Background Analysis: US FDA Joint Advisory Committee to Review Avedro’s VibeX/KXL System to Treat Rare Corneal Disorder Following LASIK – FEB 24, 2015 (DODAC)
The US FDA has scheduled a Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and the Ophthalmic Devices Panel of the Medical Devices Advisory Committee for Tuesday, February 24, 2015 to discuss new drug application (NDA) 203324, for riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc (Avedro), a private pharmaceutical company based in Boston, Massachusetts. The combination products are used in corneal collagen cross-linking and proposed to be indicated for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.