Avedro Inc. announced that it has received a Complete Response Letter from the FDA regarding the New Drug Application (NDA) for its riboflavin ophthalmic solution/KXL System. In the complete response letter, the FDA identified a number of areas of the application that require additional information.
Keratoconus is a potentially blinding disease, for which limited therapeutic treatment is available in the U.S. Corneal ectasia is a rare outcome of refractive surgery (eg, LASIK) and is a progressive condition that is difficult to manage. Patients with these sight-threatening conditions may require corneal transplant surgery.
If approved, the riboflavin ophthalmic solution/KXL System would be the first FDA approved therapeutic treatment for these orphan indications. Avedro’s KXL System and single dose pharmaceutical products are currently being used in three Phase 3 clinical trials.
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