RegeneRx nears eye-drop trials

Ray Frager//October 20, 2014//

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RegeneRx Biopharmaceuticals Inc., of Rockville, may start clinical trials of a treatment for neurotrophic keratopathy, a disease of the cornea, within a year, the company announced. RegeneRx said it met with the Food and Drug Administration in September and as a result of the meeting may begin Phase 3 to evaluate RGN-259 eye drops by mid-2015. The company plans to conduct two trials, each lasting six to nine months, with fewer than 90 patients. Neurotrophic keratopathy is classified as an orphan disease. As defined by the Orphan Drug Act of 1983, that means it affects fewer than 200,000 people in the U.S. If left untreated, the disease can lead to perforation or ulceration in the eye.