EyePoint announces developments on DURAVYU

EyePoint Pharmaceuticals announced the Company will highlight clinical and regulatory developments for its lead pipeline program, DURAVYU, formerly known as EYP-1901, its Durasert E sustained drug delivery technology, and early-stage programs during EyePoint’s R&D Day. R&D Day Highlights: Phase 3 plans for DURAVYUTM in wet AMD, including key design elements of the Phase 3 LUGANO and LUCIA pivotal trials: Alignment on pathway to approval with U.S. Food and Drug Administration based on positive End of Phase 2 meeting for two non-inferiority trials, 6-month redosing of DURAVYU and sham for masking with a one-year endpoint. The LUGANO trial remains on track to initiate in 2H 2024 with LUCIA to follow. Positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYUTM for the treatment of wet AMD: Favorable safety profile; statistically significant visual acuity outcomes with both DURAVYU arms change in visual acuity nearly identical to aflibercept control arm through 12 months after a single injection of DURAVYU; Strong anatomical control through 12 months after a single injection of DURAVYU. The VERONA trial, a Phase 2 trial of DURAVYUTM in diabetic macular edema patients has completed enrollment with 27 patients assigned to one of two intravitreal doses of DURAVYU or an aflibercept control. To date, DURAVYU is well-tolerated with no reported drug-related ocular or systemic serious adverse events in this trial.