FDA delays decision on cross-linking product

Avedro Inc., reports that it has received a complete response letter from the U.S. Food and Drug Administration (FDA), requesting additional information on its riboflavin ophthalmic solution/KXL System.

If approved, the riboflavin ophthalmic solution/KXL System would be the first FDA-approved therapeutic treatment for keratoconus and corneal ectasia.

“We plan on working closely with the FDA to resolve these issues as quickly as possible to make this important treatment available to patients in the U.S.,” said David Muller, PhD, CEO of Avedro. “While we do not yet have an estimate on how long it will take to resolve the issues, we are confident that we can adequately answer their questions. However, we continue to grow internationally by bringing advanced corneal cross-linking procedures to ophthalmologists and patients around the world.”

Avedro’s cross-linking system is currently being studied in three phase III clinical trials involving more than 1,000 U.S. clinical sites. It has received the CE Mark for performing LASIK Xtra and Accelerated Cross-linking.