WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc. today announced that it has reached a milestone, celebrating 10 years of scientific research, innovation and business. Since its founding in 2008, Avedro has grown from a small R&D company to an internationally recognized ophthalmic pharmaceutical and medical device company and the world leader in corneal remodeling.
“Avedro’s 10-year journey began with the exploration of using microwave technology to reshape the cornea,” said Reza Zadno, PhD, CEO of Avedro. “The company recognized, very early on, the benefits of cross-linking in shaping and stabilizing the cornea and shifted focus to this approach. Our continued investment, innovation and perseverance have resulted in receiving the first and only FDA approval in the U.S. for the treatment of progressive keratoconus as an orphan indication. Additionally, our research outside the U.S. has shown very promising clinical results in multiple refractive applications.”
Important highlights include:
- The introduction of a therapy and standard of care for patients with progressive keratoconus: Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution), Photrexa® (riboflavin 5’-phosphate ophthalmic solution), and KXL® System epi-off corneal cross-linking treatment, which was FDA approved and launched in the U.S. in 2016.
- To date, approximately 13,000 corneas with progressive keratoconus or corneal ectasia following refractive surgery have been treated in the U.S.
- In collaboration with physicians, specialty societies, and patient advocacy organizations, Avedro continues to make strides in securing coverage and facilitating reimbursement of FDA-approved corneal cross-linking. More than 30 insurance carriers now cover the treatment, up from three at the beginning of 2017.
- A continued commitment to rigorous, controlled studies to demonstrate the safety and efficacy of cross-linking, with ongoing development of next-generation procedures to treat keratoconus, including epi-on accelerated cross-linking, CuRV (customized cross-linking), and PiXL (cross-linking for refractive applications) in Europe and Asia.
- Avedro has accumulated significant experience, expertise and clinical data, leading to more than 90 patents issued or pending around the world and 65 company citations in peer-reviewed articles on the topic of corneal cross-linking.
- The development of a state-of-the-art, commercial scale manufacturing facility to support the global supply chain utilizing 5S, 6 Sigma, and Lean methodologies throughout its operations, and, most recently, the implementation of a gold-standard Electronic Production Records system allowing for substantial efficiency, quality, and compliance improvements in all manufacturing facilities and production lines.
Dr. Zadno added, “Since Avedro’s inception, our mission has been consistent—to non-invasively reshape and stabilize the cornea. We’ve demonstrated this and our long-term commitment to patients and practices through the development and launch of our FDA approved cross-linking treatment and through our continued investment in research in next-generation, breakthrough procedures that will provide value to physicians and dramatically improve patients’ lives. Avedro will continue to be a pioneer in the field of corneal remodeling and will continue advancing science and clinical research to bring better solutions to patients around the world.”
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 were 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.