Avedro yesterday said the FDA wants more data on its corneal cross-linking technology for treating 2 sight-threatening conditions, meaning the Boston-based medical device company is left with a longer U.S. approval timeline.
The FDA’s complete response letter for Avedro’s new drug application for its KXL system outlines "a number of small areas" that need new information, the company said. Avedro didn’t offer details, other than noting that regulators did not seek added information regarding clinical study safety or efficacy data included in the NDA.
The KXL system uses riboflavin ophthalmic solutions with UVA radiation to treat progressive keratoconus or corneal ectasia. The FDA’s move comes despite a late February joint meeting of its Dermatologic & Ophthalmic Drugs and its Ophthalmic Devices advisory panels, which recommended approval for the treatment for both conditions.
The federal safety watchdog is not bound by its advisory panels’ votes, but often follows their recommendations.
Avedro’s NDA is also backed by 3 clinical studies, and its KXL and KXL II Systems already have CE Mark approvals in the European Union, the company said.
"We are disappointed with the outcome of the review and the implications this has for patients in the U.S. suffering from keratoconus or corneal ectasia who remain in need of a therapeutic treatment for these sight-threatening conditions," CEO David Muller said in prepared remarks. "Despite this setback, we are diligently working to resolve these outstanding questions with the goal of making this vital treatment available as soon as possible."