Avedro uses noninvasive strengthening of the cornea with topical drops and photoactivation without surgery or implants to reshape the cornea through cross-linking. The two major avenues for Avedro’s products are corneal disease (keratoconus) and refractive correction. Currently, the Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran solution), Photrexa (riboflavin 5’-phosphate ophthalmic solution), and the KXL system are the only FDA-approved treatments for progressive keratoconus and corneal ectasia following refractive surgery. As of October 2017, more than 10,000 commercial cases had been performed.
Earlier this year, the company decided to concentrate on getting reimbursement for the procedure from the various insurance payers. As of October 2017, there are 28 carriers that reimburse and more than 85 million covered lives. At the ESCRS meeting in October, Avedro launched its Mosaic platform that incorporates topography for customized and personalized treatment, an eye tracker for better alignment, and supplemental oxygen for improved efficacy. Customized cross-linking involves treating the weakest point of the cornea on the apex. Three studies in three different countries confirmed that a customized approach was more efficacious with better flattening when compared with traditional cross-linking. The company is also expanding its range into the low myopia (–1.0 D to –1.25 D) market; in the PiXL for myopia studies, it was shown that central flattening can improve distance vision. The PiXL for presbyopia where cross-linking was done on the mid-periphery showed correction of up to +1.25 D. US Phase II/III trials are planned for next year.
Avedro plans to conduct an Epi-On PiXL study for refractive error correction in the US next year, and has ongoing studies on the optimization of CuRV for keratoconus, PiXL for refractive errors, and Epi-On KXL with supplemental oxygen for keratoconus.