EyePoint Pharmaceuticals at Leerink’s Conference: DuraView’s Promising Potential

On Tuesday, 11 March 2025, EyePoint Pharmaceuticals (NASDAQ: EYPT) presented at Leerink’s Global Healthcare Conference 2025, highlighting the promising potential of its DuraView drug delivery system. CEO Jay Duker shared a strategic overview, focusing on the company’s robust financial health and operational progress, while acknowledging investor concerns about stock performance.

Key Takeaways

• EyePoint Pharmaceuticals maintains a strong cash position of $371 million, expected to last until 2027.
• DuraView’s Phase 3 trials for wet AMD are progressing rapidly, with 60% enrollment achieved.
• A new manufacturing facility in Northbridge, Massachusetts, is set to produce over one million inserts annually.
• The company’s market strategy includes using DuraView in combination with existing VEGF inhibitors.
• CEO Jay Duker emphasized DuraView’s multibillion-dollar potential upon approval.

Financial Results

• EyePoint reported $371 million in cash and cash equivalents at the end of last year.
• This financial reserve is projected to support operations into 2027, beyond the wet AMD data readout expected in 2026.
• The company does not plan to access equity markets this year.

Operational Updates

• The Phase 3 trials for DuraView in wet AMD, named Lugano and Lucia, are ongoing, with full enrollment anticipated by the second half of this year.
• A new FDA and EMA-compliant manufacturing facility in Northbridge, Massachusetts, aims to produce over a million inserts per year.
• Current trial batches are produced in Watertown, Massachusetts, with future batches planned for the Northbridge facility.
• The company is focusing on wet AMD, with DME pivotal trials slated for 2026.

Future Outlook

• EyePoint anticipates top-line data from the Phase 3 wet AMD trials in 2026.
• The company aims for an every-six-month dosing label for DuraView.
• Plans are in place for DME trials to demonstrate non-inferiority to Eylea, with results expected in 2026.
• Market strategy includes targeting both naive and previously treated patients, with an expected market penetration of 25 to 45%.

Q&A Highlights

• Key opinion leaders suggest high usage of TKIs like DuraView, potentially in 80% of their patients.
• Duker outlined three treatment strategies: switching to DuraView, combining with ligand blockers, and alternating schedules.
• Addressing stock price concerns, Duker emphasized DuraView’s potential as a multibillion-dollar asset upon approval.

For a detailed understanding, readers are invited to refer to the full transcript below.

Full transcript - Leerink’s Global Healthcare Conference 2025:

Jay Duker, CEO, EyePoint Pharmaceuticals: mutations. That’s just not going to happen. So there’s a couple of companies trying to work on gene agnostic ones

Unidentified speaker: that might cover multiple, but they’re not there yet. Yes. Okay. Let’s do it. Yes.

Oh, I’m sorry.

Jay Duker, CEO, EyePoint Pharmaceuticals: We actually

Unidentified speaker: EyePoint Pharmaceuticals, Jay Tuker, the CEO. Thank you very much for joining us.

Jay Duker, CEO, EyePoint Pharmaceuticals: My pleasure.

Unidentified speaker: Looking forward to seeing the presentation, and I’ll let you take it away.

Jay Duker, CEO, EyePoint Pharmaceuticals: Thank you very much. Thanks, everybody, for coming in late in the day. So yes, I’m Jay Duker, the CEO of EyePoint. And the next slide, if it were to come up, would tell you that we are a publicly traded company and we have a long list of disclosures, which I flipped right over. So feel free to go to our website if you are interested in those.

So EyePoint is the leader in sustained release drug delivery for retinal diseases. Our lead asset is called DuraView. It is the small molecule tyrosine kinase inhibitor called virolinib, which is best in class and patent protected. It is in our DuraSert eDelivery platform, which gives us the sustained release technology. The DuraSert sustained release technology has been in four FDA approved products.

It’s been in tens of thousands of patients, and there’s a very good safety profile across all those indications. We’ve done four studies with DuraView, including a large 160 person wet AMD Phase two. That DAVIO two data has been enabling us to do very rapid enrollment in our global Phase three pivotal trials, which we’re in the midst of right now and which I will update you on today. We also recently reported highly positive Phase two data for DuraView and diabetic macular edema. We have a strong balance sheet with $371,000,000 in cash and cash equivalents as of the end of last year.

And that takes us into 2027 well past data for wet AMD in 2026. So our two programs for Derview wet AMD and diabetic macular edema represent significant market opportunities given that these two indications are eighty percent of the global VEGF mediated disease market. And this is our pipeline DuraView again in wet AMD well into Phase three. DuraView for DME, which positive phase two data, which I will review. We also have EYP two thousand three hundred and one, which is the small molecule rasoprotofib, which we’ve been able to put into DuraSert E and make it last six months.

This is a tie to agonist. By agonizing tie to you up regulate angiopoietin one, you down regulate angiopoietin two and that stabilizes retinal vasculature. Once again, DuraView, formerly called EYP nineteen oh one is virolinib and Duracered E. The E stands for erodible or not all that imaginative. And again, virolinib, small molecule tyrosine kinase inhibitor acts at the receptor level.

So this is a new mechanism of action for VEGF mediated diseases. VEGF blocks all of the VEGF receptors, which means it blocks all isoforms of VEGF, including VEGF, C and D. In addition, it blocks PDGF, which theoretically should give an anti fibrotic effect. And in the long term, the three causes of visual loss and wet AMD are under treatment, geographic atrophy and fibrosis. And we hope to take care of two of those.

At the doses we’re using in humans, we do not block tie two. I mentioned tie two already. You want to agonize it. You don’t want to antagonize it. If you block it, you will up regulate angiopoietin two, which destabilizes retinal vasculature.

Duraceart features no delay in onset. We have certainly evidence in animals that we get immediate bioavailability within hours. And now we have some pretty compelling DME data showing that the benefit comes as early as four weeks. We feature zero order kinetics, which means after a short initial burst of drug from the surface of the insert, it within weeks goes to a steady state and stays at that steady state release every day, every week, every month until the inserts are nearly depleted of drug. That allows what’s been referred to as micro dosing, which means relatively small amounts of drug in these inserts can give excellent efficacy results over long periods of time.

Our inserts are designed so that the drug elutes before the matrix completely goes away. That’s deliberate. You don’t want free floating drug in the eye. You want to be able to control drug release till the end using your matrix. But the version of DuraView that we used in the DMD trials that we’re using in the phase three wet AMD trials, and we will go to market is 94% drug, only 6% matrix.

That matrix should go away within months after the drug is completely eluded. And this is an interesting and we think actually for retina specialists may be very helpful, but you don’t need to cold storage our drug. You can it’s shipped and stored in ambient temperature. Retina specialists have refrigerators, obviously in their offices where they keep all these biologics. And now that there are so many to choose from, the refrigerator is getting pretty crowded.

They won’t have to make room for us. They can put it on a shelf. These are the four studies that we’ve completed. Davio, which was a Phase one wet AMD trial, Davio two, the Phase two wet AMD trial, PAVIA and NPDR trial and Verona, the diabetic macular edema trial. We’ve treated over one hundred and ninety patients with at least year follow-up in all of them.

And we’ve had no ocular or systemic SAEs reported due to our drug or drew the inserts. The safety profile looks very good. Besides this safety profile, you may be aware that vironolinib, when it was formally called x eighty two, was studied in wet AMD as an oral drug. It went through phase two with really pretty good efficacy, but it didn’t get past phase two because systemic toxicity. There was no ocular toxicity reported.

So we have a database of another approximately 150 patients and wet AMD from oral overall and it with no safety issues. You can see the efficacy outcomes on on the right and in all the studies we did show efficacy. So let’s go into the phase three pivotal trials that are ongoing. They are called Lugano and Lucia. They are two identical global trials with the primary endpoints the same non inferior change in visual acuity from day one to combined fifty to fifty six weeks compared to an Eylea control.

In order to inform the structure of the Phase three, we use the Phase two trial. And again, how we came up with a phase two, we originally were contemplating going directly to phase three after the phase one. In 2022, we had a type C meeting with the FDA and agreed on a phase three protocol. We then elected not to go directly to phase three for good reason, because we learned a lot from the phase two, but we used that outline of the protocol to design the phase two and hence the current phase three program. This summarizes the phase two data.

We had two doses of our drug, two milligrams and three milligrams against an Eylea on label control. These were all previously treated wet AMD patients. They all received a load of Eylea. That’s a monthly injection on day one, week four and week eight. And then our drug was dosed once.

And you can see the primary endpoint at eight months, six months after our drug went in was there was essentially no difference in visual acuity in both doses of our drug against the Eylea control. The p value for difference was 0.0009. So essentially identical. Again, I mentioned safety already. I’ll probably mention it two more times because it’s so important in the retina community.

There were no safety issues that developed in this trial. Secondary endpoints, significant reduction in treatment burden, 80% or more depending on how you measure it. Supplement free, two thirds of the eyes went up to six months with no supplement. And we had very good anatomic control. OCT, again, about 300 microns is the normal thickness on OCT of the macula.

And the standard deviation is 10 microns of the test. So you can see we were below standard deviation difference. So this is the outline of the two pivotal trials. Once again, very similar to what we ran in the Phase two with a couple differences. First of all, we are repeating our drug every six months.

We are going for an every six month label. The primary endpoint is a blended visual acuity change at week fifty two, week fifty six. That blended endpoint is what’s desired by the FDA, and we think it’s a good thing also. We’re going against EYLEA two milligrams on label. So after the load, every other month, Eylea.

We are able to submit the NDA after that fifty two, fifty six week endpoint, but the study will be carried into the second year for safety. And again, there’s no non inferiority margin for the second year. We certainly will measure efficacy, but the primary efficacy endpoint is at approximately one year. We’re enrolling about approximately seventy five percent of the eyes will be treatment naive when they would go into the study, about twenty five percent in each study will be treatment experienced. We expect full enrollment for both of these trials in the second half of this year, which means to read out for the data, top line will be a 2026 event.

We have been able to execute really, really well. And this gives you a timeline for how we’ve been able to advance to review on wet AMD so rapidly. We announced February, just about two weeks ago, that the first trial Lugano was 50% enrolled. And I can tell you with a little asterisk down at the bottom there, as of last night, we were 60% enrolled. So you can do the math, took about two point five weeks to go from 50% to 60%.

We are still guiding that full enrollment will be in the second half, but obviously, we may well do better than that. But top line data is thirteen to fourteen months after last patient in. That’s the way you can do the calculation. We’re really proud of the manufacturing facility that we built. It was very obvious to us, when we started this program four years ago that our Watertown, Massachusetts office didn’t have the capability to make these inserts at scale.

And therefore, we needed an alternative. We actually searched across The United States, multiple states, over 70 sites were considered and we ended up about forty five minutes west of Watertown in a very small part of Central Massachusetts called Northbridge. We built this ground up to our specifications, eight large clean rooms. It is in the process of doing early registration batches, and we fully expect it to be fully FDA and EMA compliant. All of the current batches for the Phase III wet AMD trial have been made in Watertown.

Everything after that will be made now at the Northbridge facility. And we are preparing for commercial success in the sense that this facility should be able to supply both United States and global with the review. We’ll be able to make over a million inserts a year here. So on to diabetic macular edema. DME, again, a very large potential market for us, very large unmet need.

Diabetics tend to be younger than wet AMD patients. They tend to need more intense treatment, especially in the first year or two. And because they’re often working age and have multiple doctors, they tend to not come in for visits. So missed visits and lost to follow-up are really important here. So looking at the numbers, in another five years, it’s estimated we’re going to have over fifty million diabetics in The United States, a quarter of them developed DME.

It’ll be a $4,000,000,000 global market by then. And missed visits matter. About half of the patients have the later missed visits and there’s data that suggests even one missed visit can result in permanent loss of vision. So here’s what we’re trying to accomplish with DuraView. The top four lines are four of the current FDA approved products that are being used.

You’ve got Eylea and high dose Eylea, and you can see the frequency on label of each of those drugs. You’ve got Lucentis monthly and then you’ve got Vibezmo and then you can see under maintenance what we hope to accomplish every six months. So if we can show similar or if you look at the DME results, we may even be slightly superior to EYLEA within every six month dosing. We think we will capture a lot of the market. So the VIRONA trial was designed as an open label of Flibercept control for active patients with DME.

So active means they had decreased vision and they had fluid. This is the first trial that we ran where everybody was active. When we did the wet AMD trials, patients could be active or they could be dry. We didn’t make a distinction. They had to be active here.

So all the patients were previously treated. They all had fluid, and they were randomized to three different groups. Our high dose of two point seven milligrams, which represents two inserts of these higher payloads that we use using in the wet empty wet phase threes, two point seven high dose one point three milligram or one insert low dose or enaflibrocep control. This is what I would refer to as a PRN study. What that means is after the initial treatment on day one, which consisted of Eylea and everybody, and then thirty minutes later, their dose of DIRIVEW or a sham.

There was no further treatment for the eyes in this trial that was mandated unless they met supplemental criteria. The primary endpoint for this study again was not visual acuity. It was time to first rescue. We were attempting to show longevity in this trial and we certainly accomplished that. But the secondary endpoint was change in visual acuity.

So rescue criteria, all of these trials, as you may know, the sustained release trials all have what’s called rescue or supplement criteria. And I’d like to say from the outset, if you talk to my colleagues, they’ll say, oh, I don’t use those in the real world. And it’s true. We don’t use supplement criteria when we have a patient in front of us. There’s a lot of factors that go in why we would retreat a patient.

But in these trials, you need to have it. And I think we’ll also make the obvious statement that the FDA doesn’t seem to mandate one set of supplement criteria over another. Each company does it a little bit differently. We use the same supplement criteria in this phase two DME study as we did in the phase two wet AMD study. And those are the first four criteria you can see up there.

We also added a fifth criteria for just this study. Remember, all these eyes were active. And we didn’t think that it would be right to watch a patient with active disease for six months without therapy if they weren’t better. So we put this fifth criteria in, which is by month three, if they hadn’t improved 10% on their anatomy, then they were going to get supplemented. And this is not a supplement criteria that anyone else had ever used.

It was also not a supplement criteria we’re going to use in the Phase three, but it actually accounted for eighty percent of the supplements in this trial. So without this criteria, there probably would have been fewer supplements. Nevertheless, we hit the primary endpoint. Not only did we have more maintenance than Eylea, but we had improvement in the vision and improvement in the anatomy. The improvement was about seven letters at the end of the study in the anatomy on central subfield thickness was about 78, 70 six microns.

Also listing the safety issues that did not happen. I think these are the concerns that some people have. We didn’t have any impaired vision to our inserts, no endophthalmitis. I always like to add, look, we’re doing an injection, someday we’re going to get a case. So far, we haven’t had any.

Retinal vasculitis, don’t expect to see any of that because we’re not a biologic, and no insert migration. This is a graph of the primary endpoint. And you can see at week twenty four, we were superior to the control. Our high dose is the blue line, our low dose is the magenta line, and the Eylea control is the green. One other note is ICE could have been supplemented as early as week four, but nobody was.

The first supplements in all three groups were given at week twelve. So if you look at the week twelve results, that’s purely our drug versus purely one dose of Eylea, if you want to look at head to head. Now the other thing I like to point out here is the supplement up to week twenty four. Now why is that important? This is the way most of these studies are reported up to the time that you would have in a larger trial or pivotal trial repeated your dose.

So remember, we’re a six month trial in a six month interval. So that in the pivotal trial, we’ll be repeating our dose at week twenty four. And therefore, you can’t be supplemented if you got a mandated injection. So if you’re trying to go head to head against if you say, well, how well would you do against VOBISMO? That’s the number you wanna look at with the week twenty number, not the week twenty four number, the up to and obviously seventy three percent made it supplement free up to week twenty four.

So how about Visual Acuity? So here’s the graphs. Again, blue is the high dose, magenta the low dose, green is the control. That’s purely our drug against the single injection of EYLEA up to week twelve. And you can see there’s a considerable improvement in the blue line and it comes early at week four.

So there’s substantial improvement in the vision within four weeks showing again that we have immediate bioavailability and we were numerically and anatomically superior to Eylea at week four. That’s again an important endpoint. And as you get to the end of the study, it’s true that at the end of the study, all three arms ended the same about seven letter improvement, which we think is great because most likely we will do a non inferiority trial against Eylea. And doesn’t mean we have to be better than Eylea, we just have to tie them. And actually, we don’t even have to tie them.

We can be slightly worse because I like to remind people that the high dose Eylea was one point four letters worse than two milligram Eylea, but it was non inferior. Also, just to put this in perspective, if you look at Vivid and Vista, which were the two trials that got Eylea approved, there was about an eight letter improvement. If we improve seven and they improve eight, we’re going to be non inferior. So very comfortable with this. But buried in this data is one outlier.

Notice the blue line at week twenty takes a big dip between twenty and twenty four. That’s a single patient caused that. And that patient came in late. The week twenty four visit should have been that the week twenty visit, but they were outside the window, so counted as week twenty four. Had they come in at week twenty, that would have been frame shifted to the left.

But I wanna show you what’s that?

Unidentified speaker: It would have been 10.

Jay Duker, CEO, EyePoint Pharmaceuticals: It would have been. There it is. Exactly right. This is without that single patient. The the rest of the 10 eyes improved 10 letters.

Now is that fair to do that? I might tell you it’s fair to do it, but this is the facts. And that in a larger trial, if you have an out outliers, they’re gonna be randomized to both arms. This again is the OCT data, immediate drying effect in both doses visible at week four. And unlike the visual acuity, which ended up the same, the drying effect in both our drugs doses was much better than Eylea.

And if you talk to the retina specialists, this is what they really look at. Visual acuity can be slow to improve in this disease. Not only that, sometimes you can’t improve the vision because there’s damage to the retina. But the anatomy doesn’t lie. It’s quantitative and you can see our drug dried the retina better at the end.

Did a subgroup analysis where we just looked at the eyes that didn’t get a supplement. The reason this is important is you could criticize a supplement trial like this and say, well, if you set your supplement criteria too high, too lax, you’ll have eyes that in the real world would have been retreated because they were getting worse. But in your study, they didn’t get retreated because they didn’t meet the criteria. This shows you that the eyes that didn’t get supplemented didn’t need to get supplemented. They improved to 10 letters by week eight, and they stated 10 letters for the rest of the study.

So when this drug works, it worked really well in these eyes. These eyes were really stable. OCT, same story. You do see a dose response here, but the OCT has improved 117 microns. So these eyes started at about four twenty microns, 174 four twenty minuteus 117 around 300 microns, which is almost normal thickness.

And this next slide reflects that. If you ask the question in the unsupplemented eyes, how many finished the study with no DME? About half of the DuraView eyes had no DME at the end of the trial. None of the control group had no DME, which also tells you that the control group is probably undertreated in this study. I would agree.

But even had they been treated more in this trial, I don’t think they would have done better than 10 letters. Couple of cases. I don’t know if you can see this at the top here, but this eye had two IV lasers in a VABYSMO going into the trial. The VABYSMO was about six months before the screening, which is up top left. For those of you who’ve never seen a OCT before, this top right there, that’s a normal OCT.

There’s a dip in the middle. That’s the center of the MAC is supposed to be there. Anyway, that you can see the fluid, you can see the vision. And then in the week or two between screening and day one, you can see the Vibisum is really wearing off because there’s even more fluid and worse vision. Then look what happens.

Eylea and our drug given at day one, at week four, dry. And look at the visual improvement, almost 20 letters. And it’s sustained. Now you might say, well, Jay, look at month six. There’s a little bit of fluid there in the temporal side.

Yeah, it’s coming back, didn’t meet criteria. I think most of my colleagues wouldn’t retreat that. But that’s six months after our drug. Look at six months after FABISMO. We did much better than VABISMO in this patient.

Here’s another example. This patient was getting monthly VABISMO. They’re getting monthly because they still have fluid. Two months after the last VABISMO, seventy two letters, that’s okay, vision, moderate visual drop. They’ve got fluid.

And once again, look at what happens between screening and day one. The Vabismote effect is going away. They got even more fluid and worse vision. So day one, they get the two drugs. Month one, it’s better, but not dry.

Month four, even better, not dry. By month six, completely dry. What does that also tell you? First of all, look at our drug six months later compared to three months after the VOBISMO. We did much better in the side than VOBISMO did.

The second thing it tells you is this effect, that’s all our drug. The Eylea is out of the eye in weeks. So you could argue that the month one result is assisted by Eylea, and I wouldn’t argue with that, but not the month six. It doesn’t last that long. So again, safety, no Dervu related ocular systemic SAEs were doing really well from a safety perspective.

And we talked a little bit about this, so I won’t go into more detail. Just to then clinical trial summary met the primary endpoint, immediate clinically meaningful decrease in fluid and increase in vision, significant reduction in treatment burden and the results were really driven by our drug. So we have been a real execution story. I do like to brag that we dosed the first patient with DuraView and wet AMD in January of twenty twenty one. And we are here now in a little after January 2025 halfway through a pivotal trial in this in this drug.

So we expect to continue with the execution that we have done. We’re well funded to do that. And we are now fully concentrated on wet AMD. We’ve made this announcement last week. And just to reiterate here, we have no intention of tapping the equity markets this year.

DME Pivotal will be a 2026 event for us. We’re going to fully prepare for them, but not execute until 2026 because we want to make sure that we have the cash runway after the wet AMD readout. So thank you very much and happy to answer any questions anyone might have. Let’s

Unidentified speaker: talk about what are the key debates? What are the key questions you get that seems to be

Jay Duker, CEO, EyePoint Pharmaceuticals: Why is your

Unidentified speaker: stock so low? Well, leave that alone.

Jay Duker, CEO, EyePoint Pharmaceuticals: I mean, that’s that’s it. You’re really I got to say, I don’t think anybody would deny that we have a potential multibillion dollar asset here and that if we’re approved that doctors will use us. Last week at the Cowen meeting, there were two KOLs who both said that they would use TKIs at eighty percent of their patients. So our data suggests twenty five percent to forty five percent penetration.

Unidentified speaker: Can we talk about how they use it? Like in the real Yeah.

Jay Duker, CEO, EyePoint Pharmaceuticals: Run-in the background on everybody. Just about everybody. Because if that way, if you get a patient out six months and you want to, you can. But remember, one of the things is that we are a different MOA and it’s not an either or. You can’t model us as we’re going to take away market share from them.

We will probably to a degree, but people can still use the lichen blockers together with us. Go back to the DME data. The DME data is explainable in two ways. Either our drug works faster and better than Eylea because our drug may be a better DME drug or it worked in combination with Eylea faster and better. Doesn’t matter to me.

Either way, we win. And so that the idea that doctors may choose to use our drug every six months and sometimes see patients sooner and use a Ligand blocker in between, they may. To win, we always make sense that they might do that.

Unidentified speaker: Do you think this is used in year one, like right out of the gate? Do you think it’s used after six months, like people get their loading dose and then a few doses of Eylea and then

Jay Duker, CEO, EyePoint Pharmaceuticals: let’s switch over? I think I think it’ll be a couple different ways. I think you’ll have the early adopters take their patients who can’t get longer than, let’s say, eight weeks intervals and switch them over and see how they do. And they can do it either as a PRN, meaning they’ll watch them carefully to see six months or you could do a treat and extend, meaning you treat with both drugs and then you see them back at a longer interval, treat with a ligand blocker, see them back at a longer interval and keep going until you see how long you can go. I think the third way is something that I talked about already is that people may put on a schedule.

Just say, I don’t want to do the treatment extent. I don’t want to worry about it. I’m going to put everybody on an every three or four months schedule alternating drugs. And that’s going to actually probably control well over ninety percent of the way in the population doing that, a priori without thought. Just put them on a schedule.

Unidentified speaker: Just every four months they get Yeah,

Jay Duker, CEO, EyePoint Pharmaceuticals: every three or four months and alternate. And that as we look at our phase two data, that suggests over ninety percent of what anti patients will be under good control that way. You’ll get the advantage to MOAs, you’ll get anti fibrosis, you’ll also get what what I like to call the insurance policy, which is you’ve got a sustained release insert in there that if that patient gets sick or misses a visit, you don’t have to worry as much that they’re going to really head south because of under treatment.

Unidentified speaker: Yeah. Interesting. Anybody got any questions? Thank you.

Jay Duker, CEO, EyePoint Pharmaceuticals: Thank you. Appreciate your attention.

Unidentified speaker: It’s great.

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