Avedro Gets Feb. 24 Joint Review for Corneal Collagen Cross-Linking Treatment

Boston-based Avedro said Tuesday that the FDA has set a Feb. 24 review date for its KXL corneal collagen cross-linking system, which uses ultraviolet A irradiation to activate riboflavin ophthalmic solutions to treat conditions caused by thinning or bulging of the cornea following refractive surgery.

The application for the combination product, based on data from three 12-month randomized U.S. trials, will be considered by the Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel.

Collagen cross-linking is a procedure designed to strengthen the cornea. A riboflavin solution is applied once to the eye and activated via UV-A light.

The KXL cross-linking system received orphan drug designation for karatoconus and ectasia following refracting surgery. If approved, the product would enjoy seven years of market exclusivity for those indications. — Kellen Owings