Trial’s controlled design was expected to quantify the original contribution of stem cells in the IMP. Credit: Petr Novák/Wikipedia.

Ophthalmic medications developer ReGenTree has commenced a Phase III clinical trial to assess 0.1% RGN-259 eye drops in patients suffering from dry eye syndrome.

RGN-259 eye drops are made up of thymosin beta 4, an active small protein that occurs naturally in tears, other body fluids and cells. The medication is said to possess protective, repair and regenerative activities.

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It has been developed as a single unit dose using the company’s manufacturing technology and blow-fill-seal technology.

Dry eye syndrome is a common disease characterised by loss of homeostasis of the tear film, leading to pain, itching, blurry visions, and dryness, among others.

“The trial will recruit 700 patients with dry eye syndrome at about fifteen nationwide clinical sites.”

Named ARISE-3, the randomised, double masked, placebo-controlled Phase III trial will compare the safety and efficacy of RGN-259 eye drops to placebo in treating the signs and symptoms of dry eye.

ReGenTree said in a statement: “The trial will recruit 700 patients with dry eye syndrome at about fifteen nationwide clinical sites, including hospitals and clinics specialised in ophthalmology, and will be completed in the middle of next year.”

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The Phase III trial is based on data obtained from the previous ARISE-1 and ARISE-2 studies, where RGN-259 eye drops were found to be safe and well-tolerated. Data also showed minimal ocular discomfort on instillation similar to that of placebo.

ReGenTree is a US-based joint venture (JV) company of GtreeBNT and RegeneRx Biopharmaceuticals. The JV has been specifically formed to develop RGN-259 for ophthalmic indications in the US and Canada.

The company licensed the rights to RGN-259 from RegeneRx in 2015. Apart from dry eye syndrome, RGN-259 is being developed for the treatment of neurotrophic keratopathy.