Market PotentialDME remains a significant area of unmet need with 30%-40% of patients not responding to standard therapy, indicating a large potential market for OCU200.
Regulatory ConfidenceOCU400 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.
Regulatory ProgressThe FDA lifted the clinical hold on OCU200's IND for a Phase 1 study targeting Diabetic Macular Edema, which indicates regulatory progress.