The treatment landscape for wet age-related macular degeneration (wAMD) is evolving significantly, with increasing attention on reducing the frequency of intravitreal injections needed to preserve vision. One of the most promising advancements in this area is the EYP-1901, a sustained-release formulation of vorolanib, a tyrosine kinase inhibitor (TKI) delivered via the Durasert platform, which is being investigated in the DAVIO 2 trial.
The DAVIO 2 trial, a multicenter, randomized, double-masked Phase 2 study, evaluated the efficacy and safety of a single intravitreal injection of EYP-1901 compared to aflibercept in patients previously treated for wAMD. Over a 12-month period, the results were highly encouraging: patients receiving EYP-1901 maintained stable visual acuity and demonstrated robust anatomical control. Notably, the treatment burden was reduced by 80%, a significant finding given that wAMD patients often face regular anti-VEGF injections to manage their disease.
A standout feature of EYP-1901 is its ability to deliver vorolanib in a sustained, controlled manner over several months. This extended-release profile translates to fewer required injections, which is a substantial benefit for patients who would otherwise need anti-VEGF treatments every 4 to 8 weeks. In the trial, half of the patients who received EYP-1901 were able to remain injection-free for the entire 12-month period, marking a major improvement in their quality of life by reducing the frequency of clinic visits and treatments.
Data from the trial’s subgroup analysis, presented at the 2024 Euretina Congress, further highlighted the consistency of EYP-1901’s efficacy across various patient groups. Regardless of differences in baseline visual acuity levels and treatment histories, patients receiving EYP-1901 exhibited similar outcomes to those treated with aflibercept. Specifically, the mean change in best-corrected visual acuity (BCVA) was nearly identical between both groups. Moreover, central subfield thickness (CST) changes were well-controlled, providing additional reassurance that the therapy effectively manages the underlying anatomical aspects of wAMD.
Beyond its efficacy, EYP-1901 demonstrated a strong safety profile. In the DAVIO 2 trial, there were no reports of serious ocular or systemic drug-related adverse events. This favorable safety record, combined with its sustained efficacy, positions EYP-1901 as a highly promising candidate for reducing the treatment burden in wAMD. Approximately 97% of reported adverse events were mild or moderate, consistent with expectations for intravitreal injections. Importantly, no instances of retinal occlusive vasculitis were observed, reinforcing the therapy’s strong safety profile.
As the DAVIO 2 trial advances to Phase 3, scheduled to begin in late 2024, EYP-1901 shows the potential to revolutionize wAMD treatment. By offering a long-lasting solution with fewer injections, it directly addresses one of the primary challenges in managing this chronic condition—the burden of frequent treatments. The success of EYP-1901 could usher in a new era for wAMD management, providing patients with a more convenient and sustainable way to preserve their vision and improve their quality of life.
Reference
David Aaron Eichenbaum, Vrinda Hershberger, Sunil S Patel, Ashkan Michael Abbey, W Zachery Bridges, Arshad M. Khanani, Stephanie Ruggiero, Monica Roy, Jay S Duker, Dario A Paggiarino; The DAVIO 2 trial: a phase 2, randomized, double-masked, controlled multicenter study of EYP-1901 vs aflibercept in previously treated wet age-related macular degeneration. Invest. Ophthalmol. Vis. Sci. 2024;65(7):4401.