Regenerx Biopharma (RGRX) JV Commences Second Dry Eye Syndrome-Focused Phase 3 Trial

September 30, 2016 10:21 AM EDT
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RegeneRx Biopharmaceuticals, Inc. (OTC: RGRX) announced that ReGenTree, RegeneRx's U.S. joint venture with GtreeBNT, initiated its second Phase 3 trial for Dry Eye Syndrome this month and will begin patient enrollment shortly. The double-masked, placebo-controlled trial is expected to enroll approximately 500 patients who will be treated for 28 days with RGN-259, the Company's proprietary, preservative-free eye drops. The clinical trial is expected to be completed during the second half of 2017 with the results expected to be reported during that period as well.

The trial's primary endpoints are intended to replicate and confirm results from ReGenTree's previous Phase 2b/3 trial showing, (1) a statistically significant improvement in inferior corneal staining and (2) a statistically significant improvement in ocular discomfort, when subjects are challenged in a controlled adverse environment (CAE™) at the end of treatment. The FDA has reviewed and agreed to the study protocol and overall clinical plan for RGN-259 for the treatment of Dry Eye Syndrome.

Previous clinical trials have shown that RGN-259 is safe and well-tolerated and without any side effects observed with other dry eye modalities.

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