Avedro refiles KXL System for Keratoconus with FDA - Avedro
Avedro has resubmitted its New Drug Application (NDA) for KXL System (riboflavin ophthalmic solution) to the FDA, for the proposed indications of treatment of progressive Keratoconus or corneal ectasia following refractive surgery. Avedro anticipates an application action date (PDUFA) in March 2015. This resubmission is a comprehensive reply to questions and requests from the March 2014 complete response letter. If approved, KXL System would be the first FDA approved therapeutic treatment for these orphan indications, and entitle Avedro to seven years of US market exclusivity.
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