SAFETY & TOLERABIILITY PROFILE
XIIDRA® DEMONSTRATED A GENERALLY SAFE AND WELL-TOLERATED SAFETY PROFILE†
In 5 clinical studies of Dry Eye Disease with lifitegrast ophthalmic solution, 1401 patients received at least one dose of lifitegrast (1287 of which received XIIDRA®). The majority of patients (84%) had up to 3 months of treatment exposure. 170 patients were exposed to XIIDRA® for approximately 12 months.
| Most Common Adverse Reactions in ≥ 10% treated with XIIDRA® | |
|---|---|
| Eye Irritation | 18% |
| Eye Pain | 13% |
| Instillation Site Reactions | 12% |
| Dysgeusia | 14% |
In the 12-month, multicentre, randomized, double-masked, phase III study, the safety of XIIDRA® compared to vehicle was evaluated in a total of 332 patients (262 completed) with Dry Eye Disease. The safety profile observed in this long-term study was similar to that seen in the short-term, 12-week study.1
For more information refer to the Important Safety Information
† When used as indicated
Reference :
1. XIIDRA® Product Monograph. Novartis Pharmaceuticals Canada Inc. February 13, 2020.