FDA grants orphan drug designation for corneal cross-linking treatment for keratoconus

WALTHAM, Mass. — The U.S. Food and Drug Administration has granted orphan drug status to Avedro for a riboflavin ophthalmic solution combined with a corneal cross-linking system in the treatment of keratoconus, the company announced in a news release.

Avedro recently completed phase 3 clinical trials of corneal cross-linking for the treatment of progressive keratoconus and ectasia after LASIK in the U.S., the release said.

"Avedro's effort to make this clinically important treatment available to U.S. patients will be applauded by all U.S. ophthalmologists who today lack any approved therapeutic treatment to halt the progression of keratoconus, a sight-threatening condition," Peter S. Hersh, MD, medical monitor for Avedro's clinical trials and OSN Refractive Surgery Board Member, said in the release.

The FDA's Office of Orphan Products Development grants orphan drug status to promote the development of treatments for rare diseases and disorders that affect fewer than 200,000 patients in the U.S. Orphan drug designation may qualify Avedro for 7 years of U.S. marketing exclusivity of VibeX (0.1.% riboflavin ophthalmic solution) upon regulatory approval, the release said.

Avedro is seeking orphan drug status for cross-linking in the treatment of corneal ectasia after refractive surgery.

The KXL cross-linking system and VibeX have CE mark status and are available outside the U.S.