Avedro Receives FDA Approval for Photrexa® Viscous, Photrexa® and the KXL® System for Corneal Cross-Linking

Avedro

April 18, 2016

Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146%, Photrexa (riboflavin 5’-phosphate ophthalmic solution) 0.146%, and the KXL system are the first and only FDA-approved therapeutic treatment for progressive keratoconus

Stuart Trembly
Prof. Stuart Trembly
, founder of Avedro

Avedro, Inc., an ophthalmic pharmaceutical and medical device company, has received approval from the US Food and Drug Administration (FDA) for Photrexa Viscous, Photrexa and the KXL System. Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus. Avedro’s Photrexa Viscous, Photrexa and the KXL System represent a first-in-class therapeutic treatment for this sight threatening indication.

“This approval marks a tremendous milestone for the treatment of progressive keratoconus,” said Brian Roberts, Chief Operating and Financial Officer for Avedro. “We’re excited to provide ophthalmologists in the United States with these tools to treat this orphan disease. We thank the FDA for their diligent efforts as we worked towards approval. We plan to begin taking orders for the KXL System immediately, and plan to begin shipping our Photrexa products in the next few months as we ramp up our drug manufacturing.”

Keratoconus is a progressive thinning and distortion of the cornea. It is the most common corneal dystrophy in the US, affecting approximately one in every 2,000 Americans or approximately 170,000 people in the US. Keratoconus causes the cornea to bulge from its normal symmetric domelike smooth optical shape, creating an abnormal curvature that changes the cornea’s optics, producing blurred and distorted vision that is difficult to correct with spectacle lenses. This progressive thinning and weakening can result in significant visual loss and may lead to corneal transplants.

“This FDA approval has been highly anticipated by the keratoconus community,” said Mary Prudden, Executive Director for the National Keratoconus Foundation. “Corneal cross-linking provides patients a much-needed option to treat this debilitating disease. Patients suffering from progressive keratoconus can now receive a therapeutic treatment that has been rigorously tested and approved.”

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