Tarsius Announces FDA Acceptance of TRS01 IND Application

Tarsius Pharma announced the acceptance of its Investigational New Drug (IND) application for TRS01 by the U.S. Food and Drug Administration (FDA).

The company is developing TRS, a bio-inspired platform technology for the treatment of blinding ocular diseases. TRS was developed to 're-engineer' the immune system, and approaches inflammatory diseases from within the system. This IND acceptance will enable Tarsius to initiate enrollment in its planned Phase I/II clinical trial of TRS01.

The planned study is a multi-center, randomized, placebo-controlled dose-ranging study in patients with ocular inflammation following cataract surgery. This study is designed to determine the safety profile of TRS01, the recommended dose, and preliminary evaluation of the potential effect of TRS01 in ocular inflammation.

"The FDA's acceptance of our IND for TRS01 is a critical milestone for patients, as we are now one step closer to bring a new treatment that will transform the lives of people with serious blinding diseases," said Dr. Daphne Haim-Langford, Founder and CEO, Tarsius Pharma.

"This is an exciting time for us, and we look forward to embarking on our next chapter as a clinical stage company," said Zohar Milman, Tarsius COO.

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 devastating consequences.

The TRS Platform Technology has the potential to effectively treat a broad array of autoimmune and inflammatory ocular diseases. Untreated, these diseases can have devastating effects, and may eventually lead to blindness.

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