On February 18, 2025, Opus Genetics, Inc. announced the dosing of the first pediatric patient in its ongoing Phase 1/2 clinical trial for OPGx-LCA5, an investigational gene therapy for Leber congenital amaurosis (LCA). Initial data from this pediatric cohort is anticipated by the third quarter of 2025.
The company also plans to present new 12-month data on the first three adult OPGx-LCA5 patients at a major medical conference in the second quarter of 2025. This data will build upon previously released 6-month data that showed meaningful visual improvement.
An FDA Type D meeting is scheduled for March 2025 to discuss the pivotal trial design and registrational endpoints for OPGx-LCA5. This meeting is a crucial step towards defining the path for a potential Phase 3 trial and eventual regulatory submission.
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