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Avedro Announces Resubmission of New Drug Application to FDA for Corneal Cross-Linking
Oct 07, 2014 | Business Wire
Avedro, Inc., a Boston-based ophthalmic medical device and pharmaceutical company [founded by Dartmouth engineering professor Stuart Trembly], announced that it resubmitted its New Drug Application (NDA) for riboflavin ophthalmic solution/KXL® System to the U.S. Food and Drug Administration (FDA). 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.
The proposed indications of treatment of progressive keratoconus or corneal ectasia following refractive surgery were both granted orphan status by the FDA in 2011. Patients with these sight threatening conditions may require corneal transplant surgery. If approved, riboflavin ophthalmic solution/KXL System would be the first FDA approved therapeutic treatment for these orphan indications, and entitle Avedro to seven years of US market exclusivity.
“US ophthalmic surgeons are pleased to hear of this next step in the process with the FDA,” said Peter Hersh, MD, Hersh Vision Group, Teaneck, NJ and Avedro Medical Monitor. “Cross-linking represents an important treatment option that addresses an unmet medical need. US patients and their ophthalmologists eagerly await the availability of corneal cross-linking.”
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