Opus Genetics Announces FDA Alignment on Phase 3 Registrational Trial Design for OPGx-LCA5 in LCA5-Associated Inherited Retinal Disease
Opus Genetics reached alignment with the FDA on the Phase 3 design for OPGx-LCA5, allowing for a BLA submission based on 6-month efficacy data with 12-month durability data to follow during review. The registrational trial plans to enroll eight participants using a six-month run-in period as a natural history control, with seven patients already enrolled and dosing anticipated to begin in the fourth quarter of 2026.
Key figures
- Drug Name
- OPGx-LCA5
- Phase Of Trial
- Phase 3
- Participants total
- 8
- Dosing start quarter
- 4Q 2026
- Run in period months
- 6
- Participants enrolled
- 7
- Pipeline programs count
- 7
- Phase 1 2 improvement db
- 10.5
- Statistical power percent
- > 90
- Primary endpoint db improvement
- 7
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