NDA Submitted for Vibex for Keratoconus and Corneal Ectasia
Avedro announced that it has submitted a New Drug Application (NDA) to the FDA for VibeX (riboflavin ophthalmic solution)/KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery. In 2011, the VibeX/KXL System was granted orphan designation by the FDA for this indication.
VibeX is Avedro's proprietary riboflavin (vitamin B2) used in conjunction with Avedro's KXL System. VibeX is topically applied to the cornea after epithelium removal and allowed to diffuse into the corneal stroma. UV light from the KXL system is applied to the eye which activates the VibeX in the stroma resulting in cornea strengthening.
For more information, call (781) 768-3400 or visit www.avedro.com.