Opus Genetics Confirms FDA Alignment On Phase 3 Study Design To Evaluate OPGx-LCA5

(RTTNews) - Opus Genetics (IRD) has reached alignment with the FDA in a Type B Rare Disease Evidence Principles meeting on the design of its registrational Phase 3 clinical trial evaluating OPGx-LCA5 for LCA5-associated inherited retinal disease. The company has received the meeting minutes from the Type B meeting confirming several key elements of the trial. The FDA indicated that Opus Genetics may submit a Biologics License Application based on efficacy at the six-month primary endpoint, with 12-month durability data submitted during the BLA review process.

The Phase 3 study is expected to enroll eight participants. Seven of the eight planned participants have already been enrolled and are currently completing the run-in period, and the company expects to initiate dosing in the fourth quarter of 2026.

In pre-market trading on NasdaqCM, Opus Genetics shares are up 2.55 percent to $4.3378.

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