Just about two weeks after getting Food and Drug Administration (FDA) clearance for its corneal crosslinking platform, Avedro Chief Medical Officer Rajesh K. Raipal, MD, outlined the company’s next steps to advance its position in the crosslinking space during the Ophthalmology Innovations Showcase at OIS@ASCRS 2016.
The FDA approved three components of the crosslinking platform: Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146%: Photrexa (riboflavin 5’-phosphate ophthalmic solution) 0.146%; and the KXL system. Photrexa Viscous and Photrexa are photoenhancers indicated for use with the KXL system for the treatment of progressive keratoconus.
Since closing a $32 million round of financing last year, Avedro has been building its sales and service force in the US to coincide with its launch of Photrexa and KXL system at ASCRS, Dr. Raipal said. “We will be shipping product within the next few months,” he said.
“Turning to the future, I think it’s best to think of crosslinking as a platform that can have multiple applications, and perhaps most importantly in the refractive surgery space as a noninvasive procedure,” he said. He noted the Mosaic system received the CE mark last year for the customized treatment of low-level myopia, and shared early results from two studies and summarized to international studies that showed favorable results in correcting myopia with the platform.
“We have multiple ongoing transepithelial studies outside the US that are allowing us to refine nomograms and develop algorithms for the appropriate levels of treatment, but also to study the effect of supplemental oxygen that may allow us to treat higher levels of correction,” he said.
Rajesh K. Rajpal, MD
Raj Rajpal, MD is a board certified ophthalmologist who has established an internationally recognized reputation as an expert in the fields of corneal, cataract, and refractive surgery.