EyePoint Reports Positive Interim Data From Phase 1 Trial Of EYP-1901 On Wet AMD Treatment

(RTTNews) - EyePoint Pharmaceuticals Inc. (EYPT) announced positive interim safety and efficacy data from phase 1 DAVIO clinical trial evaluating EYP-1901 for the Treatment of wet age-related macular degeneration.

The interim six-month results showed positive safety data, no dose limiting toxicities, no ocular serious adverse events (SAEs), and no drug-related systemic serious adverse events.

The data showed 76% and 53% of patients did not require rescue following a single dose of EYP-1901 up to four and six months, stable and sustained BCVA (-2.5 letters) and CST (-2.7 µm), a 79% reduction in treatment burden at six months, and a median time to rescue of six months across all patients.

The Phase 1 DAVIO clinical trial is an open-label, dose escalation clinical trial of EYP-1901 that enrolled 17 patients with previously treated wet age-related macular degeneration.

EYP-1901 is a sustained delivery anti-VEGF (voralanib) investigational treatment that utilizes a bioerodible formulation of EyePoint's Durasert drug delivery technology that has been utilized in four FDA-approved products, including EyePoint's YUTIQ for chronic non-infectious uveitis affecting the posterior segment of the eye.

EyePoint plans to initiate a Phase 2 wet AMD clinical trial in 2022 and the company has scheduled a Type C meeting with the FDA on December 1, 2021, to discuss specific plans and obtain guidance on potential EYP-1901 registration trials.

The company also expects to initiate additional EYP-1901 clinical trials in diabetic retinopathy (DR) and retinal vein occlusion (RVO).