RegeneRx Joint Venture Enrolls Last Subject in Phase 3 Dry Eye Trial

RegeneRx Biopharmaceuticals announced that its joint venture, ReGenTree LLC, has enrolled the last of 700 subjects in the ARISE-3 phase 3 clinical trial for dry eye syndrome. Completion of treatment and follow-up for the last subject is anticipated to be by the end of November 2020.  

ReGenTree is a U.S. joint venture company owned by RegeneRx and GtreeBNT, a Korean biopharmaceutical company.

ARISE-3 is designed to assess the safety and efficacy of 0.1% RGN-259 eye drops compared to placebo after 2 weeks of administration in 700 subjects with dry eye syndrome. RGN-259 is a proprietary eye drop that has demonstrated fast onset efficacy in two previous phase 3 clinical trials, “ARISE-1” and “ARISE-2,” is safe and well-tolerated, and has not shown any adverse side effects such as eye irritation, stinging, visual disturbance, etc., unlike currently approved products. 

This year, GtreeBNT announced that it has secured additional intellectual property rights, including patents related to composition, formulation, and manufacturing of RGN-259 eye drops, and that RGN-259 has recently been reclassified as a biologic requiring a Biologics License Application (BLA), rather than an new drug application (NDA), conferring 12 years of market exclusivity when the product is approved by FDA.