News
19 Sep 2011
FDA Grants Orphan Drug Designation to Avedro's VibeX
The FDA has granted orphan drug designation to Avedro's VibeX solution for use with its KXL System for corneal cross-linking to treat keratoconus.
The US FDA has granted orphan drug designation to Avedro's VibeX (0.1.% riboflavin ophthalmic solution) for use with its KXL System (UVA irradiation) for corneal cross-linking to treat keratoconus.
The orphan drug designation, along with the encouraging clinical results from the Phase III keratoconus study, is an important step in bringing the technology to patients in the US, according to Avedro CEO David Muller.
Avedro has submitted an additional application for orphan drug designation for cross-linking for the treatment of corneal ectasia following refractive surgery.
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