Opus Genetics: OPGx-BEST1 helps 75% of evaluable patients; OPGx-LCA5 Phase 3 dosing set for Q4 2026

Opus Genetics, Inc.

OPGx-BEST1 low-dose Cohort 1 (1.5E9 vg/eye): 3 of 4 evaluable patients (75%) improved retinal sensitivity in the treated transitional zone, 3-6 months follow-up.
High-dose Cohort 2 (4.5E9 vg/eye) fully enrolled with 11 participants; FDA aligned on a >=3 dB gain at >=5 loci in treated transitional zone as endpoint.
OPGx-LCA5 Phase 1/2 at 1E10 vg/eye: 3 adults sustained visual acuity and light sensitivity gains through 24 months; 3 pediatric patients improved through 6 months.
OPGx-LCA5 Phase 3 natural-history and treatment cohorts fully enrolled; dosing expected Q4 2026, primary endpoint retinal sensitivity across 16 central test locations.
OCT EZ-to-RPE thickness rose ~11.1 um in treated eyes vs 1.5 um in untreated fellow eyes by Day 90 in 3 participants; BEST1 US prevalence ~23,600.

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