FDA grants priority review to cross-linking

Avedro says the FDA has granted priority review status to its new drug application for its riboflavin ophthalmic solution/KXL system, with a decision due by March 15, 2014.

If approved, riboflavin ophthalmic solution/KXL system would be the first FDA-approved treatment for keratoconus and corneal ectasia following refractive surgery. The company could be granted seven years of market exclusivity due to orphan drug designation.

“U.S. ophthalmic surgeons are thrilled that the FDA is considering this with priority review,” said Peter Hersh, MD, of the Hersh Vision Group in Teaneck, N.J., who is Avedro medical monitor. “If approved, cross‐linking could represent an important new treatment option for patients with keratoconus and ectasia.”

Avedro’s KXL System and single-dose pharmaceutical products are currently used in three Phase III U.S. clinical trials involving more than 100 clinical sites. The company’s products currently are not for sale in the U.S.