Opus Genetics, Inc. — Form 8-K

Opus Genetics announced positive 3- and 6-month results from low-dose Cohort 1 (5 participants) of its BIRD-1 Phase 1/2 trial of OPGx-BEST1 for BEST1-related retinal diseases. All 5 participants showed clinically meaningful visual improvements with no serious adverse events; 75% met the FDA-aligned microperimetry endpoint (≥3 dB improvement in ≥5 loci). In August 2026, FDA aligned on this microperimetry endpoint plus patient-reported outcome as potential pivotal trial endpoint. Cohort 2 (8 participants, higher dose 4.5×10⁹ vg/eye) is over-enrolled with dosing expected Q4 2026 and 3-month data Q2 2027; Phase 3 dosing expected 2027. Cash runway extends into 2029.