EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT) Q4 2023 Earnings Call Transcript

And therefore, I think if we can show in the NPDR population that we are making a biological improvement, I think they’ll be definitely read through the DME. As to the differences in the studies in the insert payloads, shouldn’t matter. Insert payloads, again, they release almost identically. They give levels that are consistent with the payload as opposed to the difference in the actual inserts. So I don’t think those particular aspects of the differences between the VERONA trial, the PAVIA trial will be of any significance at all.

Operator: Thank you. One moment for our next question. Our next question comes from Graig Suvannavejh with Mizuho Securities. Your line is open.

Graig Suvannavejh: Good morning, thank you for taking my question. I was curious in light of the data that you presented in wet AMD in the time since, have you been able to do any perhaps new market research with either clinicians or payers on their reactions? And if you have, what were the findings and if you haven’t done any, maybe you could just provide us a general big picture comment around what the feedback from the retinal specialist community has been? Thank you.

Jay Duker: Thanks, Graig. It’s a great question. And while I would say the formal aspects of both market research for both payers and practitioners is ongoing. And since it is ongoing, I really can’t comment on how the new data has changed in a quantitative formal way, what the practitioners and the payers are thinking about EYP-1901. I can say, again, in a rather qualitative way, the initial interactions we have with the payers are quite positive. And the practitioner is the same. Again, the data from DAVIO 2 was excellent. We had no — essentially no change in visual acuity over the six months after our inserts went in compared to the idea of control, and we did it with a really intact safety record and anatomic data that really went along with the visual acuity data.

So as the retina community is exposed to not only the initial data set, but the subsequent subset analysis, I think the enthusiasm amongst the potential for this is definitely growing. And in a recent conference, I think when pulled of the new agents that are available, their pulled retina specialists put EYP-1901 as the most exciting. So I think our message in our great data is getting out there, and I think it will continue to be well received in both those communities.

Operator: Thank you. One moment for our next question. Our next question comes from Colleen Kusy with Baird. Your line is open.

Colleen Kusy: Great. Thanks, good morning. Thanks for taking our questions. On the wet AMD Phase 3 design, maybe this is something that I — that you’ll get more feedback on in your FDA meeting, but can you talk about your understanding of the role of the low dose arm in the pivotal study design. Do you need to be better than the low dose? Or is that just for masking purposes? And if you do have to be better, is that statistically significantly better or just a favorable trend? Thanks.

Jay Duker: Thanks, Colleen. So in our interactions with the FDA, the second arm of our drug was viewed as a way to improve the masking in the study. There was never any indication or suggestion that the lower dose had to perform necessarily any different than the higher dose. However, as we’ve talked about, the second reason we want to use 2 doses is that there was no dose response in DAVIO 2. 2-milligram and 3-milligram worked essentially equivalently. And therefore, we want the opportunity to test the dose that’s around 2 milligrams in another dose that’s possibly lower, that would dose be delivered by a single insert. And we hope to and expect to power the trial enough that the lower dose could show non-inferiority against the aflibercept control group.

Operator: Thank you. One moment for our next question. Our next question comes from Yale Jen with Laidlaw & Company. Your line is open.

Yale Jen: Good morning. Thanks for taking the question. Just for the DME, I know it’s probably a little bit later to happen. And in terms of 1901, what its real complaint any differently in terms of the potential paradigm differences between the DME and with the wet AMD?

Jay Duker: Thanks, Yale. That’s a really good question, and it speaks to the differentiation in the two diseases of how they respond to anti-VEGFs. DME patients do respond to anti-VEGFs. But the anatomic response is often delayed and takes multiple injections to actually see that response. Therefore, a sustained release insert like EYP-1901 might not show a response faster than an anti-VEGF but we would expect and hope that if the population of diabetics respond the same way that the wet AMD population responds, that we can show a similar benefit to other anti-VEGF agents with a significantly reduced treatment burden. That would be the goal.