Briefing Summary: US FDA Posts Advisory Committee Materials for Avedro’s VibeX/KXL System to Treat Rare Corneal Disorder Following LASIK – FEB 24, 2015 (DODAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday, February 24, 2015 Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee and the Ophthalmic Devices Panel of the Medical Devices Advisory Committee. The joint committee will 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.