CXL system gains additional indication

Avedro’s KXL syst and 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 for the treatment of progressive keratoconus in April this year.The products have now been FDA approved for use in CXL for the treatment of corneal ectasia following refractive surgery, marking the products’ second indication. This much anticipated availability of an FDA-approved CXL therapy fills an unmet need in our ability to best treat our patients, Avedro medical monitor Dr Peter Hersh said. 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 data from three clinical trials evaluating the use of the KXL syst in patients with corneal ectasia following refractive surgery.Study one enrolled 58 patients with progressive keratoconus and 49 patients with corneal ectasia following refractive surgery; study two enrolled 147 patients with progressive keratoconus; and study three enrolled 130 patients with corneal ectasia following refractive surgery.At 12 months, treated eyes had a mean reduction in maximum keratometry of 1D in study one and 0.5D in study three compared with a mean increase of 1D in study one and 0.5D in study three in ‘sham-controlled’ eyes.Adverse effects for the corneal ecstasia patients who participated in the studies included corneal opacity, corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity and blurred vision.