Avedro’s KXL, VibeX and Keraflex are CE marked and are commercially available outside of the US.
Currently, the company has filed an additional application for orphan drug designation for cross-linking for the treatment of corneal ectasia following refractive surgery.
Avedro CEO David Muller said this orphan drug designation, along with the encouraging clinical results from our Phase III keratoconus study, is another important step in bringing this technology to patients in the US.
"We look forward to working with FDA as we progress towards an NDA submission in the very near future," Muller said.