Avedro resubmits CXL application to FDA

In response to questions from the U.S. Food and Drug Administration (FDA), Avedro, Inc., has resubmitted its New Drug Application for riboflavin ophthalmic solution/KXL System for progressive keratoconus and corneal ectasia following refractive surgery.

The company says it anticipates a decision on its application in March 2015. If approved, the product would be the first FDA-approved therapeutic treatment for these orphan indications and entitle Avedro to seven years of U.S. market exclusivity.

“We have been working closely with the FDA to address the issues raised in the complete response letter,” said David Muller, PhD, CEO of Avedro.

The KXL System and Avedro’s single-dose pharmaceutical products are under investigation in three phase 3 clinical trials at more than 100 locations in the United States. The KXL System's cross‐linking, in combination with Avedro’s pharmaceuticals, is used to treat keratoconus and corneal ectasia outside of the United States.