Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TRS01 · 1 trial · 2 indications
For FDA submission: the percentage of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells).
For submission to European Medicines Agency (EMA) related countries: the percentage of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.
| Arm | Type | Description |
|---|---|---|
| TRS01 | EXPERIMENTAL | - |
| Active comparator | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TRS01 | DRUG | TRS01 eye drops Dosed four times a day (QID) |
| FDA approved steroid eye drop (masked) | DRUG | FDA approved steroid eye drop Dosed four times a day (QID) |
Inclusion Criteria: * At sites in the US: Male or female up to and including 75 years of age (including all pediatric age groups). At sites in the Europe: Male or female between 18 and 70 years of age, inclusive. * Diagnosed with active non-infectious anterior uveitis with anterior chamber cell Gra...
TRS01 is an investigational small molecule being developed for the treatment of non-infectious anterior uveitis, an inflammatory condition of the eye. It is also being studied in patients with uveitic glaucoma, a complication of uveitis that involves elevated eye pressure. The drug is administered as a topical ophthalmic treatment.
TRS01 is being developed by Tarsier Pharma Ltd., a biopharmaceutical company focused on ophthalmology. Tarsier Pharma trades on the stock market under the ticker symbol TARX. The company is conducting clinical trials to evaluate the safety and efficacy of TRS01 in patients with non-infectious anterior uveitis.
TRS01 is currently in Phase 3 clinical development. It has completed a Phase 3 study in patients with active non-infectious anterior uveitis, including those with uveitic glaucoma. The drug is still investigational and has not been approved by regulatory authorities such as the FDA.
TRS01 has been studied in one completed Phase 3 clinical trial with the identifier NCT05042609. This randomized, double-blind, active-controlled study enrolled 142 participants with non-infectious anterior uveitis and uveitic glaucoma. The trial was conducted in the United States, France, and Germany.
TRS01 is a small molecule designed to treat non-infectious anterior uveitis by targeting inflammatory pathways in the eye. As a topical treatment, it is intended to reduce inflammation and potentially manage elevated intraocular pressure associated with uveitic glaucoma. The specific molecular target of TRS01 has not been disclosed.