Avedro Announces Receipt of Complete Response Letter from FDA for Corneal Cross-Linking NDA

Avedro, Inc., a Boston-based ophthalmic pharmaceutical and medical device company, announces that it received a complete response letter from the FDA regarding the New Drug Application (NDA) for their riboflavin ophthalmic solution/KXL System for corneal cross-linking. The agency identified a small number of areas of the application concerning the device which require additional information, none of which pertain to the clinical study safety or efficacy data presented in the NDA.

“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,” said David Muller, CEO for Avedro. “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.”

On 24 February 2015, the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee had voted in support of approval of the NDA for the treatment of progressive keratoconus or corneal ectasia following refractive surgery, both of which are orphan indications. Keratoconus is a potentially blinding disease, for which limited therapeutic treatment is available in the US. Recently, the Eye Bank Association of America noted that over 6800 corneal transplants were performed annually in patients diagnosed with keratoconus. Corneal ectasia is a rare outcome of refractive surgery, such as LASIK or PRK, and is a progressive condition that can lead to vision loss. If approved, the riboflavin ophthalmic solution/KXL System would be the first FDA approved therapeutic treatment for these orphan indications.