FDA Wants More Info on Avedro's Corneal Cross-Linking NDA

Megan Brooks

March 20, 2014

Avedro Inc has received a complete response letter from the US Food and Drug Administration (FDA) regarding their new drug application (NDA) for riboflavin ophthalmic solution/KXL System to treat keratoconus and corneal ectasia after refractive surgery.

"In the complete response letter the agency identified a number of areas of the application which require additional information," the company announced March 18.

In a statement, Avedro Chief Executive Officer David Muller, PhD, said the company would work closely with the FDA to resolve these issues as quickly as possible to make the treatment available to patients in the United States.

"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," Dr. Muller said.

The FDA granted orphan drug status to riboflavin ophthalmic solution/KXL System for treatment of keratoconus and corneal ectasia after refractive surgery in 2011, as reported by Medscape Medical News.

Keratoconus is a potentially blinding disease with limited treatment options in the United States, the company notes. Corneal ectasia is a rare outcome of refractive surgery, such as Lasik, and is a progressive condition that is hard to manage.

"Patients with these sight threatening conditions may require corneal transplant surgery. If approved, the riboflavin ophthalmic solution/KXL System would be the first FDA-approved therapeutic treatment for these orphan indications," the company said.

The treatment works by strengthening the cross-links between fibrils that serve as "natural anchors" within the cornea.

The KXL system is approved outside the United States, where 75,000 surgeries have been performed successfully, according to the company.

Avedro received priority review status on the NDA in November 2013.

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