EyePoint at RBC Conference: Strategic Insights into DURAVU Trials

On Tuesday, 20 May 2025, EyePoint Pharmaceuticals (NASDAQ:EYPT) participated in the RBC Capital Markets Global Healthcare Conference 2025. The company’s Executive Vice President and CFO, George Elston, provided a strategic overview of EyePoint’s current initiatives, focusing on the DURAVU program for wet AMD. While the company highlighted significant progress in its clinical trials, challenges remain in the competitive landscape and commercialization strategy.

Key Takeaways

• EyePoint’s DURAVU program is in two global Phase III trials, with the Lugano trial over 90% enrolled and LUCIA over 50%.
• The company plans to independently launch DURAVU in the US, with a focus on finding a partner for global commercialization.
• DURAVU’s novel mechanism of action positions it as a potential premium-priced treatment with six-month dosing intervals.
• EyePoint is well-funded, with cash reserves expected to last until 2027, supporting its strategic initiatives.
• FDA interactions have been timely, with no disruptions, supporting EyePoint’s regulatory strategies.

Financial Results

• Revenue and Earnings: Not discussed during the call.
• Cash Position: EyePoint has sufficient funds to reach its next data milestone and expects to maintain cash reserves into 2027.
• Potential Pricing: DURAVU’s six-month injection interval could justify premium pricing compared to existing treatments with shorter durations.

Operational Updates

• DURAVU Trials: The Lugano trial has exceeded 90% enrollment, while LUCIA is over 50% enrolled. Full enrollment for both trials is anticipated in the second half of the year, with data readout expected in the latter half of 2026.
• Manufacturing: DURAVU is manufactured in Massachusetts, with its active ingredient, Roland, produced in the US to mitigate tariff risks.
• Regulatory: The European Medicines Agency has approved the clinical trials in Europe.
• Commercialization: EyePoint aims to launch DURAVU independently in the US and seeks partnerships for commercialization outside the US.
• DME Program: An end-of-Phase-II meeting with the FDA is scheduled for early July, with a potential single trial starting by the end of the year.

Future Outlook

• Enrollment Completion: EyePoint expects to complete enrollment for both Lugano and LUCIA trials in the second half of the current year.
• Data Readout: Anticipated in the second half of 2026.
• NDA Submission: EyePoint plans to submit the NDA with 12-month safety and efficacy data, supplemented later with 24-month safety data.
• Commercial Launch: Plans to launch DURAVU in the US independently.
• DME Program: Expected developments in 2026.

Q&A Highlights

• FDA Interactions: The FDA has been responsive and timely, with no observed disruptions.
• Macro Issues: DURAVU’s US manufacturing mitigates potential tariff risks.
• Wet AMD Landscape: DURAVU is positioned as a novel treatment with a new mechanism of action, distinct from existing anti-VEGF therapies.
• Doctor Incentives: EyePoint believes doctors will prioritize patient benefits from sustained-duration therapies.
• Fibrosis: DURAVU may offer benefits in fibrosis management due to its mechanism of action.
• Dosing Intervals: Six-month intervals were selected based on feedback from healthcare professionals.
• Supplemental Injections: Criteria have been narrowed in Phase III trials to be very strict.

For more detailed insights, readers are encouraged to refer to the full transcript of the conference call.

Full transcript - RBC Capital Markets Global Healthcare Conference 2025:

Lisa, Analyst, RBC Capital Markets: Analyst here at RBC Capital Markets, and it is our great privilege to have EyePoint Pharmaceuticals joining us for a fireside chat. Representing the company, we have George Elston, Executive Vice President and Chief Financial Officer. George, thanks so much for joining us today. How are you doing?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Thank you, Lisa. Thanks for having us. We appreciate the opportunity to be here at RBC and talk about the exciting progress we’ve made at EyePoint. So looking forward to the discussion.

Lisa, Analyst, RBC Capital Markets: Excellent. Well, George, maybe just to kick things off, would you like to give us a brief overview of the company and maybe tell us where things currently stand with the pivotal trials for wet AMD?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Sure. So EyePoint at its core, we are focused on delivery of drugs to the back of the eye. We’re a drug delivery company at heart, and we really are excited about our program, DURAVU, which is in two global Phase III trials named Lugano and LUCIA that are actively enrolling. And we announced two weeks ago at earnings that Lugano was over 90% enrolled. That trial started last October.

Lucia over 50% enrolled. And we’re really thrilled with that progress. High Point has been a story about execution. And you look, we were just remarking recently, we dosed our first patient in our Phase I in 2021, and here we are in two global Phase IIIs. Our progress has been spectacular.

We’re well funded to get to our data point next year. And so our guidance is complete enrollment, both trials second half of this year and data readout from both trials second half of twenty twenty six with cash into 2027. So we are really in a great way.

Lisa, Analyst, RBC Capital Markets: Thanks for that, George. And maybe before we dive into the details of the pivotal studies, could you tell us maybe how your communications have been going with the FDA? There’s been a lot of changes there in recent weeks with workforce reductions and also the hiring of, the new commissioner, Marty Makary.

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So that’s a really good question. And, there’s a lot of discussion out there about FDA. I think fortunately for EyePoint and I think so far in the ophthalmology division, it’s been business as usual. We’ve seen no disruptions.

In fact, the agency has met or beat response times to us. We’ve recently went to them with an end of Phase II meeting book for our DME program and received all that communication on time and the of Phase II meeting scheduled for early July. So all on time so far. And even our program manager and the team involved with the DuraVu assumption, So it’s been business as usual.

Lisa, Analyst, RBC Capital Markets: Got it. That’s helpful. And I also want to touch on another macro point. There’s been a lot of discussion about the potential for pharmaceutical tariffs as well as conversations around most favored nation pricing. How is EyePoint kind of navigating all these almost like lightning fast changes that are coming down from the government?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So it’s been important for us at EyePoint. We feel we’ve been out ahead on this curve. So for example, DuraVu is manufactured at our brand new state of the art commercial facility in Massachusetts that was built to our specifications, and we can support global production out of that facility here in The United States. That team has done a remarkable job.

We had our open or I should say, our ribbon cutting last fall. We’re in the middle of registration batches. And so that team is laser focused on not on completing registration batches and being prepared for preapproval inspection. And Roland, of which is our active API for DuraVu is manufactured in The U. S.

So we’ve really been on ahead of that curve to make sure we’re in a good place there. I think from at least on the tariff side, I think most favored nations will see. We are a couple of years away from, hopefully, a potential launch, and so that will certainly be part of our calculation. We’ve been very public that we will launch this product in The U. S.

And bring in a partner for OUS. And I think that will become a matter that we’ll evaluate over the next week.

Lisa, Analyst, RBC Capital Markets: Got it. That’s very helpful. Well, maybe let’s talk about the wet AMD landscape. How is EyePoint thinking about this 15,000,000,000 market that’s currently dominated by the anti VEGFs? Where could DERVIEW fit in here?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So that thank you for that question. And I think importantly, DERVIEW is not another anti VEGF. And I think there’s a lot of discussion and I think that’s been the dominant the anti VEGF therapies have been the same treatment for the last fifteen or so years for that disease. We bring something very new.

We’re bringing a new MOA. We’re bringing a receptor binder, tyrosine kinase inhibitor that inhibits all isoforms of VEGF. We bind PDGF, which may have potential benefit on fibrosis. And even in our preclinical models, we showed potential neuroprotection. So our argument has always been that we are bringing something new.

It’s a new MOA. The history of the VEGF treatments is the newest treatment lasts a little bit longer than the prior. Use us, don’t use them. And our argument has always been use your VEGFs, keep your patients stable, put into review. If our Phase II data holds, we’ll be able to take twothree of patients or more six months or longer with vedipartinib.

So that’s how we think about it. We’ve positioned it as a maintenance therapy, second MOA, constant drug on board. And we’re not asking doctors to give up their VEGF, Use them with us, not instead of them.

Lisa, Analyst, RBC Capital Markets: Got it. That that that’s really helpful. You know, maybe one of the and and I’m glad you brought up how, how we think doctors are thinking about using DuraVu. One of the biggest pushbacks I often hear from investors is that doctors are financially motivated to give patients as many injections as possible, and why should they switch to a longer acting treatment if they’re gonna get paid less just because they’re doing fewer injection? What are your thoughts on this argument?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: So a lot of investors like to talk about that, but if you actually talk to doctors, that’s very different. Doctors are always going to do the right thing for the patient. And while, yes, I’m sure there are practices out there that love to inject, our argument to them is quite simple. We’re not asking you to stop injecting except every six months instead of aflibercept, put in a drug. And that’s going to give you that constant background protection, two MOAs on board.

It’s practice dynamics. And so we’re not the reality on the ground is most of these practices are jammed. They’re looking for reasons. They’re looking for duration. If you look at the success of BaBismo, they’re offering essentially eight days more, yet they’ve taken a massive market share.

And so there’s tremendous need within these practices to get more patients out on sustained duration therapies. And we think we’ve got a real nice opportunity.

Lisa, Analyst, RBC Capital Markets: And George, you touched on fibrosis earlier. The anti VEGFs obviously have been very successful at keeping eyes dry and we understand their view could help really solve patient compliance. But one thing that does not get as much attention is, the potential for sustained delivery treatment on fibrosis. Could you expand a little bit more on that? How could DERVIEW help there?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: So I think we’ll see this in the clinical data, but we there’s evidence out there that blocking PDGF is associated with fibrosis. The current anti VEGFs do not block PDGF. So I think we’ll see in the data that’s we the LuganoLucia trials are two year trials. And so I think we’ll have the opportunity to look at that at various time points when that data card flips at both the twelve month, and then we will continue treating patients for twenty four And we’ll see what kind of that’s to me, any fibrotic benefit is all upside. It’s certainly not on the path to approval.

Lisa, Analyst, RBC Capital Markets: Got it. Well, let’s talk about Lugano Leuchea. But first, I I I wanna touch on something else. Your remind us about your global regulatory strategy. You kinda touched on it earlier.

You’re seeking to launch solo in The U. S. Commercial ex U. S. With a partner.

But how are you thinking about, you know, dealing with the FDA, dealing with the EMA and dealing with other regulatory bodies?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So our regulatory team is, as you may know, both of our Lugana and NUCIA trials are global trials. So we have engaged broadly with regulatory authorities outside of The U. S. In fact, last week, we just learned from EMA that they’ve signed off on our clinical trials in Europe, which is a huge box check for us.

And we’ll be looking to activate sites in the EU. We think that’s a big hurdle. They are a bit of a tougher group to get through, and I think it’s good validation on our program, our CMC. And, again, that’s going to be helpful for a future partner. We will we’ve been very public.

We are not launching Veruviu outside of The U. S. We will do that with them.

Lisa, Analyst, RBC Capital Markets: Got it. And can you remind us, how did you come to choose every six month dosing intervals for Luviano and Lucia? The Phase II, the DAVIA-two study, the majority of patients didn’t need a supplemental injection at six months, but even nine months and twelve months. So how did you settle on a biannual dosing regimen for the pivotal study?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: That’s a really easy answer, and that is we asked, what do you want? These are high touch patients. They’re not going to let their patients go twelve months without seeing them. And so as we did our early evaluation on the program and the opportunity, six months was the sweet spot.

Lisa, Analyst, RBC Capital Markets: Got it. And maybe just on enrollment, we already touched on it in your opening comments. But looking back at Lugano, it looks like it took roughly four months to reach the halfway point of enrollment, but it has only taken two months to enroll, another 160 patients or so and and reach a 90% enrollment mark. A couple of questions on enrollment here. Is it within the realm of possibilities that Lugano could actually complete enrollment in the first half of this year?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: If you do the straight math, absolutely. I think our guidance for both trials is second half of this year. We’ve been really, excited and privileged on the robust patient and investigator enthusiasm for both programs. We think we present to doctors and patients a great opportunity with this program. All patients are getting treated.

We did a robust Phase II trial. They are informed, and we’re seeing that in the enrollment. I think we’ve it’s beating not just historical records for enrollment in wet AMD trials, but even our own projection. So the short answer is yes, but we’re not changing our guidance at this point. The straight math certainly supports it.

Lisa, Analyst, RBC Capital Markets: Got it. And maybe just on LUCIO, since this is over halfway enrolled, are you seeing an acceleration right now similar to what you saw in Lugano once you reach that halfway mark? Are you getting even more patients joining the trial?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: So we’ve seen pretty steady enrollment rates and screening rates, and our screen failure is actually doing better than we projected. We will have more international sites, certainly, in Lucia. And again, we’re seeing that same enthusiasm.

Lisa, Analyst, RBC Capital Markets: And one thing that we heard a lot about during Q1 earnings was that, you know, the underfunding of co pay assistance organizations were really impacting patient access to wet AMD drugs. But maybe on the flip side, could this actually be a good thing for companies like EyePoint who are trying to enroll their clinical studies? Is that something that you’ve noticed?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So the short answer there is we did anticipate a drop off in enrollment as the calendar flipped to 2025, and it was actually the opposite. We saw an acceleration in enrollment. And while the Good Days program, which a lot of the companies have referenced being coming into this year unfunded, not great for patients, but it actually was very helpful for our enrollment. If you’re thinking about your doctor, you have a patient in the chair, they’re facing co pays up to $400 per eye.

And the argument is, okay, I can you can go do your co pays or I can put you in this clinical trial where you’re going to get standard of care and the potential for a sustained delivery option. Plus, we’re also treating the fellow eye if it’s available. And so it’s a very easy discussion for doctors to have with patients. And I think while that fortunately, that program was not good for patients overall, I think it was helpful for our follow-up.

Lisa, Analyst, RBC Capital Markets: Got it. And maybe let’s just touch on, you know, the blinded supplemental injection rate. Is this something that you’re tracking? And is this in line with your expectations?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: So I’m sure someone is tracking. We at our executive level don’t see that. And again, it’s masked. So even if you don’t know which arm they’re going to be in. And so I think we’re going to wait for the full data set before we take a look at that.

I don’t think it’s going be helpful to look at that soon.

Lisa, Analyst, RBC Capital Markets: Got it. Well, one thing I’m always curious about, these are non inferiority trial designs. They’re kind of a tried and true, path to approval. The primary endpoint is is very well defined, BCVA at twelve months and non inferiority is a four and a half letter delta between the treatment and the control arm. But has the FDA said anything about what they’re looking for in terms of reduction in supplemental injections?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: So, that question has been lingering out there. We’ve had in all of our interactions with the FDA, there’s been no direct Obviously, supplemental injections is important. I think if you have a high supplement rate, you may not have a drug. Our Phase II data was very supportive. We had a very low supplement rate.

And in our Phase III, we’ve even narrowed our criteria, very meaningful supplement because what we saw in the Phase II trial, where we allowed investigator discretion is about 20% of the supplements did not meet any criteria. And then even deeper into that, when we looked at supplements, a lot of them had no effect vision. And so our Phase III, we’ve really narrowed that supplement criteria to be very strict, and that is five letter loss with 75 microns of new fluid or vision threatening hemorrhage. There’s no investigator discretion. We do have a safety media peers that they can reach out to if they would like to supplement, all with the premise to minimize supplement rates and really focus on maintaining vision.

Lisa, Analyst, RBC Capital Markets: Got it. And can you remind us, EyePoint decided to pursue a new 2.7 in a new formulation in the Phase III versus the Phase II, you had two doses, a two mg and a three mg. So I guess what gives you confidence that the new dose will perform in the pivotals just as well as the results that we saw in DAVI-two?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So I think first and foremost, same formulation, just higher payload insert. And actually, if you go back over time, we’ve actually studied a four forty micron insert, a one mg insert, now a one point three four mg insert. So in the Phase III, it’s two inserts, single injection getting to two point seven mg. If you look at the Phase II data from GAVIO-two, there was essentially no difference between the two mg and three mg doses.

And so we wanted to accomplish that with two versus three inserts, simple math, lower COGS, and it gets us from here to there. It’s also a much smaller percentage of the matrix as well. So we know that in about nine months, all of the drug is gone. And we’re essentially achieving that high dose that we saw in Phase II with two inserts.

Lisa, Analyst, RBC Capital Markets: Got it. And maybe just on redosing. Lugano, Lucia, this is really the first time that you’re going to be exploring redosing of Derview on a larger scale. What gives you confidence that redosing is going to be successful in terms of safety and efficacy in the pivotal study?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So, great question. So we are actually doing in the Phase 3s, are redosing every six months for two years. So there’ll be a total of four doses. Why are we doing that?

Because we want to label for every six month dosing. We’ll be submitting the NDA with twelve months safety and efficacy and then supplementing that with the twenty four month safety data. There’s no non inferiority margin for year two. We’re very confident in the at least in the preclinical work. We’ve done robust animal trials on dosing and redosing, and we’ve seen no dose limiting ox or number of inserts in animals.

And so very supportive. The agency has seen that and have signed off on that.

Lisa, Analyst, RBC Capital Markets: Got it. That’s very helpful. EyePoint is also exploring Derview in diabetic macular edema. So George, can you explain us the market opportunity here?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So in first quarter, we actually reported our twelve month DME data, which was really spectacular. We showed an immediate, and sustained benefit of DuraVu in DME patients. Like AMD, it’s an exudative disease and DURAVU or invrolin seem to have a really robust effect there. What we saw was really remarkable.

Essentially, week four, we had immediate separation from the upper sept arm. We had significant improvement in vision and associated significant reduction in fluid, and that was maintained through week 24. So doctors are very and we’ve been talking about this earlier today. We’ve guided the Street that DME will be a 2026 event. We’ve got the team laser focused on wet AMD execution.

We will have our end of Phase II meeting with the agency in early July, lay out that plan for potentially a single trial, but that won’t start until the end year. The medical community has got a very different approach. They’re very excited about the data and the program. Obviously, they want us to do trials yesterday. But where we sit today in these markets, we are, as a company, laser focused on what we do.

Lisa, Analyst, RBC Capital Markets: Got it. And what other indications are you thinking you could explore with DuraVu?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: So I think our plan right now is to execute on these two mass I mean, between wet AMD and DME, you’re looking at two multibillion dollar indications. Think with that data next year, we’ll look to explore other potential indications that a lot of the VEGFs will come back to. We’ll update that later.

Lisa, Analyst, RBC Capital Markets: Got it. Makes sense. Well, maybe let’s just talk a little bit about potential commercialization of of Derview. Maybe one on on pricing. Obviously, a little bit early for for this discussion, but from my conversations with investors, appears most are modeling Derview at a premium to the anti VEGFs.

Is that a fair assumption?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So I think if you just look at it, and again, to your point, it’s early. But if you look at it in simple terms of one DERVIEW replacing three six months versus every other one. And then there’s some HEOR benefits as well. So that could suggest a premium.

I think if our Phase III data supports potential neuroprotection, potential endometriosis, then there’s potential for premium above that. We again, it’s very important. We see neuro view as not another anti vedal. This is its own new category in the space, and we’ll be pursuing that marginally.

Lisa, Analyst, RBC Capital Markets: Got it. And how are you thinking about a potential launch? You made it pretty clear that in U. S, you plan to launch solo, ex U. S, seek a partner.

But what could a a solo launch in in The US look like? Have you shared your thoughts on what you would need for for a sales team? How many representatives you would need in the field? How many doctors, retina clinics you would need to approach? How should we think about that?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yeah. So, what’s unique about retina in The United States, at least, is that it’s a pretty small footprint. There’s about 2,400 retinal doctors in The U. S, and you could approach that with about 70 reps. So your commercial infrastructure is not that significant that you would need to invest in.

We acknowledge there are two very well funded, well entrenched players, and so marketing will certainly be a much bigger spend. But again, we are not directly competing with it. Are not asking doctors to stop using. And so we you may recall, EyePoint had a commercial product that we sold two years ago on YUTIQ, which were posterior uveitis. We’ve kept some key folks from our commercial team.

They’re doing a lot of this precommercial work, and we’ll be gearing up to invest in that organization on the other side of data. We are not against having a global partner in The U. S, but I think right now, we are full guns planning to launch this ourselves in the group.

Lisa, Analyst, RBC Capital Markets: Got it. And how should we think about you know, the conversation that, a sales rep might have with with a physician? So they’re they have doctors. They’re on wet AMD. The physicians are very used to to the anti VEGFs.

In the future, you’ll have your your phase three results. You’ll have your label. You can discuss that freely. But how do you think the conversation is gonna go, about talking about when to switch from an anti VEGF on to DERVOY?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Yes. So I think that you’re again, it’s early days and for the record, not a sales rep. So, I suspect, and we talk broadly about an A2B shift. Again, we are not asking doctors to give up with it. This is another MOA.

We’ve always talked about DuraVu as a potential maintenance therapy. Get your patient stable. If you look at our Phase III design, we’re doing three loading dose. Get your patient stable, put into review. If our Phase III I’m sorry, our Phase II data holds, we can take twothree or more patients six months.

And the discussion with doctors is we’re not asking you to give up your VEGFs. Now in those cases, if you go back and look at VALUE-two, where a patient showed a little bit of fluid, it resolved and they didn’t need another treatment. And then there are other cases where they showed some fluid, they got an anti VEGF, and they were fine for another six months. So we’re going to let data lead that discussion, but that’s how we think about the market.

Lisa, Analyst, RBC Capital Markets: And you had any conversations with payers about potentially supporting a patient who needs the anti VEGF and DERVOY at the same time?

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: So if you look at the current market right now payers reimburse every twenty eight day injections of an anti VEGF. We wouldn’t look to disrupt that, at least from that perspective. We’ve had early discussions with payers. We’ve had early discussion with a lot of these practices and more to follow. I think what’s interesting from a practice perspective is almost universal.

Their narrative is don’t slow us down. These are really active, robust practices where they’re injecting sixty, seventy, eighty patients a day. The beauty of DuraVu, we’re shipping at sort of room temperature. We’re not taking up refrigerator or freezer space, and it’s delivered in a loaded injector, and it’s going to fit right in there.

Lisa, Analyst, RBC Capital Markets: Got it. Well, George, I think that’s all the time we have for today. Thanks so much for joining us and we’ll see you next time.

George Elston, Executive Vice President and Chief Financial Officer, EyePoint Pharmaceuticals: Great. Thanks for having us. Appreciate the time. Thank you.

Lisa, Analyst, RBC Capital Markets: Thank so much.

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