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Clinical trial of novel drug for treating inflammatory eye disease yields positive results

Aiming for a steroid-free future, EU-funded researchers are testing new eye drops designed to reprogramme the immune system of inflammatory eye disease sufferers.

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Ocular inflammatory diseases affect the front and back of the eye, leading to vision loss and blindness. For over 50 years, the treatment of ocular non-infectious inflammations has usually been based on corticosteroids. However, steroids relieve the symptoms, they don’t treat the disease itself. What’s more, their long-term use also poses severe health risks. To help the hundreds of millions of people worldwide who suffer from ocular inflammatory diseases, researchers from project coordinator Tarsius Pharma have developed novel treatments that fight the disease rather than simply improving the symptoms. This is made possible through a patented bio-inspired molecule that reprogrammes the immune system, disrupting the autoimmune mechanism responsible for the disease. With support from the EU-funded TRS project, the Tarsius Pharma scientists are conducting clinical trials to test the safety and efficacy of their new drug. In a recent news item posted on the ‘PR Newswire’ website, the project team announced the results of a trial of their TRS01 eye drops for treating active anterior non-infectious uveitis. Uveitis, the inflammation of the uvea, or middle layer of tissue surrounding the eye, is the most common of the ocular inflammatory diseases.

Trial results

Sixteen subjects with active non-infectious anterior uveitis participated in the randomised, double-masked, controlled phase I/II clinical trial that compared two different doses of TRS01. As stated in the news item, the trial results “demonstrated significant improvement in critical measures such as ACC (Anterior Chamber Cells), pain reduction and increased visual acuity.” Better results were noted with the higher dose of the drug in a few cases. Additionally, both high- and low-dose usage led to a reduction in intraocular pressure when compared with steroids. “The results of this clinical trial with TRS01 are truly impressive, and suggest meaningful progress towards the development of a novel and clinically important class of ocular therapeutics – topical anti-inflammatory agents with efficacy that is at least equal to corticosteroids, but with none of the known corticosteroid-associated side-effects,” observed Dr Ron Neumann, Tarsius Pharma’s Chief Marketing Officer. Through their research, the project team aims to provide patients with a safe and long-lasting treatment. “The results of this study bring us one big step forward in our journey to save the eye-sight of patients with uveitic glaucoma, who have no approved treatment available today for this devastating condition,” stated CEO Dr Daphne Haim-Langford in the same news item. The TRS (A paradigm change in the treatment of blinding ocular diseases) project’s future plans include clinical trials to test its TRS02 drug, an intravitreal injection. TRS02 will be used to treat ocular diseases such as diabetic macular oedema, intermediate posterior uveitis, panuveitis and dry age-related macular degeneration. For more information, please see: TRS project website

Keywords

TRS, ocular inflammatory disease, uveitis, TRS01, eye disease

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