EyePoint at Goldman Sachs Healthcare Conference: Sustained-Release Vision

On Tuesday, 10 June 2025, EyePoint Pharmaceuticals (NASDAQ:EYPT) presented at the Goldman Sachs 46th Annual Global Healthcare Conference. The company spotlighted its strategic advancements in sustained-release treatments for retinal diseases, revealing promising trial data and operational strides. While EyePoint’s cash reserves provide a robust runway, challenges remain in achieving full trial enrollment and navigating regulatory approvals.

Key Takeaways

• EyePoint is advancing Phase III trials for Duravu in wet AMD, with the Lugano trial fully enrolled.
• Positive Phase II results for Duravu in diabetic macular edema show improved efficacy and safety.
• EyePoint’s cash position of $318 million supports operations into 2027.
• A new manufacturing facility in Northbridge, MA, is now operational, enhancing production capacity.
• The company plans to submit a New Drug Application (NDA) by 2026.

Financial Results

• Cash Position: EyePoint reported $318 million in cash at the end of Q1 2025.
• Cash Runway: This financial cushion extends operational capabilities into 2027, beyond the anticipated Phase III trial data readout.

Operational Updates

• Lugano Trial Enrollment: The Lugano Phase III trial in wet AMD is fully enrolled with over 400 patients.
• LUCIA Trial Enrollment: The LUCIA trial is 60% enrolled and is expected to reach full enrollment in Q3 2025.
• Manufacturing Facility: EyePoint’s new facility in Northbridge, MA, meets U.S. FDA and EMA standards, with a capacity of over one million inserts annually.

Future Outlook

• NDA Submission: EyePoint aims to submit an NDA by the end of the two-year trial period.
• Lugano and LUCIA Data: Top-line data for the Lugano trial is expected in mid-2026, followed by LUCIA data several months later.
• DME Pivotal Trial: Plans to initiate pivotal trials for DME in 2026.

Q&A Highlights

• The conference call did not include a specific Q&A session.

In conclusion, EyePoint Pharmaceuticals is progressing in its mission to innovate retinal disease treatments. For more details, please refer to the full conference call transcript.

Full transcript - Goldman Sachs 46th Annual Global Healthcare Conference:

Jay Duker, President and CEO, EyePoint: Good afternoon. Thanks for listening. My name is Jay Duker. I’m the president and CEO of EyePoint. I’d like to thank Goldman Sachs for inviting us to present today.

And we are a publicly traded company, and I will be giving some forward looking statements. If you’d like our full legal disclaimers, I invite you to go to our website. EyePoint is the leader in sustained release drug delivery for retinal diseases. Our lead asset is called Duravu, which consists of vorolanib, a small molecule tyrosine kinase receptor inhibitor, which is best in class. It’s patent protected.

It’s in our patented DuraSert E sustained delivery technology, which makes the inserts fully bioerodible. We are currently in two pivotal phase three trials in wet age related macular degeneration. The trial is called the Lugano trial, and we announced several weeks ago that the trial is now fully enrolled with over 400 patients randomized. The trial is called the LUCIA trial. We announced it’s sixty percent enrolled as of several weeks ago, and we’ve updated our guidance to have full enrollment in the LUCHIA trial in the third quarter of this year.

In addition, we’re the only TKI program to be in diabetic macular edema, or DME. We had highly positive efficacy and safety data from our Phase II VORONA trial in DME. And in fact, we’ve had favorable safety profile across multiple indications with over one hundred and ninety patients treated with Dereviu to date. Our cash looks great. We currently have $318,000,000 at the end of the first quarter, which gives us a runway into 2027 approximately a year post data from the Phase III trials.

This is our pipeline. And, again, we are in phase three and two wet AMD trials, Lugano fully enrolled, Lucia by 3Q. We have positive phase two DME data, and we will be updating our DME plan later in the year for pivotal trial. And in addition, we have EYP2301, which is the small molecule called razeprotofib that we’ve been able to put into sustained release. This is a TIE II agonist, and we will be advancing it for serious retinal diseases.

We have some pretty good treatments for wet age related macular degeneration. They’re safe and effective, but they all lack one thing, which is durability. And there’s significant evidence that we need more durability in wet AMD. Many patients are chronically undertreated, and in the long term, many patients lose vision because they are undertreated. The short acting current anti VEGFs put a great burden on patients, on practitioners, on families, and on society, and missed visits can result in permanent visual loss.

There’s evidence that even one missed visit in scheduled therapy could result in significant visual loss. The fact that we have an aging population with increased lifespan only means there’s gonna be more and more patients who get with age related macular degeneration and require long term therapy. Diabetic macular edema is another area for which we have good treatments, anti VEGFs, that are safe and effective. Durability is needed. Diabetic macular edema typically affects working age people who have multiple concurrent clinical problems, have to go to multiple doctor visits, and the significant burden of intravitreal injections, especially in the year, means that patients can be very noncompliant in this disease.

DME is prevalent. About a quarter of the patients will develop it. Currently, the market is about $3,000,000,000. And, again, up to fifty one percent have delayed or missed visits resulting in significant visual loss. So our solution, is DuraVu.

DuraVu, again, is a small molecule tyrosine kinase inhibitor that is in our patented delivery system that we call DuraSert E, E for erodible. The DuraSert delivery system has already been in four FDA approved products and in non erodible form. DuraSert E is each insert is tiny. It’s about one five thousandths of the vitreous cavity. And it’s delivered in the retina specialist’s office with a standard intravitreal injection.

Dursor E provides continuous dosing, what we refer to as zero order kinetics. Zero order kinetics means after initial burst of the drug, you get a steady state release for the lifetime of the insert. In humans, we believe the inserts will last a minimum of six months in all patients, and the majority of patients should have the drug depleted by month nine. These are solid injectable inserts. They’re in a bioerodible matrix, and they are designed to drug fully before the matrix goes away.

What you don’t want is your matrix to go away before the drug is fully eluted because you will then have free drug particles in the eye, which can be a problem. We have favorable safety profile across multiple indications, and again, this is a fully erodible matrix. Varolanib is a small molecule tyrosine kinase inhibitor, selectively inhibits all VEGF signaling because it inhibits all VEGF receptors. In addition, it inhibits PDGF, which should lead to an inhibition of fibrosis. In the long term, there are three reasons why wet AMD patients lose vision.

The is noncompliance. The is fibrosis. And our drug should tackle both of those problems. Durasert E, again, one five thousandths of the vitreous cavity for each insert. But our scientists have been able to manufacture this in a way that it is now 94% drug, only 6% matrix.

We have shown in animals and now in humans looking at our diabetic macular edema data that we have no delay in the onset of our drug release. In animals, we’ve shown, the drug release reaches the cord within hours and within a day is at therapeutic levels. The zero order kinetics results in no fluctuations, which should mean no fluctuations in control of the fluid, which is important for long term visual acuity. We have no free floating drug particles in the eye. And interestingly, we don’t need cold storage.

We can be shipped and stored at room temperature, which is a real advantage when you think about how big the freezers that retina specialists have to have with all the current FDA approved products. Also, very important, we have no PEG. PEG has been implicated as the cause of potential vasculitis in sensitive patients, and we know we don’t have any PLGA. PLGA releases into an acidic environment and has the potential to cause corneal toxicity. We’ve completed four studies so far, the Davio phase one wet AMD trial, the Davio two phase two wet AMD trial, Pavia NPDR trial, and Varona phase two DME trial, a total of a hundred ninety one patients treated with our drug with no safety concerns.

We’ve had no duraVu related ocular or systemic SAEs reported to date. There has been good to excellent efficacy shown through these four trials. I’m now going to talk a little bit about our exciting wet AMD program, the Lugano and Lucia trials. These trials are designed as a non inferiority primary endpoint. This is an established approval FDA pathway.

The last four wet AMD approvals have been with a non inferiority design. We had a noninferiority robust phase two trial, which showed excellent results, and our phase three program was modeled after that. We’ve had proactive FDA interaction both at a Type C meeting in 2022 about our pivotal program and, again, at an end of phase two meeting in April 2024 with agreement with the FDA on the trial design and written alignment on our masking and our non inferiority margin of minus 4.5 letters. This is also what we’d refer to as a real trial design. Doctors are used to the on label two milligram EYLEA control arm.

They know how it’s going to behave, and a drug against it will they will know how to use this in the real world. To review the W2 phase two wet AMD results, we had two doses of our drug, two milligrams and three milligrams versus an on label EYLEA two milligram control, and there was essentially no change in visual acuity at the primary endpoint. The two milligram arm was minus 0.3 letters worse than EYLEA. The three milligram arm was minus 0.4 letters worse. When you did this as a p value, the p value for these being identical, to control was 0.0009.

So we had essentially the same control of vision that on label EYLEA had. I’ve emphasized safety already, but the reduction in treatment burden was about 80% depending on how you measured it. Reduction in treatment burden can refer to a retrospective look back on how many injections did these patients receive leading into the trial. And we had about a 90% reduction in treatment burden looking at it this way versus how many shots within the trial did the patients get after the load, and we had about an 80% reduction looking at it that way. And this was a tough to treat group in our phase two.

They were previously treated patients who on average had about 10 injections a year normalized leading into the trial. In The United States, on average, patients receive about six injections a year, so this truly was a needy VEGF mediated disease patient population. Two thirds of the eyes made it about six months after our drug was inserted without any supplement, and about fifty percent made it a full year. We had excellent anatomic control. Anatomy is measured on optical coherence tomography or OCT with a normal foveal thickness of about 300 microns.

Anything about three twenty five is considered to be abnormally thick. You can see from this slide that the anatomic control was less than one standard deviation of the test. So this went on to inform our phase three trial design, which you can see on this slide. The phase three trial design consists of two arms: Duravu two point seven milligrams, which is our higher payload insert with 94% drug payload against on label aflibercept control. All patients get randomized on day one.

They receive aflibercept at day one, week four, week eight. Thirty minutes later, then they either receive their dose of DuraVu or they receive a sham. Patients come in monthly and are evaluated monthly. Every other month, the the DuraVu arm gets a sham. The aflibercept arm gets another aflibercept.

And then at week thirty two, a injection of DuraVu is given. We are hoping for a label of every six months. This is a two year trial, but we expect to submit the NDA at the end of one year. Again, the primary endpoint is non inferiority change in visual acuity between the Duravu arm and the control arm with a blend of week 52 and week 56. Lugano was fully enrolled.

Lucia should be fully enrolled in 3Q of this year. A couple of announcements to make about this as well. We’re really proud to to announce that the EMA has approved our protocol. So we now have approval of the two largest regulatory agencies in the world. Some of you may be aware that the EMA barrier to approval for clinical trials is somewhat higher than the FDA, and that also leads us to be optimistic that should our trials prove to be positive, that we could get approval in Europe.

We have now the European site in The Czech Republic up and running and have now enrolled the OUS patients in the LUCIA trial. This is a timeline for the trials. And again, starting in January of this year, and you can see how rapidly we were able to enroll Lugano. Again, we enrolled over 400 patients in about seven months. It is, we believe, the fastest enrolling wet AMD trial recorded to date.

Lucia is started several months behind, but is enrolling at approximately the same rate. We then expect top line Lugano data in mid-twenty twenty six, top line Lucia data several months later, but they are identical trials. And if we are had a positive top line in safety at Lugano, we have every reason to believe Lucia will have a similar result. I’d now like to talk a little bit about diabetic macular edema. DME is also a prevalent problem worldwide.

We did a phase two VORONA trial in DME. The, attempt here, of course, is to reduce the treatment and visit burden in diabetics without harming the visual acuity outcome. And you can see from this slide, with the four approved products, how often the patients would need to come in for injections, and at the bottom what we hope to accomplish with DERVIEW with every six month dosing. The VORONA trial enrolled only active DME patients. They had to have decreased vision, and they had to have significant fluid to be enrolled in the trial.

So this is the trial which we enrolled patients at a hundred percent had wet maculus. On day one, the patients received aflibercept, and then thirty minutes later they either received one point three milligrams of Duravu or two point seven milligrams of Duravu, or they received a sham. The primary outcome of this study was not visual acuity. The primary outcome was time to rescue. And so there were no other mandated injections in this trial after day one, but the patients came in monthly, and they could be subjected to supplemental injections if they met supplemental criteria.

This is the top line result of the VORONA trial. The high dose, the two point seven milligram dose, which is the dose we’re using in the phase three and our presumed go to market dose, showed that the primary endpoint was achieved, extended time to supplement versus the aflibercept control. We had early improvement in both best corrected visual acuity and anatomy measured by central subfield thickness on OCT with the improvement of seven letters at the end of the trial and minus 76 microns drier in CST. And, again, safety looked very good. No SAEs reported due to the drug.

This is the curve of visual acuity. And I’m only showing the part of the curve here because no patients received the supplement before week twelve. So this is directly head to head EYLEA versus Duravu, and you can see at week twelve, the blue line, which is the high dose Duravu two point seven milligrams, was significantly better than EYLEA. But I also like to point out week four. Week four is directly head to head to review against a single EYLEA in a wet population and look at the improvement in visual acuity and drying that occurred as early as week four.

And this was sustained for most patients throughout the study. So if you’re a patient and you have a decreased vision and a wet macular due to DME, would you rather get better in four weeks? Would you rather get better in six months? I think most of us would pick four weeks. So this is an early and sustained effect in visual acuity through the length of the study.

At the end of the study, all three arms ended up with the same visual acuity, which is fine, because in the pivotal trial, we’re gonna likely do a non inferiority. We don’t have to be better than EYLEA. We just can’t be significantly worse. Within this trial, however, there was a single outlier. And if you go back and look at the blue line again and look between week twenty and week twenty four, notice how the visual acuity drops.

That drop was a single patient who lost 20 letters, and they were late coming in. That week twenty four visit should have been a week twenty visit. And by the way, they did get supplemented to week twenty four, and their vision came back. But if you take that patient out of the equation and just look at the rest of the patients in the high dose, the high dose gained 10 letters, significantly better than EYLEA. And this is the anatomy.

And once again, what’s powerful about this is the anatomy and the acuity, the structure and the function match perfectly. The visual acuity improved in four weeks, and the anatomy improved in four weeks. That tells you it’s real. And this is again what retina specialists look for. They look for the improvement in anatomy because we know that the visual acuity can lag sometimes in this disease, when treating with anti VEGFs.

It can take many months for the vision to improve, but with a high dose, we had early and sustained improvement in both the vision and the anatomy. And that continued in the high dose and in the low dose as well throughout the study, with 75 micron improvement versus only a 43 micron improvement in the Eylea arm. We then went on to do a subgroup analysis and said let’s just look at the eyes that were unsupplemented. They purely got our drug or they purely got a shot of Eylea. Let’s see how they did.

The top is the visual acuity, and again the blue line is two point seven milligrams to review only after that single shot with EYLEA day one. Notice that the improvement in vision is seven letters at week four and about 10 letters at week eight. A very fast vision improvement, and it’s sustained. The line is flat through the rest of the trial. What this tells you is when this drug works in DME alone, it works really well.

These patients weren’t gaining fluid or losing vision at the end of the trial. And again, look, the graph at the bottom is the CST. Early improvement of 120 microns. Now these eyes started at four twenty microns. Four twenty minuteus 120 is 300 microns on average.

They were normal within a month after injection. And it was sustained throughout the study. So again, these are about seventy percent of the patients were rescue free in the high dose, and the results were really, really fabulous. Now I want to show a couple cases. This case is from the two point seven milligram arm, and they did not get supplemented.

This is purely with our drug. On the top left is the screening, and you can see this eye has swelling. If you’ve never seen an OCT before, these black areas in here, that’s the fluid within the retina. Best corrected visual acuity is 50 letters. That’s not great.

Twenty twenty is 85 letters. And you can see between screening and day one, the eye got worse, dropped four more letters and got more fluid. What did they have received before? They had two Eylea injections twelve months and ten months before enrollment. They had a Vovismo seven months before enrollment.

So Vovismo probably wore off by then, but you can see this is active disease. And how did they do? Well, take a look. At month one, that is a normal foveal contour, normal macula, and improved about 20 letters at month one, and stayed improved through month six. Now you could argue, well maybe that EYLEA did the job for that month one.

Well maybe, except that the EYLEA would have worn off by month six. So that shows that immediate improvement in good longevity of our drug in this DME patient. The next case I think is even more impressive. If you look at the top right here, you can see this patient got Avastin nine months before enrollment, and then basically got monthly Vovismo. So if you think the retina specialist is given monthly Vobismo, why are they giving it monthly?

Because they feel like they need to. Otherwise, they would have extended the interval here. So how did they look two months out of the last Vobismo? They had a cystic fluid. They had 72 letters.

And then several weeks later after screening when they actually got enrolled, they have even more fluid. Now at month one, they had less fluid, not a lot less, still had some activity. You might say, okay, that was the Eylea effect. Maybe. But at month four, they’re almost no normal foveal contour, and look at the improvement of about 15 letters.

That’s three lines on the eye chart. And look at month six. No fluid, no normal foveal contour, 80 letters. So here is six months after our drug went in. Take a look at what they were two to three months after Vobismo.

I think you argue in this eye, our drug was better than Vobismo for DME. So the summary of VORONA is we met the primary endpoint for both doses, immediately clinically meaningful results without a full load of felbercept, just one. We got that significant improvement, and it lasted in the high dose through the length of the study. The subgroup analysis showed that the supplement free eyes were what was really driving the excellent result and continued favorable safety and tolerability. We have an end of phase two meeting scheduled with the FDA for next month.

We will update investors and analysts at the likely the end of the summer, early fall, and what the plan is for DME. But at present, we intend to start the DME pivotal trial or trials in 2026. We’re very proud of our new manufacturing facility. Our planning all along has been to grow EyePoint as a successful pharmaceutical company, not just thinking about the next clinical trial success, but long term success and long term drug development. We realized several years ago that our Watertown facility was not gonna be adequate for commercial, and we sought out a new facility.

We looked all over The United States, ended up with a site about forty five minutes west of Watertown in Central Massachusetts in a small town called Northbridge. We built a 41,000 square foot facility with eight state of the art clean rooms that opened in October. This is built to U. S. FDA and EMA standards.

We actually had the FDA involved in some of the planning, so we had their sign off on the plans. And we are in the midst of doing DuraVu registration batches to support the future NDA filing. We would expect that this facility could fully support, if successful, the commercial activity for DuraVue both in The United States and Ex U. S. We believe that we can make over a million inserts a year potentially in this center.

So this has been a really, I think, terrific story of execution by EyePoint. I do like to brag that the patient ever treated with DuraVu was treated in January of twenty twenty one. And here we are about four and a half years later, fully enrolled in one pivotal trial with another one about to fully enroll a brand new manufacturing facility and really terrific efficacy and safety data for our drug. The green check marks show you some of the things we’ve done in the last year with upcoming events, the end of Phase II meeting for DME, full enrollment for the LUCHIA trial we expect in 3Q, and top line data for Lugano mid-twenty twenty six. Thank you again for the invitation.

Appreciate you all listening. And if there are any questions, happy to answer them.

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