RegeneRx Joint Venture Expects to Complete Phase 3 Dry Eye Trial in November 2020

RegeneRx Biopharmaceuticals announced that its US joint venture partner, GtreeBNT, is accelerating the ARISE-3 phase 3 clinical trial for dry eye syndrome. According to GtreeBNT, the ARISE-3 trial was delayed a few months due to COVID-19; however, they have recently secured four additional clinical sites, increasing the total to 19 sites, and they anticipate completion of enrollment and treatment of all 700 patients in November 2020. The trial is being sponsored by ReGenTree, a U.S. joint venture owned by RegeneRx and GtreeBNT.

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 the 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. 

Recently, GtreeBNT announced that it has secured additional major 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.