SUMMITS EXCIMER PHOTOTHERAPEUTIC KERATECTOMY LASER
This article was originally published in The Gray Sheet
Executive Summary
SUMMITS EXCIMER PHOTOTHERAPEUTIC KERATECTOMY LASER should not be indicated for recurrent erosions, FDA's Ophthalmic Devices Advisory Panel concluded at its March 21 meeting. The panel voted 9-1 in favor of the firm's excimer laser for the treatment of patients with pathologic corneal conditions sufficiently severe to adversely affect visual acuity and/or cause discomfort. The recommendation for approval specifically excluded Summit's "listed indications...for recurrent erosions" after panel members zeroed in on the absence of a control study group.