Expert Insights: Ramiro Ribeiro, MD, PhD, discusses next steps in EYP-1901 research

Video Transcript:

Editor's note: The below transcript has been lightly edited for clarity.

Ramiro Ribeiro, MD, PhD: Sure So at Hawaiian Eye, we gave an update on our phase 2 program, the Davio-2 study, that is the largest TKI program in wet AMD to date, with the results. We enrolled about 150 patients that receive either [EYP]-1901 high dose, [EYP]-1901 low dose, and control arm was aflibercept. All patients received 3 loading doses [of] aflibercept in the beginning of the study, and were those with DURAVYU, EYP-1901, had week eight. The study met the primary endpoint, which was nonferiority with comparing DURAVYU, again [EYP]-1901, with aflibercept at the average 28/32 weeks that again showed no difference in BCVA between the groups.

Very important, the patients that received [EYP]1901, approximately 50% of them did not require any supplemental injection with anti-VEGF, and they saw a reduction in treatment burden of about 80%, and that's where we see, you know, the true value of this therapy is really maintaining vision while reducing treatment burden for patients. We also did a quick recap on our DME program. We have the phase 2 study called the VERONA trial. In that study, we had again, 3 groups, EYP-1901 high dose, EYP-1901 low dose, and aflibercept. Patients, at day one, everybody got one aflibercept, and then they got the aflibercept plus EYP-1901 high dose, aflibercept plus EYP-1901 low dose, or aflibercept plus Sham.

So we had the interim 16-week results for that study, and we showed that patients on high dose EYP-1901, they experience gain vision that was about 6 letters appeared to aflibercept alone, and also a great reduction in CST with that study allow the use of supplemental aflibercept, so patients on EYP-1901, they had less supplement injection compared to the aflibercept arm. We also gave a quick update in our phase 3 studies that are currently ongoing, LUGANO and LUCIA. So those are studies for wet AMD. This study is recruiting patients now in the US, it's going really well. We have enrolled over 1/3 of the patients for the LUGANO study, exceeding our expectations. And the LUCIA trial, that started a little bit after LUGANO, also is going ahead of schedule. So we're quite excited again for the results on our phase2 programs, both in wet AMD and DME, but also very important, how the phase 3 programs are going and excitement with the retina community.

Sydney M. Crago: What is the the continued monitoring or the dataset look like going forward?

Ramiro Ribeiro, MD, PhD: Yeah, so DAVIO-2, the phase 2 study for wet AMD, that study was completed. So, we presented the full data. For DME, that study is 24 weeks. So we presented interim data at 16 weeks, and we expect the results of the complete study, 24 weeks, sometime this quarter. So should be coming soon. You know, we are very optimistic about the results of that study because of what we saw at week 16. In terms of development going forward for DME, we're now going to start to think about the phase 3 study protocol and interaction with the FDA, EMA later this year. And then, you know, kind of study steps for that program. It's a combination of a drug delivery system, the Durasert E with voroanib, which is a small TKI.

I think what we have in our advantage is that we have a lot of expertise, EyePount drug delivery system with to research. We use the similar technology in other products, and now we have the bioeriodable form of Durasert, which is in combination of TKI. So that one aspect that is very important for folks to remember, and the second one is that the TKI, in a way, it's a different method of action from what we're used to with anti-VEGFs. It works intracellularly, blocking the receptors. We have to think about this as not as an anti-VEGF replacement, but working together with the anti-VEGF. Again, the goal for us is to provide good vision for patients while we reduce the treatment burden.

So that's kind of the take away for the model itself. When we think about the studies, we show a very control, randomized it's the largest study in TKI, for wet AMD, DAVIO-2 study, where we show patients having a preserved vision and a reduction in treatment burden. For the first time, with the DME study, we were able to show the immediate therapeutic effect we have with Durayvu, because we saw where those patients day one, at week four, we already saw a great improvement in BCVA with compared to aflibercept alone.

So that was a very important takeaway from that study to again show that TKI, especially in our case, is available as soon as you inject and reach therapeutic levels again after inject into the vitreous cavity. So