Earlier today, ophthalmic pharmaceutical and medical device company Avedro, Inc., received approval from the US Food and Drug Administration (FDA) for Photrexa® Viscous, Photrexa® and the KXL® System, reportedly making them the first and only FDA-approved therapeutic treatment for progressive keratoconus.
According to Avedro, Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146% and Photrexa (riboflavin 5’-phosphate ophthalmic solution) 0.146% are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus. The FDA approval was reportedly based on Avedro's NDA submission that included data from three 12-month trials performed in the US to determine the safety and efficacy of Photrexa Viscous and Photrexa when used for performing corneal cross-linking in eyes with progressive keratoconus.
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