JUL 20, 2016
Cornea/External Disease, Refractive Mgmt/Intervention
The FDA has approved Avedro’s 2 riboflavin solutions and corneal collagen cross-linking (CXL) device for the treatment of corneal ectasia following refractive surgery. The decision follows the FDA’s long-awaited approval of Avedro’s system for keratoconus in April 2016.
The approval includes the riboflavin ophthalmic solution Photrexa, Photrexa Viscous (a riboflavin solution containing dextran) and an electronic device (KXL System) that irradiates the solutions with ultraviolet A light after they have been applied to the cornea. Photrexa products are projected to be available this Fall.
Approval was based on data from 3 prospective, randomized, parallel-group, open-label, placebo-controlled, 12-month trials which showed that treated eyes experienced improved Kmax at 12 months compared with untreated eyes which continued to worsen. At month 12, average maximum Kmax values lowered by 1 D and 0.5 D in the 2 Photrexa groups, while participants in the sham groups showed an increase in Kmax values.
The most common adverse reactions were corneal haze, corneal epithelium defect, corneal striae, and dry eye, among others. In 6% of patients, corneal opacity remained present at the trial endpoint.
“This much anticipated availability of an FDA-approved corneal collagen cross-linking therapy fills an unmet need in our ability to best treat our patients,” said Peter Hersh, MD, Avedro medical monitor. “This new approval will help to ensure that this important therapy is available to patients who need it.”