Tarsier Pharma Secures FDA Agreement for Phase 3 Trial of Ophthalmic Solution for Uveitis
FDA & EMA / 18 January 2024
Tarsier Pharma has received FDA approval for its Phase 3 trial of TRS01, an innovative ophthalmic solution for non-infectious uveitis and uveitic glaucoma. The trial, backed by successful previous studies, aims to provide a steroid-free treatment option for these chronic eye conditions.
Tarsier Pharma announced receiving a Special Protocol Assessment (SPA) agreement from the U.S. Food and Drug Administration (FDA) for its Phase 3 Tarsier-04 trial, a significant milestone in evaluating TRS01 eye drops. This ophthalmic solution targets non-infectious uveitis and uveitic glaucoma. TRS01's unique mechanism targets macrophage modulation, potentially changing treatment for various ocular diseases.
A Critical Milestone for Ocular Health
A SPA agreement signifies the FDA's concurrence with adequacy and acceptability of key elements in the overall protocol design of a study intended to support future marketing applications. “The SPA agreement with the FDA provides a clear regulatory path for TRS01,” said Daphne Haim Langford, CEO of Tarsier Pharma.
The upcoming Tarsier-04 trial protocol, approved by the FDA, was designed to mirror the TRS4Vision trial, featuring revised endpoints. These aim to highlight the benefit/risk profile of TRS01, drawing from insights gained in the TRS4Vision trial.
“The primary endpoint in this FDA approved protocol is one that achieved an alpha <0.01 in the TRS4Vision trial, thus we have strong reasons to believe that the endpoints of Tarsier-04 will be met,” added Haim-Langford.
Patients dealing with non-infectious uveitis endure a lifelong struggle to safeguard their vision. Despite current treatments, a majority of patients eventually suffer vision loss, significantly impacting their quality of life.
A New Frontier in Ophthalmic Treatment
TRS01, known scientifically as Dazdotuftide, showcases a novel and unique mechanism of action. This groundbreaking approach focuses on modulating macrophages, shifting them from an inflammatory state to an anti-inflammatory one. Tarsier is exploring this innovative compound not only as an eye drop for front-of-the-eye conditions but also as an intravitreal injection for back-of-the-eye diseases.
The Tarsier-04 Phase 3 trial
The Tarsier-04 Phase 3 trial, a multi-center, randomized, double-masked, and active-controlled study, is set to enroll up to 300 patients across the U.S. The trial's design aims to rigorously test the efficacy and safety of TRS01, particularly in patients suffering from non-infectious uveitis and uveitic glaucoma. The company's COO, Ms. Zohar Milman, expressed gratitude for the FDA's support and guidance, emphasizing Tarsier's commitment to initiating the trial swiftly.
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