WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc., a Boston-based ophthalmic pharmaceutical and medical device company, announces that it received a complete response letter from the U.S. Food and Drug Administration (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, PhD, 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 February 24, 2015, the U.S. Food and Drug Administration (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 U.S. Recently, the Eye Bank Association of America noted that over 6,800 corneal transplants were performed annually in patients diagnosed with keratoconus.1 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.
About Avedro, Inc.
Avedro is a privately held pharmaceutical and medical device company advancing the science and technology of corneal cross linking and refractive correction.
Avedro distributes its products in various countries outside of the United States through a network of ophthalmic medical device distributors. Avedro’s CE Marked products include capital equipment such as the UV-X devices, the KXL® and KXL II™ Systems, and related proprietary pharmaceuticals such as the VibeX® and MedioCROSS® formulations. These systems and products are used in a variety of treatments including accelerated cross linking for keratoconus, Lasik Xtra® and PiXL™. Avedro’s KXL System and pharmaceuticals are being used in an open-label study involving 83 KXL Systems placed in U.S. clinical sites. Avedro products are not approved for sale in the United States.
1 Eye Bank Association of America. (2014). 2013 Eye Banking Statistical Report. Washington, DC.
