Avedro Announces Its Second FDA Orphan Drug Designation for Corneal Cross-linking

WALTHAM, Mass., Dec 07, 2011 (BUSINESS WIRE) -- Avedro, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the Company's VibeX (riboflavin ophthalmic solution) for use with its KXL System (UVA irradiation) for Corneal Cross-linking to treat corneal ectasia following refractive surgery, such as Lasik and photorefractive keratectomy (PRK). Corneal ectasia is a rare outcome of refractive surgery but is a progressive condition that is difficult to manage. This is the company's second orphan drug designation for VibeX.

"Avedro has yet again hit a major milestone in its efforts to make this clinically important treatment available to US patients," said Dr. Peter Hersh, a leading refractive surgeon and Medical Monitor for Avedro's clinical trials. "US ophthalmologists will be encouraged by this progress, as today they lack any approved therapeutic treatment to halt the progression of ectasia following refractive surgery."

source: Avedro