Avedro Release: First FDA Approved Cross-Linking Procedures Are Performed On Patients In The U.S. With Progressive Keratoconus

WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc., an ophthalmic pharmaceutical and medical device company, is now shipping Photrexa Viscous and Photrexa, the drugs used in corneal cross-linking procedures with the KXL System. On April 15, 2016, Avedro 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 progressive keratoconus. Subsequently on July 15, 2016, the company received U.S. FDA approval for the products’ second indication—for the treatment of corneal ectasia following refractive surgery.

“Avedro’s product launch has been highly anticipated by the keratoconus community as patients can now receive the only FDA-approved cross-linking treatment available in the U.S.”

“This is an exciting time in ophthalmology,” said Reza Zadno, PhD, recently appointed CEO for Avedro. “We are proud to announce that FDA approved cross-linking treatments are now a reality, and our Photrexa drug products are now available. Clinicians have already started to treat their patients in the U.S. who are suffering from progressive keratoconus or corneal ectasia.”

Rajesh Rajpal, MD, Chief Medical Officer for Avedro and a practicing cornea specialist at See Clearly Vision Group, added, “We were thrilled to treat our first patients after FDA approval last week in my practice. Avedro shipped the Photrexa products to over 50 locations in the U.S. over the last week, with more shipping each day, and practices are now treating patients. This marks a tremendous milestone and offers new hope to patients in the U.S., to help with their vision challenges and to treat these sight-threatening diseases.”

“Avedro’s product launch has been highly anticipated by the keratoconus community as patients can now receive the only FDA-approved cross-linking treatment available in the U.S.,” said Mary Prudden, Executive Director for the National Keratoconus Foundation. “The timing is ideal as we prepare for the first World Keratoconus Day taking place on November 10th.”

Corneal collagen cross-linking with Avedro’s Photrexa Viscous, Photrexa and the KXL system is the first and only cross-linking therapy approved by the FDA. Patients should consult their ophthalmologist to determine if corneal cross-linking is right for them. Patients and families can locate an ophthalmologist performing this procedure using the “Find a Physician” tool on Avedro’s website.

What are Photrexa Viscous and Photrexa?
PHOTREXA VISCOUS and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.

Important Safety Information
In progressive keratoconus patients, the most common ocular adverse reactions were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision.

In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision.

Ulcerative keratitis can occur, and patients should be monitored for resolution of epithelial defects. It is not known if CXL is safe and effective in pediatric patients below the age of 14 years.

Please see full Prescribing Information by clicking here: http://avedro.com/wp-content/uploads/dlm_uploads/13597/

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

About Keratoconus
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 Americans¹ 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.

About 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.

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’s Photrexa Viscous, Photrexa and KXL products are approved for sale in the United States for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. 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.

¹ National Eye Institute (NEI). Facts About The Cornea and Corneal Disease. http://www.nei.nih.gov/health/cornealdisease/#12