RegeneRx Announces Positive Phase III Results for RGN-259 in Dry Eye

November 17, 2017: By Jon Swedien

RegeneRx Biopharmaceuticals’ proposed dry eye treatment, RGN-259, showed statistically significant improvement over placebo in its ARISE-2 Phase III clinical study, the Rockville, Maryland company reported Oct. 31.

RGN-259, a Thymosin beta 4 (Tβ4)-based sterile and preservative-free eye drop, is as a novel treatment candidate for dry eye and neurotrophic keratitis (NK), and other corneal diseases, RegeneRx said.

The ARISE-2 trial was sponsored by ReGenTree, a US joint venture company owned by GtreeBNT, a bio venture company in South Korea, and RegeneRx.

The trial investigated the safety and efficacy of RGN-259 for the treatment of the signs and symptoms of dry eye syndrome in 601 patients.

RGN-259 (0.1%) demonstrated a number of statistically significant improvements in both signs and symptoms, while showing excellent safety, comfort, and tolerability profiles, ReGenTree said.

For example, the RGN-259-treated group saw a statistically significant reduction in ocular discomfort at day 15 compared with placebo (p=0.0149) in a change from baseline, ReGenTree said.

ReGenTree president and CEO Won S. Yang said the company plans to meet with the US FDA to discuss the ARISE-2 findings.

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