$IRD (OPUS GENETICS) — 8-K: OPGx-BEST1 low dose shows visual gains in 5 of 5 patients; FDA aligns on pivotal endpoint

Opus Genetics reported positive 3- and 6-month results from Cohort 1 of the Phase 1/2 BIRD-1 trial of OPGx-BEST1 in BEST1-related retinal diseases. All five participants demonstrated clinically meaningful improvement in visual function, with structural improvements in four participants and no serious adverse events or dose-limiting toxicities. FDA aligned on 3 decibels microperimetry improvement with patient reported outcomes as a potential pivotal endpoint. Cohort 2 dosing is expected to complete in Q4 2026, with topline 3-month data in Q2 2027, and cash runway into 2029.

Opus Genetics reported positive 3- and 6-month results from Cohort 1 of the Phase 1/2 BIRD-1 trial of OPGx-BEST1 in BEST1-related retinal diseases. All five participants demonstrated clinically meanin