WALTHAM, Mass., April 05, 2019 (GLOBE NEWSWIRE) -- Avedro, Inc ., (Avedro or the company), today announced that four new providers --Providence Health Plan in the Pacific Northwest, Health New England, HealthPartners Minnesota and Public Employees Health Plan (PEHP) in Utah--have issued positive coverage policies for Avedro’s FDA-approved corneal cross-linking procedure, bringing the total number of commercial plans covering the KXL system and its associated Photrexa® drug formulations to over 65. These four plans bring the total number of covered lives in the United States to more than 180 million.
Keratoconus is a debilitating and typically progressive eye disease that can lead to loss of vision and even blindness. Avedro’s KXL system and associated Photrexa ® drug formulations have been approved by the FDA as a one-time treatment that can slow or halt the progression of the disease, potentially eliminating the need for invasive procedures such as corneal transplant.
In addition, Avedro has secured positive coverage from the United States’ largest national commercial payers, including United Healthcare, Anthem Blue Cross Blue Shield, Aetna, Cigna, Humana, and HealthNet. The company estimates that more than 95% of commercially covered lives have access to the Avedro’s potentially sight-saving technology.
“We are very pleased to see that in just one year, access has rapidly and dramatically improved for patients needing therapeutic treatment for progressive keratoconus,” said Reza Zadno, Ph.D., Chief Executive Officer of Avedro. "In addition to securing coverage from our country’s top commercial payers, we’ve received a unique J-code from CMS. This is in large part due to the amazing support and hard work of the societies, doctors and patient advocacy groups who see and hear from patients daily. Avedro will continue to invest in reimbursement services to ensure corneal cross-linking is accessible to patients struggling with progressive keratoconus.”
Patients can find the list of private payer insurance companies providing coverage for corneal cross-linking at LivingwithKeratoconus.com .
Avedro is a leading commercial-stage ophthalmic medical technology company focused on treating corneal ectatic disorders and improving vision to reduce dependency on eyeglasses or contact lenses. Avedro’s proprietary Corneal Remodeling Platform is designed to strengthen, stabilize and reshape the cornea utilizing corneal cross-linking in minimally invasive and non-invasive outpatient procedures to treat corneal ectatic disorders and correct refractive conditions. The Avedro Corneal Remodeling Platform is comprised of Avedro’s KXL and Mosaic systems, each of which delivers ultraviolet A light, and a suite of proprietary single-use riboflavin drug formulations, which, when applied together to the cornea, induce a biochemical reaction called corneal collagen cross-linking.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but are not limited to, statements about the market opportunity for the Avedro Corneal Remodeling Platform and the rate of adoption of FDA approved cross-linking procedures. Words such as “believes,” “expects,” “intends,” “projects,” “anticipates,” and “future” or similar expressions are intended to identify forward-looking statements. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. For a discussion of risks and uncertainties and other important factors, any of which could cause Avedro’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in Avedro’s annual report on Form 10-K filed March 21, 2019 as well as discussions of potential risks, uncertainties and other important factors in Avedro’s subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Avedro undertakes no duty to update this information unless required by law.
IMPORTANT SAFETY INFORMATION
INDICATIONS 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 have 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.
ADVERSE REACTIONS 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.
| Avedro Contact : | Investor Contact: | |
| David Iannetta | Greg Chodaczek or Lynn Lewis | |
| Avedro, Inc. | Phone: 646-924-1769 | |
| (781) 768-3400 | investors@avedro.com | |
| info@avedro.com |
