Avedro announced that it has resubmitted its New Drug Application (NDA) for riboflavin ophthalmic solution/KXL System to the Food and Drug Administration (FDA) for the treatment for progressive keratoconus and corneal ectasia following refractive surgery.
The NDA resubmission resulted after the issuance of the second Complete Response Letter by the FDA asking questions regarding the design of the company’s KXL device, and its equivalence to the clinical study device.
Avedro anticipates an application action date (PDUFA) in April 2016. If FDA-approved, riboflavin ophthalmic solution/KXL System would be the first therapeutic option for progressive keratoconus, a potentially blinding disease with no available treatment, and corneal ectasia, a rare progressive outcome of refractive surgery, such as LASIK or PRK, that can lead to vision loss.
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