Last Patient, Last Visit Completed in RegeneRx Phase 3 Dry Eye Clinical Trial

RegeneRx Biopharmaceuticals announced that the final patient in its 700 subject, ARISE-3 phase 3 clinical trial for dry eye syndrome has completed treatment and follow-up.

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, to date, 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.

“We are pleased to report that the ARISE-3 trial has successfully completed treatment and follow-up of the last patient during a very challenging time created by the COVID-19 pandemic. Next steps are to lock the subject database and conduct the appropriate statistical analyses to determine the results of the trial,” J.J. Finkelstein, president and chief executive, said in a company news release.

The ARISE-3 trial is being sponsored by ReGenTree, a U.S. joint venture company owned by RegeneRx and G-treeBNT, a Korean biopharmaceutical company.

This year, 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.