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ReGenTree Initiates ARISE-3 (Phase 3) Trial for Dry Eye Syndrome

PRINCETON, N.J., May 12, 2019 /PRNewswire/ -- ReGenTree, LLC (the Company), a joint venture company between GtreeBNT and RegeneRx Biopharmaceuticals, announced that it initiated a randomized, double masked, placebo-controlled Phase 3 clinical trial (ARISE-3) for dry eye syndrome on May 10.

The objective of the ARISE-3 study is to compare the safety and efficacy of 0.1% RGN-259 eye drops to placebo for the treatment of both the signs and symptoms of dry eye syndrome. This study design is based on the results in both ARISE-1 and ARISE-2 trials previously conducted by the Company. "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," stated officials at the Company.

Dry eye syndrome is a common condition affecting millions of Americans. Dry eye syndrome is a disease where loss of homeostasis of the tear film results in pain, itching, blurry visions, dryness, etc. RGN-259 eye drops contain the active small protein, thymosin beta 4, which is naturally-occurring in tears, other body fluids, and cells. RGN-259 eye drops have wide-ranging protective, repair, and regenerative activities. Such multifunctional activities underlie the efficacy of RGN-259 eye drops in both the signs and symptoms of dry eye. Furthermore, RGN-259 eye drops are safe and well-tolerated by the patients, and in both ARISE-1 and ARISE-2, patients reported minimal ocular discomfort on instillation that was similar to that of the placebo.

Recently, it has been reported that Novartis acquired Xiidra, the first prescription drug approved for the treatment of both the signs and symptoms of dry eye disease. "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.

About ReGenTree, LLC

ReGenTree is a U.S. joint venture company owned by GtreeBNT Co., Ltd, and RegeneRx Biopharmaceuticals, Inc. specifically to develop RGN-259 in both the USA and Canada for ophthalmic indications. ReGenTree licensed the rights to RGN-259 from RegeneRx in 2015. Thus far, ReGenTree has completed two Phase 3 studies in the U.S. for dry eye which are ARISE-1 (Phase 2b/3) and ARISE-2 (Phase 3). In addition to dry eye, the company is currently conducting a Phase 3 study for neurotrophic keratopathy (NK), an orphan indication in ophthalmology. For additional information about ReGenTree, please visit

Forward-Looking Statements

Any statements in this press release that are not historical facts are forward-looking statements made under the provisions of the Private Securities Litigation Reform Act of 1995. Any forward-looking statements involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. There can be no assurance that any current or future clinical trials will result in approved products or future value. There can also be no assurance that the Company will apply for an NDA in the future or that if the Company applies for an NDA, that it will be accepted by the FDA and/or that the product candidate will be approved for marketing in the U.S. Any forward-looking statements in this press release represent the Company's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date.  The Company specifically disclaims any obligation to update this information as a result of future events or otherwise, except as required by applicable law.

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Last Updated: 12-May-2019