Opus Genetics Receives FDA Clearance for Childhood Blindness Gene Therapy Trial

Key Facts

1The U.S. FDA cleared the Investigational New Drug (IND) application for OPGx-RDH12, a gene therapy for inherited retinal disease.

The U.S. Food and Drug Administration (FDA) cleared the Investigational New Drug (IND) application for Opus Genetics to begin clinical trials of its OPGx-RDH12 gene therapy. GlobeNewswire reported that the clearance enables the company to advance into clinical development for a treatment targeting RDH12-associated Leber congenital amaurosis, a rare condition causing vision loss in children.

IRD closed at $4.01 on October 20, 2026, with the stock trading between a day low of $3.78 and a high of $4.14 during that session. This regulatory milestone marks a significant step in the company's efforts to develop AAV-based gene therapies, reinforcing its pipeline for rare inherited retinal diseases.