FEB 25, 2015
A joint panel of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel recommends approval of Avedro’s corneal cross–linking system for progressive keratoconus and corneal ectasia following refractive surgery.
Up for FDA consideration is Avedro’s drug-device combination of two riboflavin solutions, Photrexa Viscous (riboflavin ophthalmic solution with 20% dextran) and Photrexa (riboflavin ophthalmic solution with 0% dextran) and the KXL system(UVA light).
Due to concerns about the absence of data on the KXL device, the 15-member panel was mixed on the question of whether there is substantial evidence of efficacy and safety to support approval of the drug-device combination. The company’s IROC UV-X system was used in the clinical trial, not the KXL system. The vote was 10 to 4 (with 1 abstention) in support of approval for progressive keratoconus, and 6 to 4 (with 4 abstentions) for approval for corneal ectasia.
The FDA is expected to decide next month. If approved, Avedro’s system would be the first FDA-approved corneal cross-linking treatment for progressive keratoconus and corneal ectasia.. Avedro could be granted seven years of market exclusivity.