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Opus Genetics Announces FDA Acceptance of OPGx-LCA5 into Rare Disease Evidence Principles (RDEP) Program

$IRDPress releaseMay 4, 2026, 4:30 PM ETRead the release

Opus Genetics announced that the FDA accepted its OPGx-LCA5 program into the Rare Disease Evidence Principles (RDEP) initiative. This program supports therapies for ultra-rare diseases affecting fewer than 1,000 patients in the U.S. and enables early collaboration on trial design and evidence generation.

Key figures

Drug Name
OPGx-LCA5
Phase Of Trial
Phase 1/2
Us patient population
<1000

AI analysis

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    IRD: Opus Genetics Announces FDA Acceptance of OPGx-LCA5 into Rare Disease Evidence Principles (RDEP) Program — AI Analysis | Signal8