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Dazdotuftide: A Novel Treatment for Non-Infectious Uveitis Demonstrating a Superior Intraocular Pressure Safety Profile in a Randomized Clinical Trial
Presenter:
David S. Chu, MD
Authors:
David S. Chu, Edmund Tsui, Lana M. Rifkin, Alan G. Palestine, Cadmus Rich, Jennifer E. Thorne, Daphne Haim-Langford, Zohar Milman, Emilee Fulcher, Ron Neumann, Marc D. de Smet, TRS4Vision Study Group
David S. Chu: Metropolitan Eye Research and Surgery Institute, Palisades Park, NJ, USA; Institute of Ophthalmology and Visual Science, New Jersey Medical School, Rutgers University, NJ, USA
Edmund Tsui: Ocular Inflammatory Disease Center, UCLA Jules Stein Eye Institute, Los Angeles, USA; Department of Ophthalmology, David Geffen School of Medicine at UCLA, University of California, Los Angeles, CA, USA
Lana M. Rifkin: Ophthalmic Consultants of Boston, Boston, MA, USA
Alan G. Palestine: Department of Ophthalmology, University of Colorado School of Medicine, Aurora, CO, USA
Cadmus Rich: Tarsier Pharma Ltd., Israel
Jennifer E. Thorne: Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; The Department of Epidemiology, The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
Daphne Haim-Langford: Tarsier Pharma Ltd., Israel
Zohar Milman: Tarsier Pharma Ltd., Israel
Emilee Fulcher: Tarsier Pharma Ltd., Israel
Ron Neumann: Tarsier Pharma Ltd., Israel
Marc D. de Smet: Microinvasive Ocular Surgery Institute, Lausanne, CH; New York Eye and Ear Infirmary of Mt Sinai, Icahn School of Medicine, NYC, USA; Dept Ophthalmology, Université libre de Bruxelles, Belgium
Affiliation:
Purpose: To assess the safety and efficacy of dazdotuftide (TRS01 eye drops), a novel, steroid-free, anti-inflammatory drug for active anterior non-infectious uveitis (NIU), building on earlier studies indicating a favorable risk/benefit profile with regards to safety and specifically intraocular pressure (IOP) safety profile.
Methods: A randomized, double‑masked, multicenter, active‑controlled Phase 3 clinical trial. Eligible participants included adults (≤75 years) and pediatric patients with active anterior NIU, with or without uveitic glaucoma, who either were on stable NIU therapy or had not received prior treatment and required management for an acute flare. All enrolled patients had Anterior Chamber Cell (ACC) Grades 2 or 3 on a Visual Analog Scale in the study eye. Participants were randomized 2:1 to receive topical TRS01 1% or prednisolone acetate 1% four times daily for 28 days. Assessments included slit‑lamp examination, ocular pain, Best‑Corrected Visual Acuity, IOP and dilated ophthalmoscopy.
Results: A total of 136 patients were included in the Full Analysis Set with a mean age of 43 years in the TRS01 arm and 42 years in the prednisolone acetate arm. 48% of TRS01 vs. 68% of prednisolone acetate patients achieved ACC Grade=0 on Day 28 (95.1% Confidence Interval (CI): -0.37, -0.02; p=0.0311) and 64% of TRS01 vs. 89% prednisolone acetate patients experienced clinically meaningful improvement of ACC Grade=0 or 1, i.e. ≤5 cells (95.1% CI: -0.33, -0.06; p=0.0049). Although TRS01 was found to be inferior to topical steroids to control ACC, it was non‑inferior to topical steroids to control flare and ocular pain. Notably, TRS01 exhibited a superior IOP safety profile compared to topical steroids. Among patients achieving ACC=0, TRS01-treated patients benefited from statistically significantly improved IOP outcomes (including change from baseline and at each IOP threshold evaluated [p < 0.05]) versus steroid‑treated patients.
Conclusions: TRS01 offers the potential to serve as an effective and safe treatment option for NIU that meets the urgent need for a drug that controls inflammation without the steroids’ associated risk of IOP elevation.