Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Avedro, a US based pharmaceutical and medical device company, has received the US Food and Drug Administration (FDA) orphan drug status for VibeX (0.1.% riboflavin ophthalmic solution) to be used with its KXL System (UVA irradiation) for Corneal Cross-linking as a treatment for Keratoconus.
Subscribe to our email newsletter
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.