The following transcript has been edited for clarity.
Hi, this is Ashkan Abbey, MD, FASRS, FAAO, from Texas Retina Associates in Dallas, Texas. I’m attending Retina World Congress this week, and I’ll be presenting an update on the Duravyu clinical trial program (EYP-1901; EyePoint Pharmaceuticals). Duravyu is a bioerodible intravitreal insert for retinal exudative diseases, including wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
EYP-1901 is an intravitreal insert designed to provide sustained release of the tyrosine kinase inhibitor (TKI) vorolanib, which works intracellularly to inhibit pan-VEGF receptor signaling. It also inhibits PDGFR and blocks inflammatory IL-6 signaling through the JAK pathway.
It has the potential to provide long-term visual and anatomic stability in wet AMD and DME with fewer injections over time compared with standard anti-VEGF bolus dosing. The phase 3 programs are evaluating dosing approximately every 6 months.
An important feature of vorolanib is that it works intracellularly against all VEGF receptors. In the Duravyu insert, the drug delivery system is bioerodible, contains no PEG or PLGA, and is designed for drug release over approximately 6 to 9 months. There are also no free-floating drug particles associated with the insert.
The Duravyu clinical trial program is one of the most robust TKI programs in retina. The phase 1 DAVIO trial evaluated a single injection of EYP-1901 in patients with wet AMD and primarily established safety. That was followed by the phase 2 DAVIO 2 trial, which showed a significant reduction in treatment burden with EYP-1901 compared with aflibercept 2 mg (Eylea; Regeneron) every-other-month dosing after 3 loading doses. After 1 year of treatment, DAVIO 2 also demonstrated statistically noninferior changes in best-corrected visual acuity (BCVA) at both 6 months and 1 year.
The phase 2 VERONA trial evaluated EYP-1901 in DME. Patients received a single injection and were followed with retreatment based on prespecified rescue criteria. The study demonstrated an early effect on DME, including responses seen as early as 1 month after injection. That finding suggested the drug does not necessarily require a prolonged buildup period before producing a therapeutic effect. The trial also demonstrated reductions in treatment burden and statistically noninferior changes in BCVA, supporting advancement into phase 3 DME studies.
The current phase 3 wet AMD trials are LUGANO and LUCIA. These studies are ongoing, with top-line data anticipated within approximately the next 3 to 6 months. The phase 3 DME studies are COMO and CAPRI, which were initiated more recently.
In the phase 3 wet AMD studies, patients are randomized either to receive 2.7 mg EYP-1901 after 3 loading doses of aflibercept or to receive aflibercept every other month after loading. Patients are followed monthly over 2 years and can receive supplemental treatment according to prespecified retreatment criteria.
The primary endpoint is the mean change in BCVA from baseline through the average of weeks 52 and 56 compared with aflibercept control. Secondary endpoints include treatment burden reduction, safety, and the percentage of eyes remaining supplement injection free.
For COMO and CAPRI, the design is going to be EYP-1901 dosing at day 1 in 50% of the patients. Patients in the aflibercept control group will receive aflibercept at that visit plus a sham injection of EYP-1901. Then patients will receive 2 additional doses of monthly aflibercept in the EYP-1901 group, and a total of 5 doses of monthly aflibercept in the control group. Patients are then followed monthly, with retreatment based on prespecified criteria that involve BCVA and worsening edema.
In this trial, we'll be looking at the difference in mean change of BCVA from day 1 to week 52 and 56, averaged again, vs the aflibercept control, while also looking at safety and the reduction of treatment burden.
We will be expecting the readout of the phase 3 trials, probably at the American Academy of Ophthalmology (AAO) meeting [October 9-12, 2026], for LUGANO and LUCIA, for wet AMD. The COMO and CAPRI readout is going to in the second half of 2027, because we are just starting those trials now.
To summarize, the EYP-1901 program has demonstrated encouraging durability signals in both wet AMD and DME. Across DAVIO, DAVIO 2, and VERONA, the studies showed early and sustained visual and anatomic outcomes with reductions in treatment burden over time. Importantly, the program has also shown a favorable safety profile to date, with no related ocular or systemic serious adverse events reported in these studies.
Thank you for your attention, and we look forward to seeing you at Retina World Congress. RP