Eyeworld

SEP 2015

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

Issue link: https://digital.eyeworld.org/i/569879

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Once-Daily PAZEO TM Solution PAZEO™ Solution: Safety Profile Well tolerated 1 The safety and effectiveness of PAZEO™ Solution have been established in patients two years of age and older 1 The most commonly reported adverse reactions, occurring in 2% to 5% of patients, were blurred vision, dry eye, superficial punctate keratitis, dysgeusia, and abnormal sensation in eye 1 Once-daily dosing 1 INDICATION AND DOSING PAZEO ™ Solution is indicated for the treatment of ocular itching associated with allergic conjunctivitis. The recommended dosage is to instill one drop in each affected eye once a day. IMPORTANT SAFETY INFORMATION As with any eye drop, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle to prevent contaminating the tip and solution. Keep bottle tightly closed when not in use. Patients should not wear a contact lens if their eye is red. PAZEO ™ Solution should not be used to treat contact lens-related irritation. The preservative in PAZEO ™ Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red should be instructed to wait at least ve minutes after instilling PAZEO ™ Solution before they insert their contact lenses. The most commonly reported adverse reactions in a clinical study occurred in 2%-5% of patients treated with either PAZEO ™ Solution or vehicle. These events were blurred vision, dry eye, super cial punctate keratitis, dysgeusia, and abnormal sensation in eye. For additional information on PAZEO™ Solution, please refer to the brief summary of the full Prescribing Information on the following page. References: 1. PAZEO™ Solution Package Insert. 2. Data on fi le, 2011. 3. Data on fi le, 2013. From Alcon, committed to providing treatment options for patients. Once-Daily PAZEO™ Solution for relief of ocular allergy itch: The first and only FDA-approved once-daily drop with demonstrated 24-hour ocular allergy itch relief 1 Statistically significantly improved relief of ocular itching compared to PATADAY® (olopatadine hydrochloride ophthalmic solution) 0.2% at 24 hours post dose (not statistically significantly different at 30-34 minutes) 1 Statistically significantly improved relief of ocular itching compared to vehicle through 24 hours post dose 1 Give your patients 24 HOURS OF OCULAR ALLERGY ITCH RELIEF with once-daily PAZEO™ Solution 1 Olopatadine is licensed from Kyowa Hakko Kirin Co., Ltd. Japan ©2015 Novartis 6/15 PAZ15093JAD ITCH RELIEF 24 HOURS OF OCULAR ALLERGY IN ONE DROP Study design: Two multicenter, randomized, double-masked, parallel-group, vehicle- and active-controlled studies in patients at least 18 years of age with allergic conjunctivitis using the conjunctival allergen challenge (CAC) model (N=547). Patients were randomized to receive study drug or vehicle, 1 drop per eye on each of 2-3 assessment days. On separate days, antigen challenge was performed at 27 (±1) minutes post dose to assess onset of action, at 16 hours post dose (Study 1 only), and at 24 hours post dose. Itching scores were evaluated using a half-unit scale from 0=none to 4=incapacitating itch, with data collected 3, 5, and 7 minutes after antigen instillation. The primary objectives were to demonstrate the superiority of PAZEO™ Solution for the treatment of ocular allergy itch. Study 1: PAZEO™ Solution vs vehicle at onset of action and 16 hours. Study 2: PAZEO™ Solution vs vehicle at onset of action; PAZEO™ Solution vs PATADAY® Solution, PATANOL® (olopatadine hydrochloride ophthalmic solution) 0.1%, and vehicle at 24šhours. 1-3

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