Avedro's VibeX granted orphan drug status as treatment for corneal ectasia following refractive surgery
Monday, December 19 2011 | Comments
The Food and Drug Administration
granted Avedro Inc.
's VibeX (riboflavin) ophthalmic solution an orphan drug designation for use in combination with Avedro's KXL system for corneal crosslinking to treat corneal ectasia following refractive surgery, such as LASIK and photorefractive keratectomy.
Avedro's KXL crosslinking procedure involves the topical application of VibeX to the cornea after epithelium removal. Ultraviolet light from the KXL system is applied to the eye, which activates the VibeX in the stroma, resulting in cornea strengthening.
Corneal ectasia is a rare outcome of refractive surgery but is a difficult-to-manage, progressive condition for which there is no currently approved therapy, Avedro noted.
This is the second orphan drug designation for VibeX. The ophthalmic solution also received orphan drug status in September for the treatment of keratoconus.
Avedro expects to file for FDA approval of VibeX in the first quarter of next year. If VibeX is approved, Avedro will have exclusive marketing rights to the product in the United States.