Pharma Focus Asia

RegeneRx's U.S. Joint Venture Initiates Key Phase 3 Dry Eye Clinical Trial with RGN-259

Wednesday, February 13, 2019

RegeneRx Biopharmaceuticals, Inc., a clinical-stage drug development company focused on tissue protection, repair and regeneration, announced today that ReGenTree, LLC, a joint venture between GtreeBNT and RegeneRx, has executed an agreement with Ora, Inc., located in Andover, Massachusetts, for initiation of ARISE-3 to study ReGenTree's new drug, RGN-259, a sterile, preservative-free eye drop for the treatment of dry eye syndrome. ARISE-3 is a randomized double-masked, placebo-controlled phase 3 clinical trial that is based on the results of previous clinical trials, ARISE-1 and ARISE-2.

According to ReGenTree officials, "A total of 700 patients will be enrolled in the trial and we expect the treatment will be completed in the first half of 2020."

"We are pleased that ReGenTree has initiated ARISE-3 and look forward to moving RGN-259 through the FDA regulatory process, via ReGenTree or a partner, and into the market as soon as possible to treat this common disorder," stated J.J. Finkelstein, Chief Executive Officer.

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