NDA submitted for corneal crosslinking

Waltham, MA-Avedro Inc. has submitted a new drug application (NDA) to the FDA for its riboflavin ophthalmic solution used with its ultraviolet irradiation system (VibeX/KXL) for the treatment of keratoconus and corneal ectasia following refractive surgery.

“We are pleased to have submitted our positive results from the first multi-site U.S. clinical studies on corneal collagen crosslinking to the FDA,” said David Muller, PhD, chief executive officer of Avedro. “The [riboflavin ophthalmic solution/ultraviolet irradiation system] NDA submission represents an important milestone toward making crosslinking available to patients suffering from keratoconus and post-LASIK ectasia in the United States.”

Peter Hersh, MD, medical monitor and director of the Cornea and Laser Eye Institute in Teaneck, NJ, said, “The ophthalmology community is now looking forward to the possibility of offering crosslinking to keratoconus and corneal ectasia patients in the near future, addressing a significant unmet medical need. Currently, there are limited treatment options for decreasing the natural progression of keratoconus and ectasia. Crosslinking has the promise of stabilizing these progressive corneal disorders and maintaining patients’ visual function over time.”

The FDA granted the riboflavin ophthalmic solution/ultraviolet irradiation system orphan designation in 2011 for the treatment of keratoconus and corneal ectasia following refractive surgery. The system received CE mark approval in 2010, and has been commercially available internationally since that approval.

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