Opus Genetics: FDA Grants RMAT Designation To OPGx-LCA5

(RTTNews) - Opus Genetics (IRD) announced the FDA has granted Regenerative Medicine Advanced Therapy designation to OPGx-LCA5, its investigational gene therapy for the treatment of Leber Congenital Amaurosis due to genetic variations in the LCA5 gene. The RMAT designation for OPGx-LCA5 is based on early clinical evidence from Opuss ongoing Phase 1/2 open-label, dose-escalation trial.

The RMAT designation program offers the potential for expedited development and review of regenerative medicine therapies that demonstrate the potential to address serious or life-threatening diseases based on preliminary clinical evidence.

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