The European Commission has designated Orphan Medicinal Product status to Ocugen Inc's (NASDAQ: OCGN) OCU400 (AAV5-hNR2E3) to treat both retinitis pigmentosa (RP) and Leber Congenital amaurosis (LCA).
Orphan medicinal product benefits include protocol assistance, reduced regulatory fees, research grants, and ten years of market exclusivity following regulatory approval.