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Avedro has resubmitted its New Drug Application (NDA) for riboflavin ophthalmic solution/KXL System to the FDA.
According to the company, Avedro anticipates an application action date in March 2015.
The resubmission is a comprehensive reply to questions and requests from the FDA’s March complete response letter.
“We have been working closely with the FDA to address the issues raised in the complete response letter,” said David Muller, PhD, chief executive officer of Avedro. “We are very pleased to be able to resubmit the NDA and answer the questions that were posed to the company.”
The proposed indications of treatment of progressive keratoconus or corneal ectasia following refractive surgery were both granted orphan drug status by the FDA in 2011. If approved, the ophthalmic solution would be the first FDA approved therapeutic treatment for these orphan indications, and entitle Avedro to 7 years of U.S. market exclusivity, the company said.
“U.S. ophthalmic surgeons are pleased to hear of this next step in the process with the FDA,” said Peter Hersh, MD, Hersh Vision Group, NJ, and Avedro medical monitor. “Cross-linking represents an important treatment option that addresses an unmet medical need. U.S. patients and their ophthalmologists eagerly await the availability of corneal cross-linking.”
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