RegeneRx enrolls first patient in RegeneRx JV phase 3 dry eye trial
RegeneRx Biopharmaceuticals announced that the first patient has been enrolled in ARISE-3, a phase 3 clinical trial sponsored by ReGenTree, a U.S. joint venture between RegeneRx and GtreeBNT. The clinical trial will evaluate RGN-259, a sterile, preservative-free eye drop in 700 patients with dry eye syndrome at approximately fifteen nationwide clinical sites across the U.S., including hospitals and clinics specializing in ophthalmology, comparing the drug candidate to placebo. Completion is expected during mid-2020. Dry eye syndrome is a common condition affecting millions of people throughout the world. DES is a disorder where loss of homeostasis of the tear film results in pain, itching, blurry vision, and dryness, among other symptoms. RGN-259 eye drops contain an active small protein, thymosin beta 4, which is naturally occurring in tears and other body fluids. RGN-259 eye drops have demonstrated wide-ranging and multifunctional activities. Such activities underlie the efficacy of RGN-259 eye drops seen to date in alleviating both the signs and symptoms of dry eye. Moreover, RGN-259 eye drops are safe and well-tolerated by patients, and in both ARISE-1 and ARISE-2, patients reported minimal ocular discomfort similar to that of the placebo.