ReGenTree has initiated a phase 3 clinical trial, called ARISE-3, to evaluate the safety and efficacy of 0.1% RGN-259 eye drops for the treatment of dry eye syndrome.
The company is a US-based joint venture company between GtreeBNT and RegeneRx Biopharmaceuticals.
ARISE-3 is a randomized, double-masked, placebo-controlled trial which will evaluate the 0.1% RGN-259 eye drops in comparison to placebo for the treatment of the signs and also symptoms of dry eye syndrome.
The design of the late-stage clinical trial is based on the data collected from the previously conducted ARISE-1 and ARISE-2 trials.
ReGenTree officials said: “The trial will recruit 700 patients with dry eye syndrome at about fifteen nationwide clinical sites, including hospitals and clinics specialized in ophthalmology, and will be completed in the middle of next year.”
RGN-259 eye drops have thymosin beta 4, an active small protein, which is generated naturally in tears, other body fluids, and cells.
The investigational eye drops are said to have protective, repair, and regenerative activities. ReGenTree claims that such multifunctional activities of the RGN-259 eye drops underlie its efficacy in the signs and symptoms of dry eye.
RGN-259 eye drops were shown to be safe and well-tolerated by patients in the ARISE-1 and ARISE-2 clinical trials. In the two clinical trials, patients showed minimal ocular discomfort on instillation that was identical to that of the placebo.
ReGenTree officials said: “Since RGN-259 eye drops have a much faster onset of efficacy, are well-tolerated, and act by multiple mechanisms of actions that are therapeutically consistent with the underlying causes of multifactorial dry eye disease, the Company believes it can become a leading product in the dry eye treatment market,” said officials at the Company.”