Avedro, Inc., submitted a new drug application to the FDA for its 0.1% riboflavin ophthalmic solution (VibeX)/KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery, according to a news release. In December, the VibeX/KXL System was granted orphan designation by the FDA for the same indications.
“We requested a priority review on the application based on the fact that there’s no current therapy to address keratoconus or post-LASIK ectasia patients,” David Muller, PhD, CEO of Avedro, said in a phone interview with Cataract & Refractive Surgery Today, “and having the orphan drug designation may help that along, although we certainly can’t opine on how the FDA will manage it. If we’re fortunate enough to get priority review, then the examination cycle as it were, would be 6 months, so that’s what we’re hoping for.”
The application was based on the positive results of a multisite clinical study of more than 500 patients treated for keratoconus and post-LASIK ectasia. If the application is approved, Avedro will be entitled to 7 years of US marketing exclusivity for these indications.
The VibeX/KXL System received the CE Mark in 2010 and has been commercially available internationally since that approval.
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