Avedro announced that the Food and Drug Administration (FDA) has approved Photrexa Viscous (riboflavin 5′-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5′-phosphate), and the KXL System used in corneal collagen cross-linking for the treatment of corneal ectasia following refractive surgery.
Photrexa Viscous and Photrexa, photoenhancers used with the KXL System, were initially approved in April 2016 for the treatment of progressive keratoconus—the first corneal collagen cross-linking therapy to be approved.
The FDA approval for the treatment of corneal ectasia following refractive surgery was based on data from 3 prospective, randomized, parallel-group, open-label, placebo-controlled, 12-month trials. They were sham-controlled for the first 3 months and lasted for 12 months to evaluate safety and efficacy. Study 1 enrolled patients with progressive keratoconus (n=58) and corneal ectasia following refractive surgery (n=49). Study 2 (n=147) enrolled patients with progressive keratoconus. Study 3 (n=130) enrolled patients with corneal ectasia following refractive surgery.
At Month 12, the corneal collagen cross-linking treatment group saw an average Kmax reduction of 1.0 diopter in Study 1 and 0.5 diopter in Study 3, vs. the sham treatment group that saw an increase of 1.0 diopter in Study 1 and 0.5 diopter in Study 3 (treatment difference –2.0 diopters [Study 1]; –1.1 diopters [Study 3]).
Photrexa formulations and the KXL System will be available in early Fall.
Fore more information call (844) 528-3376 or visit Avedro.com.