ASRS 2025: Vision outcomes from the DAVIO 2 trial

Jennifer Lim from the University of Illinois at Chicago presented the DAVIO-2 study, a non-inferiority clinical trial comparing EYP-1901 to aflibercept for treating neovascular age-related macular degeneration (AMD).

The study design involved 3 randomized arms: a low-dose EYP-1901 (2 mg), a high-dose EYP-1901 (3 mg), and aflibercept, which was administered every 8 weeks after 3 initial loading doses. Patients were permitted supplemental aflibercept based on pre-specified criteria throughout the one-year study period. The primary endpoint focused on measuring best-corrected visual acuity at weeks 28 and 32.

Notably, despite receiving only 1 dose, the EYP-1901 arms demonstrated non-inferior vision compared to the aflibercept arms receiving repeated treatments. Lim highlighted several key characteristics of the EYP-1901 drug. It was bioerodible and non-peglated, capable of providing a sustained, zero-order kinetic release over 6 months. This unique property suggested potential for reducing treatment frequency for patients.

The study participants were particularly complex, having previously undergone treatment for neovascular AMD. On average, they had received 10 anti-VEGF injections in the year preceding enrollment, classifying them as high-need patients. The research's implications were significant for future treatment strategies. The ongoing phase 3 study, which was fully enrolled at the time of presentation, planned to dose patients every 6 months based on the promising phase 2 results. Lim emphasized that the study offered potential for a new treatment option that could minimize the need for frequent re-injections, potentially improving patient experience and treatment adherence in managing neovascular AMD. The primary action item was to await the results of the phase 3 study, which would provide further insights into the efficacy and long-term performance of EYP-1901 as a treatment for neovascular AMD.