RegeneRx Biopharmaceuticals announced that GtreeBNT, its Korean partner in the U.S. for development of RGN-259 for the treatment of dry eye disease, issued an update on the U.S. phase 3 clinical trial.
GtreeBNT announced the third phase 3 clinical study [ARISE-3] of RGN-259 [a sterile, preservative-free eye drop], a new drug candidate for the treatment of dry eye syndrome under development by ReGenTree, a U.S. joint venture company between GtreeBNT and RegeneRx Biopharmaceuticals, is progressing without delay. To date, over 350 dry eye patients have been entered into the study.
ARISE-3 will enroll over 700 eye dry patients at 19 eye clinics across the U.S. for two weeks of treatment, comparing the safety and efficacy of RGN-259 against placebo.
ReGenTree completed ARISE-1 in 2016 and ARISE-2 in 2017, which were also U.S. phase 3 studies, enrolling 317 and 601 patients with dry eye, respectively. ReGenTree will consider the possibility of applying for a U.S. NDA based on the degree of statistical significance of dry eye sign and symptom improvement of RGN-259 over placebo. ReGenTree believes that its clinical trials are the most advanced among those products currently undergoing clinical trials in the U.S.
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Dry Eye syndrome is a multi-factorial disease-causing pain, itching, and congestion due to continual damage in the tear film. The global dry eye prescription market size amounts to approximately $3.0 billion, and the market is growing rapidly due to its high prevalence in industrial and densely populated urban regions, but there are only two compounds currently approved for treatment: Restasis by Allergan and Xiidra by Novartis. Because it is believed that ReGenTree's RGN-259 will have a competitive edge over Restasis® and Xiidra®, GlobalData, one of the world's most prestigious pharmaceutical market analysts, announced in its Dry Eye Report published in 2018 that ReGenTree's RGN-259 would rank the first in sales of over $1 billion by 2026.
"We are very pleased that ARISE-3 is enrolling patients on schedule and we eagerly anticipate completion of the phase 3 trial this summer. Completion of ARISE-3 will be a major milestone for us, which we believe, if successful, will significantly enhance the value of RegeneRx. Moreover, we also look forward to the data read-out in the next few months from our other phase 3 clinical trial in patients with chronic neurotrophic keratitis, a highly debilitating lesion in the cornea," said J.J. Finkelstein, president and chief executive officer.