Generally safe and well tolerated in clinical trial experience
Incidence of adverse events similar to saline control and TAcs1
- Most commonly reported treatment-emergent adverse events (≥1%) in clinical studies included randomized, double-blind, parallel-group, placebo- and/or active-controlled, and pharmacokinetic/pharmacodynamic studies with follow-up ranging from 6 to 24 weeks
- Incidence in which the adverse event rate is higher for ZILRETTA™ (triamcinolone acetonide extended-release injectable suspension) than saline control.
Radiographic changes vs saline control and TAcs2
- Radiographic changes in a Phase 3, randomized, double-blind, parallel-group, placebo- and active-controlled study (N=484) among patients with baseline and Week 24 injected knee radiographs
TAcs=triamcinolone acetonide crystalline suspension.