WALTHAM, Mass.--(BUSINESS WIRE)--Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company is pleased to announce that it has resubmitted its New Drug Application (NDA) for riboflavin ophthalmic solution/KXL® System to the U.S. Food and Drug Administration (FDA), which is a key milestone in the drug approval process. Avedro anticipates an application action date (PDUFA) in April 2016. If approved, the NDA would be the first FDA approved therapeutic treatment for progressive keratoconus and corneal ectasia following refractive surgery.
In February 2015, the FDA Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee voted in support of approval of the NDA for both proposed indications. Subsequently, in March 2015, the FDA issued a second complete response letter asking questions regarding the design of the company’s KXL device, and its equivalence to the clinical study device.
“We have been working closely with the FDA and are pleased that we have been able to successfully complete the additional testing and analysis required to address the questions raised about the equivalence of the KXL device,” said David Muller, PhD, CEO of Avedro. “Treatment for keratoconus and corneal ectasia remains a significant unmet need with thousands of keratoconus patients undergoing corneal transplants every year. An approval in the US would be an important step in caring for these patients, who are living with a sight threatening disease.”
Keratoconus is a potentially blinding disease, for which no 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. 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. Both indications were granted orphan status by the FDA in 2011.
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 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.
