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Tarsius Pharma Announces Granting Of Orphan Drug Designation For TRS By The European Medicines Agency

Nov. 19, 2019

TRS is a novel drug for the treatment of blinding ocular diseases

TEL AVIV, Israel, Nov. 19, 2019 /PRNewswire/ — Tarsius Pharma today announced that the European Medicines Agency (EMA), the European equivalent of the FDA, approved the designation of orphan drug for its TRS for treatment of non-infectious uveitis and has acknowledged the clinically relevant advantage for TRS in non-infectious uveitis patients with 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.”

Orphan drug designations facilitate development of drugs for rare diseases.

Dr Daphne Haim-Langford, Tarsius Founder and CEO, stated, “I am pleased that the EMA acknowledges the potential of our TRS to treat those patients suffering from uveitic glaucoma, who have no safe treatment available and have a high risk for blindness.”

“This is the first time that authorities are formally recognizing the unmet need of patients suffering from uveitis associated with glaucoma,” stated Dr Ron Neumann, Tarsius CMO. “This approval enables us to proceed to Phase I/II in our clinical trials, supported by the acknowledgment of the EMA of the indication.”

About Ocular Inflammatory Diseases

Ocular inflammatory diseases impose a significant medical and economic burden on society, affecting hundreds of million people worldwide and posing severe risks of vision loss and blindness.

In more than 50 years, corticosteroids are the most common method used to treat ocular non-infectious inflammation of any kind. Rather than treating the disease itself, however, steroids merely relieve its symptoms, and long-term use can result in life-changing consequences.

The TRS Platform Technology has the potential to effectively treat a broad array of autoimmune and inflammatory ocular diseases.

About the Company

Tarsius Pharma was established in 2016 and is focused on developing TRS, a breakthrough, bio-inspired platform technology for the treatment of blinding ocular diseases.

The company’s investors include Sun Pharmaceuticals, a global pharmaceutical company, BioLight Life Sciences Ltd, as well as private investors and family offices. This project has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No. 879598.  

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