FDA approves Avedro’s cross-linking system for progressive keratoconus
The FDA has approved the KXL System and two photoenhancers for corneal collagen cross-linking treatment of progressive keratoconus, according to a press release from Avedro.
The photoenhancers are Photrexa 0.146%, a riboflavin 5’-phosphate solution, and Photrexa Viscous 0.146%, a riboflavin 5’-phosphate in 20% dextran ophthalmic solution.
“We plan to begin taking orders for the KXL System immediately and plan to begin shipping our Photrexa products in the next few months as we ramp up our drug manufacturing,” Brian Roberts, chief operating and financial officer for Avedro, said in the release.
The approval was based on data from three prospective, randomized, parallel-group, open-label, placebo-controlled 12-month trials conducted in the U.S. to determine safety and effectiveness, the release said.
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