Clinical Trial SuccessPositive two-year efficacy data from the ongoing Phase 1/2 study demonstrated that in 100% of evaluable patients the treatment with OCU400 achieved improvement or preservation of visual function compared to untreated eyes, indicating both efficacy and durability.
Regulatory ProgressThe FDA lifted the clinical hold on OCU200's IND for a Phase 1 study targeting Diabetic Macular Edema, which indicates regulatory progress.
Regulatory SupportOCU400 received Advanced Therapy Medicinal Product (ATMP) classification from the EMA which indicates a vote of confidence from the regulators and could potentially accelerate the regulatory review timeline.