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Orphan Drug Designations in Ophthalmology
William C. Stewart, Shilla Marie Hernandez, Jeanette A. Stewart RN and Lindsay A. Nelson BS
Purpose: To evaluate orphan drug designations within ophthalmology since passage of the Orphan Drug Act and their ultimate availability and utility to the ophthalmic community.
Methods: The study design was a retrospective, observational review of orphan drug designations in ophthalmology.
Results: We identified 72 new ophthalmic drugs that received an orphan drug designation, of which four received NDA approval and all became commercially available, three for ocular and one for systemic indications.
Conclusions: This study suggests a low rate of commercialization of new ocular pharmaceutical agents with an orphan designation being approved for the original indication.