The US Food and Drug Administration (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.
Avedro CEO David Muller said that 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.
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Avedro has submitted an additional application for orphan drug designation for cross-linking for the treatment of corneal ectasia following refractive surgery.
