FDA
26th February 2015

FDA Panel Recommends Approval of Riboflavin, UV

The system is indicated for progressive keratoconus and corneal ectasia following refractive surgery. 

FDA Panel Recommends Approval of Riboflavin, UV

On Tuesday, a joint panel of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel voted 10-4 (with 1 abstention) to recommended approval of Avedro’s combined riboflavin ophthalmic solutions and ultraviolet light irradiation for corneal collagen cross-linking. The materials for this meeting can be found HERE

The system is indicated for progressive keratoconus and corneal ectasia following refractive surgery. The panel voted on the combined riboflavin solutions and UV irradiation for both indications.

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.

Temporary member Michael W. Belin, MD voted “no,” stating that, “just based on this study, I think it was a poorly done study, and I don’t understand why, when they took over the data 5 years ago and realized it was poor, they didn’t do an additional arm to validate the data.”

During the open public hearing session, several speakers referred to reports of adverse events resulting from LASIK and questioned the incidence of keratoconus. Others, including Stephen G. Slade, MD, OSN Refractive Surgery Board Member, voiced strong support for cross-linking.

The FDA is not obligated to follow the advice of its advisory committee panels, but normally does so.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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