Results Wire: US FDA Advisory Committee Splits Votes on Avedro’s Photrexa/KXL System to Treat Progressive Keratoconus and Corneal Ectasia – FEB 24, 2015 (DODAC)

On Tuesday, February 24, 2015, the Joint Meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) and the Ophthalmic Devices Panel of the Medical Devices Advisory Committee Advisory Committee split their votes on the safety and efficacy of combination product riboflavin ophthalmic solutions with UV-A irradiation, submitted by Avedro, Inc (Avedro).

Regarding the recommendation for the combination product’s approval for corneal collagen cross-linking in the treatment of progressive keratoconus, the Committee voted 10-Yes to 4-No, with 1 abstention. For the indication of treatment for corneal ectasia following refractive surgery, the Committee voted 6-Yes to 4-No, with 4 abstentions and 1 Committee member not voting.

See the SAC Tracker Report