WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc., today marked the one year anniversary of the U.S. commercial availability of Photrexa Viscous® (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution), the drugs used in corneal cross-linking with the KXL® System, for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. In that period, Avedro estimates that 10,000 procedures have been completed at more than 250 sites.
Avedro also reported significant progress in its efforts to secure insurance coverage of its cross-linking procedure, supported by the recent launch of the ARCH Program (Avedro Reimbursement Customer Hub) to expand commercial coverage and to assist with the commercial payer appeals process. Thus far in 2017, insurance coverage for the FDA-approved cross-linking treatment has grown from three carriers to more than twenty-five, demonstrating an encouraging trend in coverage. These commercial carriers cover approximately 85 million insured Americans.1
“I’m pleased to report that demand for our cross-linking procedure has been strong and insurance coverage is increasing. The combined efforts of physicians, specialty societies, patient advocacy organizations, and Avedro are accelerating expanded coverage for patients and reimbursement,” said Reza Zadno, PhD, CEO of Avedro. “This combined effort continues with commercial insurers that have yet to establish positive reimbursement policies. Avedro is commited to ensuring that all patients who require cross-linking have access to treatment for this sight-threatening orphan disease.”
“Both our patients and our practice have truly benefited from the availability of Avedro’s corneal cross-linking procedure and the support of ARCH, the company’s reimbursement program,” said Dr. Eric D. Donnenfeld, a board certified ophthalmologist and founding partner of Ophthalmic Consultants of Long Island (OCLI). “We have seen an increasing number of commercial payers covering the procedure, and we have the tools and support we need to work through the process of securing insurance coverage and payment. I encourage all physicians to take advantage of the ARCH program. Only through a unified effort will we continue to increase patient access for this one-time therapy.”
Avedro continues to make a significant investment in the next generation of cross-linking procedures and technologies that will protect and improve vision. Presently, the company is finalizing plans for a U.S. Phase 3 epi-on cross-linking study for the treatment of progressive keratoconus. In addition, there are several clinical development programs active in Europe that will further the study of non-invasive treatments. We remain fully committed to developing breakthrough cross-linking products that not only dramatically improve the lives of patients with keratoconus but also help reduce the need for eyeglasses and contact lenses in an even larger population,” added Dr. Zadno.
Avedro is a privately held pharmaceutical and medical device company and the world leader in corneal remodeling. Avedro’s patented cross-linking technology, consisting of drug formulations and medical devices, are approved for sale in numerous countries around the globe. In the United States the company sells Photrexa Viscous and Photrexa, orphan drugs indicated for the treatment of progressive keratoconus and corneal ectasia following refractive surgery, which was FDA approved in 2016. Avedro continues to develop proprietary corneal cross-linking products for the treatment of keratoconus, a sight-threatening disease, and for refractive correction.
IMPORTANT SAFETY INFORMATION
Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution) are indicated for use with the KXL System in corneal collagen cross-linking (CXL) for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.
LIMITATIONS OF USE
The safety and effectiveness of CXL has not been established in pregnant women, women who are breastfeeding, patients who are less than 14 years of age and patients 65 years of age or older. Photrexa Viscous and Photrexa should be used with the KXL System only.
WARNINGS AND PRECAUTIONS
Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects.
In progressive keratoconus patients, the most common ocular adverse reactions in any CXL treated eye 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.
These are not all of the side effects of Photrexa® Viscous, Photrexa® and the CXL treatment. For more information, see Prescribing Information.
You may report an adverse event to Avedro by calling 1-844-528-3376, Option 1 or you may contact the U.S. Food and Drug Administration (FDA) directly at 1-800-FDA-1088.
1. Total covered lives per AIS’s Directory of Health Plans: 2017.