Avedro Receives FDA Approval for Treatment of Progressive Keratoconus

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. 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 United States, affecting approximately one in every 2,000 Americans¹ or approximately 170,000 people in the United States. 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.”

“I applaud Avedro’s efforts to make this clinically important treatment available to U.S. patients,” said Peter Hersh, M.D., of The Cornea and Laser Eye Institute – CLEI Center for Keratoconus (Teaneck, N.J.), and the clinical study medical monitor. “In the studies, treated eyes showed improvement in K_max at 12 months, while in untreated eyes K_max continued to worsen. The Photrexa formulations and the KXL system represent an invaluable new treatment option for corneal surgeons in the treatment of keratoconus patients.”

Rajesh Rajpal, MD, Chief Medical Officer for Avedro added, “Avedro and I look forward to working with U.S. ophthalmologists to raise awareness of our new FDA-approved treatment for progressive keratoconus. Avedro is hosting an evening event during the ASCRS meeting in New Orleans in early May.  This will be an opportunity for US ophthalmologists to learn what approval of Photrexa Viscous, Photrexa and the KXL System means to their keratoconic patients.”

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.

The approval was based on Avedro’s NDA submission which 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 Photrexa Viscous and Photrexa when used for performing corneal cross-linking in eyes with progressive keratoconus.  These studies included Study 1, which enrolled 58 patients with progressive keratoconus, and Study 2, which enrolled 147 patients with progressive keratoconus.  In each study, patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye.

The cross-linked eyes showed increasing improvement in K_max from Month three through Month 12. K_max is defined as the maximum corneal curvature and measured in diopters (D). Progressive keratoconus patients had an average K_max reduction of 1.4 D in Study 1 and 1.7 D in Study 2 at Month 12 in the cross-linked eyes, while the untreated eyes had an average increase of 0.5 D in Study 1 and 0.6 D in Study 2 at Month 12; the difference (95 percent CI) between the cross-linked and untreated groups in the mean change from baseline K_max was -1.9 (-3.4, -0.3) D in Study 1 and -2.3 (-3.5, -1.0) D in Study 2.

• Ulcerative keratitis can occur, and patients should be monitored for resolution of epithelial defects.
• In clinical studies, the most common ocular adverse reactions in any cross-linked eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.

Avedro is a privately held pharmaceutical and medical device company advancing the science and technology of corneal cross-linking and refractive correction. Avedro’s Photrexa Viscous, Photrexa and KXL products are approved for sale in the United States for the treatment of progressive keratoconus. Avedro’s products sold outside of the United States include capital equipment such as the UV-X devices, the KXL and Mosaic Systems, and related proprietary pharmaceuticals such as the VibeX and MedioCROSS formulations. Avedro distributes its products in countries outside of the United States through a network of ophthalmic medical device distributors.