Avedro said the FDA granted priority review to the new drug application for its riboflavin ophthalmic solution used with its KXL system.
The priority review for the Waltham, Mass.-based medical device company draws Avedro closer to treating keratoconus and corneal ectasia. Keratoconus is a potentially blinding disease, for which limited therapeutic treatment is available in the US. Corneal ectasia is a rare outcome of refractive surgery but is a progressive condition that is difficult to manage, according to a press release.
If approved, the riboflavin ophthalmic solution and KXL system would be the first FDA-approved therapeutic treatment for these orphan indications, according to the release.
“U.S. ophthalmic surgeons are thrilled that the FDA is considering this with priority review. If approved, cross-linking could represent an important new treatment option for patients with keratoconus and ectasia,” Avedro medical monitor Dr. Peter Hersh said in prepared remarks.