JUN 2019

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: http://digital.eyeworld.org/i/1123870

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Page 69 of 70

Indication Xiidra ® (lifi tegrast ophthalmic solution) 5% is indicated for the treatment of signs and symptoms of dry eye disease (DED). Important Safety Information Xiidra is contraindicated in patients with known hypersensitivity to lifi tegrast or to any of the other ingredients. 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. References: 1. Xiidra [Prescribing Information]. Lexington, MA: Shire US. 2. TFOS DEWS II Research Subcommittee. Report of the Research Subcommittee of the Tear Film & Ocular Surface Society Dry Eye WorkShop II (2017). Ocul Surf. 2017;15(3):269-649. 3. FDA approves new medication for dry eye disease. FDA News Release. July 2016. http://www.fda.gov/newsevents/newsroom/pressannouncements/ ucm510720.htm. Accessed July 12, 2016. 4. Food and Drug Administration. Electronic Orange Book. http://www.fda.gov/ downloads/Drugs/DevelopmentApprovalProcess/UCM071436.pdf. Accessed June 26, 2018. There's no substitute. 2,4 Check out patient resources, insurance coverage, and more at Xiidra-ECP.com Xiidra, the fi rst in a class of LFA-1 antagonists for Dry Eye Disease, is a prescription eye drop FDA-approved to treat both signs and symptoms of the disease. 1,3 Xiidra is the only lymphocyte function-associated antigen-1 (LFA-1) antagonist treatment for Dry Eye Disease 1,2 THERE'S NO SWIITCHING THIS For additional safety information, see accompanying Brief Summary of Safety Information on the adjacent page and Full Prescribing Information on Xiidra-ECP.com. ©2018 Shire US Inc., Lexington, MA 02421. 1-800-828-2088. All rights reserved. SHIRE and the Shire Logo are trademarks or registered trademarks of Shire Pharmaceutical Holdings Ireland Limited or its affi liates. Marks designated ® and ™ are owned by Shire or an affi liated company. S41341 07/18

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