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Avedro resubmits NDA for KXL system for corneal cross-linking

Issue: November 10, 2015

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Avedro has resubmitted a new drug application for riboflavin ophthalmic solution/KXL system for corneal cross-linking to the FDA, according to a press release.

In March, the FDA issued a second complete response letter asking questions about the design of the KXL system and its equivalence to the clinical study device.

The company anticipates an application action date in April 2016, the release said.

“We have been working closely with the FDA and are pleased that we have been able to successfully complete the additional testing and analysis required to address the questions raised about the equivalence of the KXL device,” David Muller, PhD, CEO of Avedro, said in the release.

If the system were approved, it would be the first FDA-approved therapeutic treatment for progressive keratoconus and corneal ectasia after refractive surgery.