Eyepoint at Barclays Healthcare: DURAVU’s Market Promise

On Wednesday, 12 March 2025, EyePoint Pharmaceuticals (NASDAQ: EYPT) presented at the Barclays 27th Annual Global Healthcare Conference, highlighting strategic advancements in their lead product, DURAVU. The company emphasized its robust financial position and promising clinical progress, tempered by the challenges of a competitive market landscape.

Key Takeaways

• EyePoint’s DURAVU trials for wet AMD are progressing with 60% enrollment, aiming for full enrollment by late 2025.
• The company plans a Phase 3 trial for DME in 2026, with FDA discussions slated for mid-2025.
• EyePoint’s financial health is strong, with cash reserves expected to last until 2027.
• DURAVU’s sustained-release mechanism offers a competitive edge, potentially reducing injection frequency.
• Management remains optimistic about DURAVU’s market potential, targeting significant market share in wet AMD.

Financial Results

EyePoint reported a solid financial position with cash and cash equivalents ranging between $370 million and $400 million. This cash runway is projected to support operations well into 2027, beyond the anticipated data readout from the Phase 3 wet AMD trials. The company has committed to refraining from equity market fundraising this year, focusing instead on cash conservation.

Operational Updates

EyePoint’s ongoing Phase 3 trials for wet AMD, known as Lugano and Lucia, are advancing with rapid patient enrollment. The Lugano trial achieved 60% enrollment by mid-March 2025, with both trials expected to be fully enrolled by the second half of the year. The trials, conducted across 130 active clinical sites in the United States, aim to expand to 220 sites worldwide.

Future Outlook

Looking ahead, EyePoint is preparing to meet with the FDA to align on the design of a pivotal Phase 3 trial for DME, with a potential start in 2026. The company is considering trial designs that could demonstrate non-inferiority or superiority to existing treatments. DURAVU’s unique sustained-release profile is expected to offer a significant advantage, particularly in reducing the frequency of injections required by current therapies.

Market Opportunity & Competitive Landscape

The wet AMD market, valued at $10 billion in the United States, presents a substantial opportunity for DURAVU. EyePoint’s initial market research suggests potential market penetration of 25% to 40%. The company aims to capture a significant share of the market, leveraging DURAVU’s sustained-release mechanism. Despite the emergence of biosimilars, EyePoint believes DURAVU’s differentiated profile will maintain its competitive edge.

In conclusion, EyePoint’s presentation at the Barclays conference underscores its strategic focus on advancing DURAVU through clinical trials and securing a strong market position. For a detailed account, please refer to the full transcript below.

Full transcript - Barclays 27th Annual Global Healthcare Conference:

Balaji Prasad, Senior Analyst: Good afternoon, everyone. My name is Balaji Prasad. I’m the senior analyst for the specialty pharmaceutical sector. Continuing our spec pharma track for the day, we have with us the management team from EyePoint. So we have Jay Rucker, the CEO and George Elston, the CFO.

Jay and George, thank you so much for joining us today. I know you had multiple meetings since morning, and I hope it’s been a productive day for you.

Jay Rucker, CEO, EyePoint: It has. Thank you very much for

Balaji Prasad, Senior Analyst: the invitation. Great. Maybe just kick start the proceedings. Could I request you to provide an overview of the company and background, a bit of background

Jay Rucker, CEO, EyePoint: on the technology? Sure. So EyePoint is the leader in drug delivery to the back of the eye with four FDA approved products using our DuraSert technology. Our lead product is called DuraSert. DuraSert is the small molecule tyrosine kinase inhibitor, virolinib in our DURASERTE technology, E for erodible.

Unlike the four prior approval products, the products in DURASERTE are fully bioerodible. DURAVU has been in four trials so far including a very positive Phase II wet AMD trial that was called DAVIO2. That trial and its success in trial design has really guided our current Phase three protocols. We are two active Phase three protocols, identical global trials that are near simultaneous and are actively enrolling in wet age related macular degeneration. In addition, we have data from diabetic macular edema Phase two that we recently reported that we’re very excited about because our drug to review showed excellent visual acuity improvement, concomitant anatomic improvement.

And interestingly and most exciting is the improvement occurred very early within four weeks of administration of the drug. So we’re very excited about the potential of DME, which is another potential multibillion dollar indication.

Balaji Prasad, Senior Analyst: Thank you, Jay. Great to hear that. Maybe starting with VetAMD, the larger market, help us understand the design of the wet AMD registrational trials, both the Ligand and the LUCIA studies and what are the primary endpoints that seem to demonstrate?

Jay Rucker, CEO, EyePoint: Sure. So wet AMD is about a $10,000,000,000 market currently in The United States and growing. There are multiple ligand blockers that are biologics that are approved. And longevity is important to both patients and doctors. The ability to successfully go longer between visits and injections without risking vision is important.

And that’s really our value. DuraView should last a minimum of six months in virtually all patients. And studies indicate that by nine months the drug is really fully eluded from our insert. So the pivotal trials are designed around a non inferiority endpoint. Non inferiority is the way the last five approvals in wet AMD have been achieved.

And so it’s a tried and true approach to FDA approval. The primary endpoint is non inferiority change in visual acuity against an on label EYLEA two milligram control group. So the study is enrolling both previously treated wet AMD patients and treatment naive wet AMD patients. The ratio is going to be at the end about seventy five percent naive. All patients have to have active wet AMD, which means they have to have decreased vision.

They can’t have perfect twentytwenty vision to be enrolled and they have to have signs of exudation, which means they have to have fluid on this OCT examination that’s done. Patients are then randomized on day one to either DuraView two point seven milligram dose or the EYLEA control. All patients then receive a full load of EYLEA, which means monthly injections starting on day one, week four and week eight. At week eight, thirty minutes after the EYLEA, they either receive their first dose of DIRUVUE two point seven milligrams or they receive a sham injection for masking. Patients are then evaluated monthly.

Every other month the EYLEA arm gets another EYLEA. And at that same time the DERAVU arm will get a sham injection for masking. At six months after the initial DERAVU, the DERAVU arms will get a second injection. The primary endpoint is non inferiority change in visual acuity between day one and weeks fifty two and fifty six averaged. That will be sufficient at that point for us to put in our NDA.

The FDA has allowed the one year submission of the data, but our studies will both go on for two years for safety. And in the second year, nothing changes in the sense of the treatment protocols that will be the same. So the first trial is called the Lugano trial. The second trial is called the Lucia trial. And again, they’re essentially identical trials.

First patient dosed in the Lugano trial was dosed in October and we are now sixty percent enrolled in the trial. First patient dosed in Lucia was about six or seven weeks later and that trial is ramping up nicely and the curve of enrollment looks very similar to what we’ve been achieving with Lugano. So there’s been really outstanding patient and investigator interest in this trial. We set very high bar for enrollment and we’re breaking through the bar. And so we’re literally enrolling at rates in so far in Lugano that we haven’t really seen before in wet AMD trials.

So we’re guiding to have full enrollment in both trials by the second half of this year, which gives us data, top line data in the second half of twenty twenty six, both trials. I certainly think as you look at our enrollment, it’s possible that Lugana will finish enrollment prior to the second half of the year, but we will certainly keep updates going to inform when we have a little more daylight on exactly when the enrollment will be complete. So the feedback has been great from patients and from the investigators and we’re just very pleased about how these trials are enrolling.

Balaji Prasad, Senior Analyst: Got it. Great. Those are excellent updates. And as you commented upon the enrollment, let’s start there. So, yes, we saw that we announced a 30% enrollment in January, ’50 percent in Feb, and I will dive hard to see if you had not mentioned it as to what it is at mid March.

So we’re at 60% now. We are. So what’s driving this rapid enrollment? So a lot of

Jay Rucker, CEO, EyePoint: things and I don’t think I could name them all, but I’ll name some of the big ones. I think the primary thing is that we did a very large Phase two trial and it showed both safety and efficacy. And that’s really what gives doctors comfort in getting a patient to enroll in a trial that there is a good chance that the drug if assigned to that drug arm will work. And also there’s been really no safety signals at all. We’ve been injected over 190 patients with our drug so far with no ocular or systemic SAEs reported due to the drug.

And there really are no trends of any kind of AEs that were not unexpected from an injection. So the safety looks really good. The other in general reasons why we’re doing well is that we did a very comprehensive Phase II trial. We had 70 centers in that trial. So we had a great deal of doctors who knew about our drug, knew about the trial and were very easy to get them to roll into the Phase three.

But we learned a lot of lessons about how to enroll a wet AMD trial in the Phase two. And we got a lot of good feedback and we’ve taken a lot of those lessons to heart and I think that really has made the trial very attractive to both doctors and patients. I think the historic enrollment that you’re seeing though I’d like to say it’s all due to our great drug and great data. But there’s another reality out there, which is there are a lot of very professional retina centers throughout The United States and throughout the world that know how to enroll trials now. I don’t think that was true six, seven years ago, but it’s certainly true now.

And I think there are a lot of very high volume enrolling centers that we’re taking advantage of.

Balaji Prasad, Senior Analyst: Got it. And as you speak about the retinal centers, remind us how many clinical sites have been activated across the trials versus your overall Across

Jay Rucker, CEO, EyePoint: the two trials, it’s about 130 centers now have been activated. They’re all currently just in The United States. We would expect OUS centers, the first ones to come on in another month and a half or so. But this has all been done in The United States so far.

Balaji Prasad, Senior Analyst: And as for the trial protocol, how many do you plan

Jay Rucker, CEO, EyePoint: to activate OUS? We could activate up to two twenty sites worldwide. The way things are enrolling we may not get there because we may be fully enrolled before we have a chance. And it is a competitive trial. There’s no preset numbers on where the patients need to come from region or country.

And so that when we’re done, we’re done.

Balaji Prasad, Senior Analyst: Got it. And help us understand what the non inferiority margin as endpoint is?

Jay Rucker, CEO, EyePoint: Yes. So the non inferior margin for wet AMD trials in The United States has been traditionally minus 4.5 letters as the lower limit, which means statistically when you do a non inferiority trial, you have an actual numerical difference between your drug and the control group. In addition, there’s margins superiority and non inferiority margins above and below that are determined by the size of the trial in the standard deviation. And as long as your lower limit of the non inferior margin doesn’t cross minus 4.5 letters then your trial has been successful to the primary endpoint. We have that minus 4.5 margin given to us by the FDA at our end of Phase II meeting.

Balaji Prasad, Senior Analyst: Got it. Assuming things proceed well this year or next year between the enrollment and the top line and eventually we see a commercially commercial product. What kind of market opportunity or revenue opportunity are you looking at from the drug particularly?

Jay Rucker, CEO, EyePoint: Yes, it’s a great question. And we’ve started to do and have been really for the last two years doing early development of the market. We have a pretty good idea now if we were to roll the drug out now how that would be. We’ve queried doctors with a TPP that actually was worse than the TPP that we got from the Phase two trial. And in that initial querying of doctors, we got between 2540% market penetration with our drug.

Now our TPP from the Phase two looks even better than that. We’re repeating that quantitative data to see. But I would say that last week we heard at a couple of other meeting say that if the TKIs are approved they would use it in 80 of their wet AMD patients. So I think the idea that doctors are getting comfortable with is having a sustained release option that’s safe, effective, repeatable running in the background in most of their wet AMD patients. And if occasionally a patient gets fluid and needs a ligand blocker in between, there’s nothing wrong with that to supplement them.

I think based on our Phase two data, it looks like we should be able to take at least two thirds of the wet AMD population out six months or longer with our drug alone. But again, it’s not an either or situation. And because we’re a second mechanism of action, I think you can look at our DME data especially and say that may be advantageous. And doctors may want to take advantage of two MOAs in this disease. And again, I think that would be acceptable patients, doctors, payers especially if we can show advantages in using both an MOA of a ligand blocker extracellularly in a receptor blocker intracellularly.

Balaji Prasad, Senior Analyst: Got it. And I remember hearing when you call one of your calls earlier that you mentioned that you have around $370,000,000 4 hundred million dollars in cash and cash equivalents. So clearly looks like you have cash on wait till 2027. And so what is embedded in the guidance now other than DuraView and wet MD for the survey?

Jay Rucker, CEO, EyePoint: Go ahead, George.

George Elston, CFO, EyePoint: Yes. So our cash guidance includes completion of the ongoing Phase III’s with AMD. That’s really our focus. And when we had our earnings call last week, we guided that number one, we’re not going to the equity capital markets this year. We’re really conserving our cash and focusing the organization on completing those Phase III’s in wet AMD, which are really critical.

As Jay noted earlier, we’ll complete enrollment second half of this year and we’ll have the data readout roughly thirteen, fourteen months later. And our cash guidance is well into ’27, approximately a year on the

Jay Rucker, CEO, EyePoint: other side of data.

Balaji Prasad, Senior Analyst: Got it. And also could you talk about whether you currently have a plan to initiate a Phase III in DME at this point or at some point in 2026?

Jay Rucker, CEO, EyePoint: Yes, it’s going to be a 2026 event. We are preparing certainly from a regulatory perspective to meet with the FDA in the second quarter of this year to gain alignment on the details of the DME pivotal program. And we will be doing some things behind the scenes. We have that in the budget to do that. But as George said, we have no thoughts and interest in tapping the equity markets this year.

And therefore, we’re planning on initiating the pivotal trial or trials. We’ll see what the agency says for DME in 2026.

Balaji Prasad, Senior Analyst: Got it. And also as we look at the top line data and the Phase II results from the VIRONA program, I think there’s something which you’re discussing with the team. Seems like you removed one outlier in your supplemental analysis and BCVA improvement at twenty four weeks was 10 letters now. So help us understand the rationale of this.

Jay Rucker, CEO, EyePoint: Well, I wouldn’t say we removed the patient. We showed all the patients, all the patients in the trial with 27 patients finished the trial. And so we showed the complete data set. And at the end of the trial, we 24 all three arms of the trial, the high dose of DIRAVU two point seven milligrams, low dose of DuraView one point three milligrams and the EYLEA control all ended up with a seven letter improvement. Embedded in that however was a single outlier.

At week twenty, the DuraView arm had about a 10 letter improvement, but at week twenty four it dropped to seven letters because of this one outlier lost 23 letters. Turns out the outlier actually missed the twenty week visit and there what should have been their twenty week visit ended up being a twenty four week visit. So we didn’t eliminate from the full analysis, but what we wanted to show was without that outlier, our drug did really well. 10 letters improvement in the studies that got EYLEA approved for DME, there was about an eight plus letter improvement. So without that outlier, the improvement in our group in the high dose was terrific.

And the improvement was seen right away at week four, unlike EYLEA and DME, which takes months to show the improvement. And by month eight, it was a full 10 eight, sorry, it was a full 10 letters and that remained throughout the study. There was no drop off towards the end showing again that for most patients we do have a six month plus drug. The other important thing in this evaluation was the anatomy. The how drying effect did we show, what kind of drying effect on OCT.

And so even with the outlier, the drying effect on OCT was superior in the two point seven milligram arm to the control group. We also did a subgroup analysis of the eyes that made it the whole study in all three groups without any supplement. And again without supplement the unsupplemented eyes in the two point seven milligram arm gained over 10 letters compared to just three letters in the control group. So more evidence that when our drug worked in DME it worked really well and that potentially showing visual improvements perhaps even a little bit better than what you might see in EYLEA on label. Now if in fact we do a non inferiority trial design, we don’t have to beat EYLEA.

We only have to tie them or come close to tying them for the non inferiority margin. But obviously if we can show rapidity of action, if we can show the same visual improvement in four weeks that it takes four or five months for Eylea to achieve, I think that would put us in a very, very good spot in the marketplace.

Balaji Prasad, Senior Analyst: I mean, it’s a good point, good time to also just remind our audience as to what were the results with high dose Eylea or WAVESMO in tumor studies and what their non inferiority look like versus what you saw here? Yes.

Jay Rucker, CEO, EyePoint: So the non inferior margin for high dose Eylea versus regular Eylea in the wet AMD trial, the high dose Eylea was 1.4 letters worse than regular Eylea. It’s not something that obviously the company or even the KOLs make a big deal about. And the reason is non inferiority is non inferiority, the drug is approved. But there is an important point there, which is patients don’t really notice one or two letter loss. And as a result, doctors for more longevity are willing to sacrifice that level of vision.

Hence, their use of Vabasumone and high dose EYLEA where clearly if you use these drugs monthly, you’re going to get a little better visual result. But it’s just not practical to bring patients in that often. Even within every two month regimen, too many patients are lost to follow-up, too many patients lose vision because they can’t complete what they need to do. And therefore, a sustained release option with forced compliance over six to nine months, we think will be a really, really good innovation.

Balaji Prasad, Senior Analyst: Got it. And you help me understand the non inferiority and the endpoints on the Lugano side. So with the VIRONAV study, so at least forty three percent of patients had achieved absence of DME by week twenty four. So help us understand how do you define the absence of DME here? So lack

Jay Rucker, CEO, EyePoint: of DME for that study was defined as three twenty five microns on the OCT or less. So normal spectral domain OCT thickening of the macula is about 300 microns. Anything more than two standard deviations, which is about three twenty would be abnormal. So anything below three twenty five was considered to be no DME. That was a pre specified endpoint.

And so for the as you said for the eyes that had no rescue, about half of them in the DuraView arm ended with no DME. None of the unrescued eyes in the control group had no DME.

Balaji Prasad, Senior Analyst: Got it. So with this data that you have on hand, how are you thinking about the path forward in DME? And what are your plans to meet the regulators both in The U. S. And Ex U.

S?

Jay Rucker, CEO, EyePoint: So the path forward, I think, we know what we’d like to see. And again that would be a single trial. And I think we have some precedent to now suggest that in the second indication of DME, the agency may be agreeable to just one trial. Traditionally, it’s been two trials after the first two indications. That would obviously be very helpful to us.

We are still internally debating the structure of the trial that we want to run whether it would be a non inferiority trial or perhaps even a superiority trial based on the results. The other thing that we learned is our drug we knew from a preclinical that our drug worked fast. But I go back to the four week results with a single injection of EYLEA and our drug we got excellent results within four weeks. So

Balaji Prasad, Senior Analyst: we

Jay Rucker, CEO, EyePoint: could consider doing a non inferiority trial against on label EYLEA two milligrams, but not do a full load in the DIRUVU arms, maybe just one injection. And that would again highlight the rapid improvement if it’s there, which we would think it should be and also allow us to do a shorter trial.

Balaji Prasad, Senior Analyst: Got it. The other thing which is happening in the world of the both AMD and DME is many of these will see waves of biosimilars. So how does that influence your program and both commercially and also as you speak to payers, how does it influence it?

Jay Rucker, CEO, EyePoint: It doesn’t really influence us at all because we can do something none of them can do, which is last six months or longer in the majority of eyes. So that in some ways the more the merrier. Again, for doctors out there who are doing these injections, it gets very confusing. How many anti VEGFs can you stock in your refrigerator? And so the biosimilars right now are less than 5% of the market.

Right. And with the price they’re charging without rebate in the prices now of Lucentis and two milligram myelaea approaching those, it’s not clear in the end how much of a market biosimilars will have in this space. That’s really up to the makers of those other branded drugs. Regardless, we’ve had meetings with payers and the payers are clear that if in fact we get a label they will pay for our drug. And that certainly the mathematics around reduced injection frequency, reduced costs related to that I think will add into what our average selling price will be.

I think if we show that we’re neuroprotective which is possible, if we show we’re anti fibrotic, we have improved visual acuity not just tie, but do better. Those are all reasons why we’d be able to get even more of a premium price. So we think we’re going to be in a very good position with both the market and payers.

Balaji Prasad, Senior Analyst: Got it. That’s an excellent update. Jay, thank you so much for your responses. Look forward to future updates on this and wish you the best.

Jay Rucker, CEO, EyePoint: Thank you.

Balaji Prasad, Senior Analyst: And hope you have a productive day at the conference too, George. Thanks very much and Greg.

Jay Rucker, CEO, EyePoint: So thank you. Bye bye. Thank you.

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