Floretina 2025: study shows reduced treatment burden with EYP-1901 for neovascular AMD
Samuel Minaker, MD, MSc, of Tyler Retina Consultants, presented data at the Floretina 2025 meeting in December showing that EYP-1901 reduced the treatment burden in patients with neovascular age-related macular degeneration.
Samuel Minaker, MD, MSc:
Hi, I’m Sam Minaker. I’m a retina specialist and director of clinical research at Tyler Retina Consultants. This past week, I was at the Floretina meeting in Florence where I presented some data from the DAVIO-2 trial. What I presented was visual outcomes as well as treatment burden for patients treated with EYP-1901 versus on-label aflibercept, and presented some data assessing a single dose of EYP-1901 versus every 8-week aflibercept looking at outcomes at month 7 and 8 following a single dose.
In terms of the DAVIO-2 trial, it was a phase 2 clinical trial looking at 2 different doses: 2 mg and 3 mg EYP-1901 compared with aflibercept every 8 weeks. The primary endpoint was best corrected visual acuity blended at month 7 and 8. Patients could be treated per a pre-specified criteria or at investigator discretion. This group of patients was heavily treated before. They had 10 injections on average in the past year, which for our patients with wet macular degeneration is a significant amount.
Their vision, on average, entering the study was approximately 20/32 Snellen. DAVIO-2 did meet its primary endpoint and there was no significant difference between the 3 groups in terms of BCVA at month 7 and 8. What was remarkable was the reduction in treatment burden. If you remember, these were patients that, on average, had 10 injections per year, and so they had about 5 injections in the 6 months leading up to being in the trial. But after a single dose of EYP-1901, their injection burden was reduced from approximately 5 injections to really less than 1. Then when we look at swim lane data for individual patients where their journey was looking at before the study and then during the study, there was over an 85% reduction in the treatment burden, which is huge for these patients. In terms of safety, there was no safety signals at all.
This compounds on 4 other clinical trials evaluating EYP-1901, where there were no systemic or ocular adverse events. This is an insert that’s put into the eye and there was no migration to the anterior chamber and no cases of retinal vasculitis. In terms of what does this lead to, the current phase 3 program for EyePoint, for wet macular degeneration, LUGANO is expected to present data in mid-2026 with LUCIA to follow.
During the session, we also discussed what is EYP-1901, and this study really led to the development of what is now DURAVYU. This is an intraocular insert that’s bioerodible, that provides sustained-release dosing of vorolanib, a potent TKI that provides pan-VEGF receptor inhibition. It provides platelet-derived growth factor inhibition, and then via JAK1, it actually inhibits IL-6, which is pro-inflammatory. When it’s administered within hours, it reaches the target tissue having an effect. Then unlike some other TKIs, it fully bioerodes where there’s no free-floating drug at the end of the 6 months, and then there’s no PLGA or PEG that’s utilized in the implant.
Then based on its design, it can be shelf-stable, doesn’t require any cold storage, and comes in a pre-filled intravitreal injector. The discussion during the session talked a lot about the mechanism of action, which is unique for vorolanib and DURAVYU. When you think about wet macular degeneration, one of the really unmet needs is patients that develop fibrosis or the inflammatory component of the disease and both platelet-derived growth factor as well as IL-6 mediate that. Potentially, that plus just consistent dosing may modify some fibrosis that we see in wet AMD patients, and people are interested to see it in future studies of either the DAVIO-2 cohort or in the phase 3 program, if that will bear up. It’s something that we’re very excited about.
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