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OCULAR INFLAMMATORY DISEASES

Ocular inflammatory diseases are a group of diseases affecting the front and back of the eye. Non-infectious anterior and posterior uveitis are the most known ocular inflammatory diseases. However, ocular inflammation is an important underlying mechanism in the pathology of other eye diseases, such as diabetic macular edema (DME), non-proliferative diabetic retinopathy (NPDR), and dry age-related macular degeneration (AMD). Hundreds of millions of people in all age groups are suffering from ocular inflammatory diseases worldwide, conditions that pose severe risks of vision loss and blindness.

For more than 70 years, corticosteroids are the most common method used to treat ocular non-infectious inflammation of any kind. However, rather than treating the disease itself, steroids merely relieve its symptoms, and long-term use can result in life-changing consequences.

TRS, our breakthrough platform technology, approaches inflammatory diseases from within the immune system. We are implementing a patented, proprietary new molecule which was developed to ‘re-engineer’ the immune system. We believe this approach will provide patients with a safe and long-lasting therapeutic effect, with the goal of saving their sight.

TRS01 was evaluated in a Phase 1/2a clinical trial with 16 patients with active non-infectious anterior uveitis. PoC results proved safety and efficacy. In addition, improvement in signs and symptoms was demonstrated in critical measures such as ACC (Anterior Chamber Cells) and pain reduction.

Currently TRS01 is being evaluated further in a phase-3 trial, called TRS4VISION, in patients with active non-infectious anterior uveitis including patients with uveitic glaucoma. More information about the trial can be found on ClinicalTrials.gov, here.

Tarsier® Pharma is developing the TRS Platform Technology in two administration routes for treatment of the following ocular conditions:

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CLINICAL INDICATIONS

For our first clinical indication, we have chosen to focus on a treatment for uveitis glaucoma, for patients who currently have no treatment alternatives, and have a high chance of going blind. Uveitis glaucoma is a severe late stage blinding condition, which occurs when a patient develops glaucoma on top of uveitis. Non-infectious uveitis is responsible for 10-15% of all cases of blindness, with approximately 30,000 new cases diagnosed annually. The prevalence of blindness secondary to uveitis has not been reduced in the past 30 years, which strongly reflects the inadequacy of current management approaches and the unmet need for effective therapies. Uveitis has a strong socioeconomic impact because 60–80% uveitis patients are professionally active with a mean age of 35.

Treatment of uveitis addresses aspects of inflammation, pain and structural adhesions formed between adjacent structures within the eye.  Long-term management constitutes preventive measures to avoid relapses. Once the disease progresses onto uveitic glaucoma, the first line treatment option and the only approved topical treatment – corticosteroids – is contraindicated. 30% of patients with uveitis will also develop glaucoma which is the #1 cause of blindness. 

The European Medicines Agency (EMA) approved the designation of orphan drug for TRS for treatment of non-infectious uveitis and has acknowledged the clinically relevant advantage for TRS in non-infectious uveitis for patients with uveitic glaucoma not eligible for corticosteroid treatment. The EMA further stated in their decision that use of TRS will be of “significant benefit to those affected by the condition, which is chronically debilitating due to visual loss, leading to significant visual impairment or legal blindness in up to 35% of patients.”

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