Avedro Inc. won an orphan drug designation for a solution used with its KXL irradiation system to treat corneal ectasia following refractive surgery.
The decision sets the Waltham, Mass.-based company up for 7 years of exclusive rights to the U.S. market if the technology pans out.
The VibeX ophthalmic solution is used with the company’s UVA radiation system for corneal cross-linking to treat corneal ectasia following refractive eye surgeries such as Lasik.
This is the second time the federal watchdog agency deemed Avedro’s VibeX, a 0.1 riboflavin ophthalmic solution, as an orphan drug. Avedro first won the label in September to treat a cornea disease called keratoconus.
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 second orphan drug designation, along with the encouraging clinical results from our Phase III post-Lasik ectasia study, is an important commercial milestone and brings us one step closer toward bringing this exciting technology to patients in the US," David Muller, CEO of Avedro said in prepared remarks.
Avedro said it plans to file for approval by the federal watchdog agency in the first quarter of 2012.
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