VibeX™ Riboflavin/KXL™ System for the Treatment of Keratoconus Granted Orphan Drug Designation
September 19, 2011
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Last week, Avedro, Inc. announced that the FDA had granted orphan drug designation to the company’s VibeX (0.1.% riboflavin ophthalmic solution) for use with its KXL System (UVA irradiation) for Corneal Cross-linking to treat Keratoconus.
Orphan-drug designation is granted by the FDA Office of Orphan Products Development to promote the development of new therapies for rare diseases and disorders affecting fewer than 200,000 individuals in the United States. Orphan drug designation may entitle Avedro to seven years of U.S. marketing exclusivity upon regulatory approval.
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