Tarsier Pharma, Ltd., a clinical-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases, today announced the successful outcome of a Type C meeting with the U.S. Food and Drug Administration (FDA), supporting the advancement of TRS01 eye drop formulation for the treatment of noninfectious uveitis into a registrational program based on the recently completed TRS4Vision trial.
“We are pleased to have FDA agreement on the primary and key secondary endpoints for the registrational program of TRS01 which we believe has the potential to be first-in-class first line treatment for noninfectious uveitis and specifically in uveitic glaucoma” said Zohar Milman, MSc. Chief Operational Officer of Tarsier. “We are grateful for the FDA’s support and guidance and look forward to continue the professional discussions as we advance TRS01 development.”
The Type C meeting was supported by results from the previously completed TRS4Vision trial – a randomized, double-masked, active-controlled Phase 3 trial that was designed to evaluate the efficacy and safety of TRS01 eye drop formulation in noninfectious uveitis patients including uveitic glaucoma patients. In the TRS4Vision trial, TRS01 was found to be active in clearing inflammation, reducing ocular pain and exhibited a compelling risk/benefit profile, minimizing the concerns of Intraocular Pressure (IOP) increase during the course of treatment.
The upcoming trial is intended to replicate the TRS4Vision trial, with a revised endpoints in accordance with FDA discussions. The revised endpoints specifically designed to emphasize the risk/benefit profile of TRS01. The primary endpoint chosen has already attained statistical significance in the TRS4Vision trial, with a p-value <0.01.
“The results from the TRS4Vision trial demonstrates that TRS01 has a positive risk/benefit profile for the most vulnerable eyes that already reached the stage of uveitic glaucoma,” stated Quan Dong Nguyen, MD, MSc, FAAO, FARVO, FASRS, Professor of Ophthalmology, Medicine, and Pediatrics at the Byers Eye Institute, Stanford University School of Medicine, and who is an international leader in Uveitis and Ocular Inflammatory Diseases and the President of the International Ocular Inflammation Society (IOIS) “There is growing evidence on the substantial risk of increased IOP in uveitis and a clear understanding that we need a steroid-free first line treatment for the active phase of anterior non-infectious uveitis. The data thus far support that the TRS01 profile has the potential to slow or prevent clinically meaningful progression of glaucoma in noninfectious uveitis and serve as first line treatment in uveitic glaucoma,” said Professor Nguyen.