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.

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