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News about "FDA alignment"
Opus Genetics Aligns with US FDA on Phase 3 OPGx-LCA5 Trial
Opus Genetics has aligned with the US Food and Drug Administration (FDA) on the Phase 3 trial design for OPGx-LCA5 in inherited retinal disease, with phase 3 dosing expected in Q4 2026 and a potential Biologics License Application (BLA) submission based on 6-month efficacy data.
FDA Alignment | 07/07/2026 | By News Bureau
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