Eyeworld Daily News

2020 EyeWorld Daily News Monday

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44 | EYEWORLD DAILY NEWS | MAY 18, 2020 DAILY NEWS ASCRS VIRTUAL ANNUAL MEETING Available by prescription only. ALLEVIATE WITH ZERVIATE ™ When ocular itch gets in the way of their day... ZERVIATE delivers the proven power of cetirizine— a leading oral allergy medication—now targeted to the eyes. 1,2,a • Clinically meaningful and rapid reduction in ocular itch vs vehicle at 15 minutes and 8 hours (P<0.0001 at all time points measured) 1,3 • Designed for comfortable delivery with Hydrella™, a glycerin and HPMC formulation 1,4 • Administered as a single drop, twice daily approximately 8 hours apart 1 STUDY DESIGN: The pivotal trials for ZERVIATE included two Phase 3, double-masked, randomized, vehicle-controlled, parallel-group studies involving 201 patients. Study 2 required more severe allergic conjunctivitis symptoms. Patients were screened for an allergen response using the conjunctival allergen challenge (CAC) model and randomized to receive either ZERVIATE or vehicle. Primary efficacy endpoints were ocular itching and conjunctival redness 15 minutes and 8 hours post treatment instillation. 3 INDICATIONS AND USAGE ZERVIATE™ (cetirizine ophthalmic solution) 0.24% is a histamine-1 (H1) receptor antagonist indicated for treatment of ocular itching associated with allergic conjunctivitis. DOSAGE AND ADMINISTRATION Instill one drop in each affected eye twice daily (approximately 8 hours apart). IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Contamination of Tip and Solution: As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle or tip of the single-use container in order to avoid injury to the eye and to prevent contaminating the tip and solution. Keep the multi-dose bottle closed when not in use. Discard the single-use container after using in each eye. Contact Lens Wear: Patients should be advised not to wear a contact lens if their eye is red. ZERVIATE should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of ZERVIATE. The preservative in ZERVIATE, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted 10 minutes following administration of ZERVIATE. ADVERSE REACTIONS The most commonly reported adverse reactions occurred in approximately 1–7% of patients treated with either ZERVIATE or vehicle. These reactions were ocular hyperemia, instillation site pain, and visual acuity reduced. Please see brief summary of Full Prescribing Information on the adjacent page. HPMC=hydroxypropyI methylcellulose. a Based on a U.S. News report on data from the 2019 Pharmacy Times Survey of Pharmacists' OTC Recommendations. References: 1. ZERVIATE [package insert]. Fort Worth, Texas: Eyevance Pharmaceuticals LLC; 2020. 2. U.S. News & World Report. Antihistamines for allergies. https://health.usnews.com/health-products/top-rec-antihistamines-oral-8. Accessed October 7, 2019. 3. Meier EJ, Torkildsen GL, Gomes PJ, et al. Phase Ill trials examining the efficacy of cetirizine ophthalmic solution 0.24% compared to vehicle for the treatment of allergic conjunctivitis in the conjunctival allergen challenge model. Clin Ophthalmol. 2018;12:2617-2628. 4. Malhotra RP, Meier E, Torkildsen G, et al. Safety of cetirizine ophthalmic solution 0.24% for the treatment of allergic conjunctivitis in adult and pediatric subjects. Clin Ophthalmol. 2019;13:403-413. © 2020 Eyevance Pharmaceuticals LLC. All rights reserved. ZERVIATE™ and Hydrella™ are trademarks of Eyevance Pharmaceuticals LLC. ZER-02-20-AD-22 Learn more at MyZerviate.com NEW

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