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...