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Opus Genetics Announces FDA Clearance of IND Application for OPGx-RDH12 Gene Therapy for Inherited Childhood Blindness

$IRDPress releaseOct 21, 2026, 7:00 AM ETRead the release

The FDA cleared Opus Genetics' IND application for OPGx-RDH12, an AAV-based gene therapy for RDH12-associated Leber congenital amaurosis, a rare inherited retinal disease causing childhood blindness. The clearance lets the company advance its third gene therapy program into the clinic, with a Phase 1/2 trial planned to begin this quarter. The program is supported by the Global RDH12 Alliance, which committed up to $1.6 million in reimbursed development costs under a July 2025 venture-philanthropy collaboration.

Key figures

Drug Name
OPGx-RDH12
Deal Value Usd
1600000
Phase Of Trial
Phase 1/2
Pipeline programs
7
Collaboration commitment
up to $1.6 million from the Global RDH12 Alliance
Global rd12 lca population
30900

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