Avedro Receives Additional Indication for Photrexa® Viscous, Photrexa® and the KXL® System for the Treatment of Corneal Ectasia following Refractive Surgery

Avedro

July 19, 2016

Avedro, Inc., an ophthalmic pharmaceutical and medical device company, has received approval from the U.S. Food and Drug Administration (FDA) for Photrexa Viscous, Photrexa and the KXL System used in corneal collagen cross-linking for the treatment of corneal ectasia following refractive surgery, the products’ second indication.  Avedro’s photoenhancers, Photrexa Viscous and Photrexa, used in conjunction with the KXL System, received an initial indication for the treatment of progressive keratoconus in April 2016, and remains the first and only corneal collagen cross-linking therapy approved in the United States.

“We are pleased to be able to expand the clinical utility of our first-in-class corneal collagen cross-linking technology to another indication,” said Rajesh Rajpal, MD, Chief Medical Officer for Avedro.  “The American Academy of Ophthalmology’s Preferred Practice Pattern for corneal ectasia endorses this approach and emphasizes the importance of treating the condition in its early stages.  Since our initial launch in April, we’ve enjoyed an enthusiastic reception from the ophthalmic community and have been busy filling orders for the KXL System.  With the availability of our Photrexa products in early Fall, clinicians will be able to begin treating their patients with either of these forms of corneal ectasia.”

Corneal ectasia, a non-inflammatory condition marked by progressive corneal steepening and thinning, is a rare but serious complication of vision correction procedures.  The condition can begin within a week of surgery or after several years and is associated with worsening best uncorrected visual acuity, an increase in ocular aberrations, and decreasing best-corrected distance visual acuity.  The incidence of corneal ectasia following refractive surgery is estimated to affect approximately 160,000 patients in the United States, qualifying it as an orphan disease.

“It is significant that Avedro has received this additional indication for corneal collagen cross-linking,” said Peter Hersh, MD of The Cornea and Laser Eye Institute – CLEI Center for Keratoconus, and the Avedro medical monitor. “This much anticipated availability of an FDA-approved corneal collagen cross-linking therapy fills an unmet need in our ability to best treat our patients.  This new approval will help to ensure that this important therapy is available to patients who need it.”

Patients should consult their ophthalmologist to determine if corneal cross-linking is right for them. The Photrexa formulations and the KXL System are expected to be available for qualifying patients through their ophthalmologists before the end of this year.

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