FDA panel recommends approval for KXL System + combined riboflavin for corneal ectasia and ketatoconus- Avedro

The FDA�s Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel recommended approval of combined riboflavin ophthalmic solutions and ultraviolet light irradiation for corneal collagen cross-linking from Avedro.Photrexa Viscous (riboflavin ophthalmic solution with 20% dextran)/Photrexa (riboflavin ophthalmic solution with 0% dextran) with the KXL system (UVA light) is the first cross-linking treatment to be considered for approval in the U.S. On the question of whether there is substantial evidence of efficacy and safety to support approval of the solutions and UV irradiation for corneal ectasia following refractive surgery, six panel members voted yes, four voted no, four abstained and one member, Belin, did not vote. The riboflavin solutions and UV irradiation device are indicated for progressive keratoconus and corneal ectasia following refractive surgery.

Corneal collagen cross-linking is a medical procedure that combines the use of ultra-violet light and riboflavin eye drops. The procedure was first developed by Dr. Theo Seiler, Dr. Eberhard Spoerl and Dr. Gregor Wollensak in the late-1990s as a means of stabilizing the cornea to limit the progression of keratoconus and has been widely adopted as a conservative treatment for the condition as well as for iatrogenic ectasia.