Marks designated
®
and
™
are owned by Shire or an affi liated company.
©2016 Shire US Inc. Lexington, MA 02421 S24435 11/16
IIMPROVEMENT
SIGN & SYMPTOM
The only prescription eye drop FDA-approved to treat
both the signs and symptoms of Dry Eye Disease
Xiidra improved patient-reported
symptoms of eye dryness and improved
signs of inferior corneal staining. So help
patients get to know Xiidra.
Check it out at Xiidra-ECP.com
Four randomized, double-masked, 12-week trials
evaluated the effi cacy and safety of Xiidra versus
vehicle as assessed by improvement in the signs
(measured by Inferior Corneal Staining Score)
and/or symptoms (measured by Eye Dryness Score)
of Dry Eye Disease (N=2133).
The safety of lifi tegrast was evaluated in 5 clinical
studies. 1401 patients received at least one dose of
lifi tegrast (1287 of which received Xiidra). The most
common adverse reactions (5-25%) were instillation
site irritation, dysgeusia, and reduced visual acuity.
Indication
Xiidra
®
(lifi tegrast ophthalmic solution) 5% is indicated for the treatment
of signs and symptoms of dry eye disease (DED).
Important Safety Information
In clinical trials, the most common adverse reactions reported in 5-25%
of patients were instillation site irritation, dysgeusia and reduced visual
acuity. Other adverse reactions reported in 1% to 5% of the patients were
blurred vision, conjunctival hyperemia, eye irritation, headache, increased
lacrimation, eye discharge, eye discomfort, eye pruritus and sinusitis.
To avoid the potential for eye injury or contamination of the solution,
patients should not touch the tip of the single-use container to their
eye or to any surface.
Contact lenses should be removed prior to the administration of Xiidra
and may be reinserted 15 minutes following administration.
Safety and effi cacy in pediatric patients below the age of 17 years have
not been established.
Please see the adjacent page for Brief Summary of Safety Information
and visit Xiidra-ECP.com for Full Prescribing Information.
