08:28 AM EDT, 08/18/2025 (MT Newswires) -- Opus Genetics ( IRD ) said Monday that the Investigational New Drug application for its OPGx-BEST1 gene therapy to treat bestrophin-1-related inherited retinal diseases was approved by the US Food and Drug Administration

Following the approval, the company said it intends to start a phase 1/2 clinical trial in H2 2025 to evaluate the safety, tolerability, and preliminary efficacy of a single subretinal injection of OPGx-BEST1 in individuals with bestrophin-1-related inherited retinal diseases.

Opus Genetics ( IRD ) added that the study will also explore biological activity through functional and anatomical endpoints, including changes in visual function and retinal structure.

Shares of the company were up 1.7% in recent Monday premarket activity.