third arm, the high dose Eylea arm, per the FDA’s guidelines, is a masking arm. We don’t have any sham per the FDA’s suggestions and requirements for proper masking. And that is a pure numeric analysis.

The FDA doesn’t really care. It’s not a statistical analysis, and it can’t be because the randomized rate randomization ratio is two, two and one. It is a numeric analysis that we will have, and we will use for strategic advantage in terms of commercializing our product, and I believe that that will be a very big and unique advantage for us.

Unidentified speaker, Host, HC Wainwright: Got it. Got it. So XPaxley is based on the, hydrogel technology also utilized for the commercialized DEXTENZA product. Is that correct?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: That is correct.

Unidentified speaker, Host, HC Wainwright: Okay. Is there any safety concern associated with the hydrogel for redosing at six months?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Yeah. I’m glad you’ve asked that because the fact of it is there’s absolutely none, and we have experience with that in our earlier phase studies. But this hydrogel has been has has been used systemically. It’s being used systemically in over five million patients or so. And there’s just no safety issue, period.

I mean, I don’t know how else to say it. I mean, this is the reason why because is this a reason why we can confidently say that safety is just not a concern for us. And as far as, you know, doubling up this concern in terms of redosing, we’ve done that in our previous studies and we’ve seen absolutely no concerns. We expect zero concerns. Please realize, it’s not just that there’s no safety issue, but there’s nothing left behind.

There are no carcasses floating around. There when the drug is gone, the hydrogel is gone. There’s simply nothing left behind.

Unidentified speaker, Host, HC Wainwright: Got it. Can you tell us your estimated timeline for NDA submission and whether the five zero five b two pathway is applicable in this case?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: So as you know, the FDA, our FDA, has has, traditionally stated that they require two studies that hit the primary endpoint that are well masked, and we will provide that. And we will submit when we get positive results at week 56 in SOAR, which is our second non inferiority study. We expect to submit at that time. We believe that our submission will be very efficient based on several things. One of them you referred to, which is that we’ll be able to submit through the five zero five b two pathway, because we have a known molecular entity in our TKI.

And also remember that we have a SPA. And with a SPA, as I as I learned in my last company in iveric bio, that submission is extremely efficient because, most of the work has already been done in issuing the SAW. The statistical analysis of the and and all of that has already been approved and already been done. So we expect our submission to be very efficient indeed.

Unidentified speaker, Host, HC Wainwright: How do you expect expect expectly to be used in the real world practice among existing wet AMD therapies, including Lucentis, EYLEA, both of which now have biosimilars on the market, and also the Bismol, SUSVEMO, as well as the off label use of Avastin.

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: So it’s a great question, Ian. Thank you for that. I mean, look. What we intend to do is to have a superiority label, period. That will set us apart.

There is no superiority label in this field. There is not an active trial that I know of or even one that’s planned for superiority. And if we have a superiority label, we will be, in our opinion, immune from all the pricing pressures that exist right now. You know, right now, what you see is a morass of drugs that are me too drugs that may be incrementally this way or that way, but they’re pretty much all the same. So when that happens, as you know, there’s a race to the bottom.

And it’s a pricing pressure, it’s step therapy, all those things. What I will tell you is that with a superiority label, what you will see, is that we will be in a different orbit where we will have premium pricing with the potential for premium pricing with absolutely no such pressure whatsoever. Now if you ask your KOLs, does a superiority label mean anything to you? I guarantee you, they will say, you know, I never look at a label before I inject. And that’s what I used to say too, and they’re right.

But that’s the wrong question to ask your KOLs. The question to ask your KOLs is, does it matter to you that you as a doctor get to decide what drug your patient gets? Does it matter to you, you as a doctor, that you can start that your patient on the drug that you want right away without having to wait until the patient fails on a lesser drug and perhaps has irreversible, loss of of vision. Every single KOL will say yes. And the fact of it is that’s they get that because of the superiority label.

Because they don’t have the pressures of step therapy, they can choose the drug, They can go to the premium product. And for those who look at our company and value our company, believe me, a superiority label, the only one, insight and the only one of its kind matters a lot in terms of the valuation of our company.

Unidentified speaker, Host, HC Wainwright: Got it. Can you talk about your current manufacturing capacity for xRaxoline?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Yeah. One of the things that I’m very proud of in this company, which I didn’t have, in in the last company is that, look, we have a closed loop where we manufacture, where we have a commercial team, and we’ve proven that we can scale up. Right? We can we manufacture ourselves. It’s done in Bedford, Massachusetts.

We’ve scaled up before. We’ve demonstrated that we can do that with DEXTENZA. And I’m I’m I’m I’m grateful to you that you asked that question because the fact of it is we’re investing a great deal, in terms of real estate, in terms of automation, in terms of the manufacturing, and we’re absolutely geared up to scale up for the demand that will be there for ex Paxil.

Unidentified speaker, Host, HC Wainwright: And how receptive do you expect the payers to be for a six months TKI treatment for wet AMD?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Yeah. Again, a great question. You know, this is one of those drugs that’s a win win win for everybody. You know, if you look at the payers, think about the fact that in this country, and that’s in The US, right? I mean, you know, maybe the best health care anywhere, Forty percent of patients drop out in the first year.

Forty percent of patients, almost half. Now they drop out of coming to get treated. They don’t drop out of the health care plan, and they go blind. And having been on boards of of a couple of, payer companies, I’ll tell you, the most costly patients are patients who are blind. It’s because their mortality doesn’t change, but their use of resources skyrockets.

Right? So if we can go to the payers as we are doing now in terms of, the SABs and and our payer advisory boards and say, you know, if we can reduce the dropout rate by even ten percent and and have a quarter million less patients go blind in this country alone? A quarter million? Is that interesting to you? Of course, is.

The savings that they will have is enormous. Patients will win. Payers will win. So what does that mean? That means that we can price the drug at a premium.

It also means that doctors will benefit because now doctors will have a better drug with a greater encatchment of patients so they can inject as much as they want. More patients will benefit. It’s not just the same patient. They’ll just have a greater encatchment of patients. They won’t have to buy a single piece of new equipment.

Their workflow doesn’t change at all. They’ll simply reach out their hand and get a better drug and have a higher ASP. And economically, again, it’s a win win win for for for payers, for doctors, and it’s a better outcome for patients.

Unidentified speaker, Host, HC Wainwright: Got it. Got it. So you mentioned the for the NPDR indication, there is another SPA, special protocol assessment with the FDA. But what about the diabetic macular edema indication? Do you plan to pursue both indications concurrently in the future?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: So, again, I go back to this, and I think the question to be asked is why did you get an SPA? Right? I mean, you know, I I I think we may hold the record of of companies, in the size of our companies with a number of SPAs and and and FDA collaborations. And it’s simply because of that. I mean, people, you know, have these false narratives that, wow, they’re changing stuff in the middle of this.

Are they are they going off the reservation? Again, I I I wanna make sure I mentioned this. We don’t do anything, anything without the FDA’s blessing. And we seek the FDA’s blessing. We seek their collaboration.

And this is why we got an SVA for a study that we haven’t started yet, and we won’t do it without an SVA. Alright? And and this is how dedicated we are to working closely with the FDA with every single thing we do. So we don’t do anything at risk. And the answer to your question is when we look at the HELIOS study, the results were absolutely remarkable.

I mean, remarkable. Every single parameter was in favor of the drug. And the more and more we look in, you know, with the studies that Justice Ehlers has done in the Cleveland Clinic and others, the more confidence we get in a single injection of this drug having remarkably beneficial effects after forty eight weeks. To the point where if you look at the control, they behaved exactly as you would expect them to behave. Right?

What you expect with the natural history is that thirty to forty percent of patients will have vision threatening complications year upon year. And sure enough, in the control arm, it was thirty seven point five percent, exactly what you would expect. With a single injection of XPax, like, at week forty eight, it was literally zero. Zero. I mean, literally zero.

And we’re clinicians here. And when we looked at this and said, holy cow. What we can do is to have a conversation with our patient and say, you know, if you come to see me once a year, I can reduce your vision threatening complication, your blinding complications from thirty percent to forty percent year upon year to literally zero. I mean, that’s like going to the dentist for a teeth cleaning every year. I mean, that is remarkably powerful.

So we have to do this study. It’s it’s there sitting for us, and now we have a spot. This study is going to be fantastic, you know, from our perspective, for patients, for us. The other part to your question is that, look, yes, we have patients with diabetic macular edema, non center involving diabetic macular edema. Every single one of those patients, every single one of those patients improved.

And yes, we intend to study that as well. So we haven’t detailed the study design, but we will in our Investor Day. I hope all of you will come there. It’s on the September 30. You can register on our website, and you’ll see the details.

And, yes, we intend to study not only non proliferative diabetic retinopathy, but also diabetic macular edema.

Unidentified speaker, Host, HC Wainwright: Got it. Thank you. Does Ocular currently have enough capital to complete a pivotal program in what MD, obtain regulatory approval and commercially launch expected?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: So, you know, look. What we’ve said is that our cash guidance runs into 2028, and we’ve been very conservative in saying that with additional monies that we got in from the ATM, we have not changed our our our guidance because we’re ultra, ultra conservative. We’ve also made it a point of saying that that does not take into account the OLE or the NPDR, program that we will outline, in our Investor Day.

Unidentified speaker, Host, HC Wainwright: Got it. So we are getting to the end of the chat. Could you provide a summary of the upcoming catalyst and maybe some closing remarks for our audience?

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Absolutely. So upcoming catalysts, you know, look, what you’ll see, again, I hope in Investor Day is and I hope, again, all of you attend either in person or virtually, I think you will see a very, very enthusiastic, and I emphasize enthusiastic and detailed outline for our program in diabetic eye disease. I I think that you will see a number of other cuts that we will see from our previous studies coming up. You know, obviously, the big catalyst that, that everybody is waiting for the part term for for SOAR one, and then and then SOAR. So there’s a lot to come, but mainly what you will you will see, and this is really the the closing part that I would tell you, is that we have now, we are now in a position of confidence based on the, of what we see on a mass basis and so on.

And we’re in the process very deliberately of positioning this drug to be dominant in the market, not just in wet macular degeneration, with a superiority label that nobody else is gonna have and nobody else will have in the foreseeable future where it’ll be in a different orbit for years, if not a decade or more. We’re also positioning drug this drug very deliberately, in diabetic eye disease. And together, what I think that will do is increase the value of our company greatly.

Unidentified speaker, Host, HC Wainwright: Got it. That’s very helpful. Thank you very much, doctor Dugald, for participating in our conference, and best wishes for your clinical development.

Praveen Dugal, Executive Chairman, President, and CEO, Ocular Therapeutix: Yves, thank you very much. I really am grateful for the opportunity to tell our story and for your invitation. It’s an honor to be here. Thank

Unidentified speaker, Host, HC Wainwright: you. Thank you.

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