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Avedro resubmits NDA for riboflavin, corneal cross-linking system

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Avedro announced the resubmission of its New Drug Application to the U.S. Food and Drug Administration for the riboflavin ophthalmic solution/KXL system.

The company resubmitted its application in response to questions and requests included in the FDA’s complete response letter in March, according to the release.

In 2011, the FDA granted the riboflavin ophthalmic solution/KXL system orphan status for the indications of treating progressive keratoconus or corneal ectasia following refractive surgery.

If approved, the riboflavin ophthalmic solution/KXL system would be the first FDA-approved therapeutic treatment for such indications, entitling Avedro to 7 years of exclusivity in the U.S. market, according to the release.

“We have been closely working with the FDA to address the issues raised in the complete response letter,” David Muller, PhD, CEO of Avedro, said in the release. “We are very pleased to be able to resubmit the NDA and answer the questions that were proposed to the company.”

Avedro anticipates a March 2015 application action date, according to the release.