FDA Advisory Committee Recommends Approval For Avedro, Inc.’S Riboflavin Ophthalmic Solutions With UVA Irradiation For Corneal Collagen Cross-Linking To Treat Progressive Keratoconus And Corneal Ectasia

WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc., a Boston-based ophthalmic pharmaceutical and medical device company, announced today that 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 voted in support of approval for 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. The panel voted 10 to 4 in support of approval for progressive keratoconus with 1 abstention and 6 to 4 in support of approval for corneal ectasia following refractive surgery with 4 abstentions and 1 member not voting. The FDA is not required to follow the recommendation of the panel, though it usually considers the recommendation when making its decision on approval of the product.

"We are pleased with the panel recommendation, which represents an important milestone toward making this innovative therapeutic treatment available to patients with either keratoconus or corneal ectasia following refractive surgery,” said David Muller, PhD, President and Chief Executive Officer for Avedro. “We appreciate the opportunity to present our comprehensive findings and look forward to continuing discussions with the FDA as their review of the NDA continues.”

The Avedro NDA submission encompasses data from three prospective, randomized, parallel-group, open-label, placebo-controlled, 12-month trials conducted in the United States to determine the safety and effectiveness of certain riboflavin ophthalmic solutions used in conjunction with UVA irradiation for performing corneal cross-linking in eyes with progressive keratoconus and corneal ectasia following refractive surgery. Avedro’s KXL System, used in combination with riboflavin ophthalmic solutions, received orphan drug designation for both keratoconus and corneal ectasia following refractive surgery, which may provide the Company with up to seven years of market exclusivity for the KXL System and certain riboflavin ophthalmic solutions for those indications, if approved.

The PDUFA goal date for the NDA 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 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.

Contacts

Avedro, Inc.

David Iannetta, 781-768-3400

diannetta@avedro.com

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