UPDATE -- Avedro Reaches Reimbursement Milestone for Its FDA-Approved Procedure for Progressive Keratoconus
05 Avril 2019 - 3:00PM
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.
About Avedro, Inc.
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
INDICATIONSPhotrexa® 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 USEThe 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 PRECAUTIONSUlcerative keratitis can occur. Patients
should be monitored for resolution of epithelial defects.
ADVERSE REACTIONSIn 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 |
|
|
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