Tarsier Pharma Announces Successful Type C Meeting with FDA for TRS01 in Noninfectious Uveitis
TEL-AVIV, Israel, Nov. 13, 2023 /PRNewswire/ -- 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 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.
- The upcoming trial is intended to replicate the TRS4Vision trial, with a revised endpoints in accordance with FDA discussions.
- 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.