Neurotrophic keratopathy treatment granted orphan drug status

RegeneRx Biopharmaceuticals announced that its thymosin beta 4 eye drop has received the U.S. FDA’s orphan drug designation to treat neurotrophic keratopathy.

A clinical study found that the preservative-free eyedrop stimulated healing within four to eight weeks in patients with nonhealing corneas for a minimum of six weeks to over a year. Data also indicates that the drug is safe, well-tolerated, and significantly improves patient comfort, according to the company.

The orphan drug designation provides seven years of extended marketing exclusivity, waiver of FDA user fees, tax credits of up to 50 percent for qualified clinical trial expenses, and eligibility for FDA research grants for clinical trials.