Avedro Inc. won orphan drug status for a solution used with its KXL System to treat a cornea disease called keratoconus, setting the Waltham, Mass.-based company up for 7 years of exclusive rights to the U.S. market if the technology proves out.
The federal watchdog agency deemed Avedro’s VibeX, a 0.1 percent riboflavin ophthalmic solution, as an orphan drug. The ophthalmic solution is used with the company’s UVA radiation system to treat keratoconus, a degenerative disease that accounts for the majority of corneal transplants in the U.S.
Orphan drug status means Avedro will have the exclusive right to market the product for 7 years if the FDA winds up giving it the green light. The program is designed to promote the development of treatments for diseases that affect less than 200,000 people in the States.
“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 U.S.,” Avedro CEO David Muller said in prepared remarks. , CEO of Avedro. “We look forward to working with FDA as we progress towards an NDA submission in the very near future.”
Avedro said it’s also seeking orphan status for another one of its products, cross-linking for the treatment of corneal ectasia following refractive surgery.