Joint Panel Recommends FDA Approval for Drug-Device Combination for CXL for Progressive Keratoncus and Corneal Ectasia

Yesterday, a joint panel of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel voted to recommend approval of Avedro’s (Waltham, Mass.) drug-device combination of riboflavin ophthalmic solution and UV-A light for crosslinking for both progressive keratoconus and corneal ectasia following refractive surgery.

The panel voted on the question “Has substantial evidence of efficacy and safety been demonstrated for the drug-device combination of Photrexa Viscous and Photrexa (riboflavin ophthalmic solution) and the KXL System (UVA light) to support approval?” twice, once regarding progressive keratoconus and once regarding corneal ectasia following refractive surgery. Results for the progressive keratoconus vote were 10 yes, 4 no, and 1 abstained. Results for the corneal ectasia following refractive surgery vote were 6 yes, 4 no, 4 abstained, and 1 was not present.

The panel heard testimony from both the sponsor and the FDA before moving on to public testimony. Concerns were expressed from the panel members regarding the study protocol and data. However, in the end the panel members recognized the medical need for this procedure to be available to patients in the United States.

Thomas John, MD, Tinley Park, Ill., spoke on behalf of ASCRS as a member of the ASCRS Cornea Clinical Committee. ASCRS' testimony supported the approval of corneal collagen crosslinking [CXL] for the treatment of ectatic corneal disease.

Dr. John's testimony noted that the peer-reviewed literature, including uncontrolled observational trials and well-conducted prospective clinical trials, as well as the personal experience of many of our members, demonstrate the safety and efficacy of CXL.

We will continue to keep you updated on this issue and will let you know once FDA decides whether to approve Avedro’s drug device combination of riboflavin ophthalmic solutions and UV-A light for crosslinking for these indications. If you have any questions, please contact Ashley McGlone at 703-591-2220.