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Opus Aligns With FDA On Phase 3 Study For OPGx-LCA5 In Treating IRD; Dosing To Begin In Q4

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Opus Genetics announced FDA alignment on the Phase 3 registrational trial design for OPGx-LCA5 in treating inherited retinal dystrophy (Type B Rare Dis). The regulatory agreement is a positive de-risking step for the company’s late-stage program, though no efficacy/safety or timeline update was provided in the excerpt.

Analysis

Opus Genetics announced FDA alignment on the Phase 3 registrational trial design for OPGx-LCA5 in treating inherited retinal dystrophy (Type B Rare Dis). The regulatory agreement is a positive de-risking step for the company’s late-stage program, though no efficacy/safety or timeline update was provided in the excerpt.

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