Corneal Crosslinking a Step Closer to FDA Approval
The U.S. Food and Drug Administration (FDA) has granted orphan-drug designation to Avedro, Inc. for VibeX (0.1% riboflavin ophthalmic solution) for use with its CXL System (UVA irradiation) for corneal crosslinking to treat keratoconus. Orphan-drug designation is granted by the FDA Office of Orphan Products Development to promote the development of new therapies for rare diseases and disorders affecting fewer than 200,000 individuals in the United States. Orphan-drug designation may entitle Avedro to seven years of U.S. marketing exclusivity upon regulatory approval.
“The orphan-drug status for riboflavin granted to Avedro from the FDA Office of Orphan Products Development is just a step in the approval of crosslinking for keratoconus. It is a specific designation of the drug, not actual FDA approval of the procedure. The results of the Phase III multicenter clinical trial of crosslinking for keratoconus are very encouraging and continue to be assessed, so progress is steadily continuing” said Dr. Peter Hersh, "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,” said David Muller, CEO of Avedro. “We look forward to working with FDA as we progress towards an NDA submission in the very near future.”
This will definitely help with any insurance claims for the procedure (but will still be a bit of a battle
)Cheers
Chris
