Avedro 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,” Reza Zadno, PhD, CEO of Avedro, said in a company news release. “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.”