ReGenTree has begun a phase 3 clinical trial of RGN-259 eye drops for the treatment of dry eye syndrome, the company announced in a press release.
The double-masked, placebo-controlled, randomized ARISE-3 trial will compare the safety and efficacy of RGN-259 0.1% compared with placebo in the treatment of signs and symptoms of dry eye. It will include 700 patients at 15 U.S. sites.
RGN-259, which the company says has “wide-ranging protective, repair and regenerative activities,” includes the active small protein thymosin beta 4, which is in naturally occurring tears.
ReGenTree is a joint venture company owned by GtreeBNT and RegeneRx Biopharmaceuticals. It was formed specifically to develop RGN-259.