Ocugen has achieved significant regulatory milestones, including securing Orphan Drug Designations, Regenerative Medicine Advanced Therapy (RMAT) designations, and clinical trial authorizations from the United States Food and Drug Administration to advance its investigational gene therapy candidates through human clinical evaluations. However, the company has not yet secured final commercial FDA biologics license approval for its primary flagship gene therapy products, as its pipeline candidates remain active within ongoing clinical development phases.