Avedro, Inc. announced today that the Company submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for its VibeX™ (riboflavin ophthalmic solution) /KXL™ System for the treatment of keratoconus and corneal ectasia following refractive surgery.
"The ophthalmology community is now looking forward to the possibility of offering cross-linking to keratoconus and corneal ectasia patients in the near future, addressing a significant unmet medical need," said Peter Hersh, MD, Medical Monitor and Director, Cornea and Laser Eye Institute. "Currently, there are limited treatment options for decreasing the natural progression of keratoconus and ectasia. Cross-linking has the promise of stabilizing these progressive corneal disorders and maintaining patients' visual function over time."
In 2011, the VibeX/KXL System was granted orphan designation by the FDA for the treatment of keratoconus and corneal ectasia following refractive surgery. Orphan drug designation is granted by the FDA Office of Orphan Products Development to promote the development of new therapies for rare diseases and disorders affecting fewer than 200,000 individuals in the United States. If approved, orphan drug status will entitle Avedro to seven years of US marketing exclusivity for these indications.
"We are pleased to have submitted our positive results from the first multi-site US clinical studies on corneal collagen cross-linking to the FDA," said David Muller, PhD, CEO of Avedro. "The VibeX/KXL System NDA submission represents an important milestone towards making cross-linking available to patients suffering from keratoconus and post-Lasik ectasia in the US."
The VibeX/KXL System for corneal collagen cross-linking received CE Mark in 2010 and has been commercially available internationally since that approval.
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