WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc., a Boston-based ophthalmic pharmaceutical and medical device company, announced today that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee and Ophthalmic Devices Panel of the Medical Devices Advisory Committee will jointly review Avedro’s new drug application (NDA) for riboflavin ophthalmic solutions with UVA irradiation for use in corneal collagen cross linking for the treatment of the conditions underlying progressive keratoconus or corneal ectasia following refractive surgery, on February 24, 2015.
“We believe notification of the FDA advisory committee meeting represents continued progress toward our goal of obtaining U.S. approval for cross linking with our KXL® System to treat patients with either keratoconus or corneal ectasia following refractive surgery,” said David Muller, PhD, President and Chief Executive Officer. “We look forward to discussing the efficacy and safety data included in our submission with the committee and the FDA review team in order to bring our Avedro Cross Linking Platform to the United States, if approved.”
The Avedro NDA submission encompasses data from three prospective, randomized, parallel-group, open-label, sham-controlled, 12-month trials conducted in the United States to determine the safety and effectiveness of riboflavin ophthalmic solutions used in conjunction with UVA irradiation for performing corneal cross linking in eyes with keratoconus and corneal ectasia following refractive surgery. Our KXL System, used in combination with riboflavin ophthalmic solutions, received orphan drug designation for both keratoconus and ectasia following refractive surgery, which may allow us seven years of market exclusivity for our KXL System and certain riboflavin ophthalmic solutions for those indications, if approved.
The PDUFA action date is March 29, 2015.
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 around the world through more than 30 ophthalmic 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. The 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 Phase III US clinical trials involving over 100 US clinical sites. Avedro products are not for sale in the US.
