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FDA approves Avedro’s cross-linking system for corneal ectasia following refractive surgery
The FDA has approved the KXL system and two photoenhancers for the treatment of corneal ectasia following refractive surgery, according to an Avedro press release.
The KXL system and the two photoenhancers, Photrexa 0.146% (riboflavin 5’-phosphate ophthalmic solution) and Photrexa Viscous 0.146% (riboflavin 5’-phosphate in 20% dextran ophthalmic solution), previously received FDA approval in April for the treatment of progressive keratoconus.
“This much anticipated availability of an FDA-approved corneal collagen cross-linking therapy fills an unmet need in our ability to best treat our patients,” Peter Hersh, MD, Avedro’s medical monitor, said in the release. “This new approval will help to ensure that this important therapy is available to patients who need it.”
The approval was based on the company’s new drug application submission to the FDA, which included three clinical trials evaluating the use of the KXL system in patients with corneal ectasia following refractive surgery.
At 12 months, treated eyes had a mean reduction in maximum keratometry of 1 D in study 1 and 0.5 D in study 3 compared with a mean increase of 1 D in study 1 and 0.5 D in study 3 in sham-controlled eyes.
Adverse events included corneal opacity, corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity and blurred vision.