Avedro announced that it has resubmitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for riboflavin ophthalmic solution/KXL System for the treatment of progressive keratoconus or corneal ectasia following refractive surgery.
In March, the FDA had issued a Complete Response Letter in response to the NDA submission for riboflavin ophthalmic solution/KXY system. The FDA identified a number of areas of the application that require additional information.
The proposed indications were both granted Orphan Drug designation by the FDA in 2011. 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.
For more information call (781) 768-3400 or visit Avedro.com.