NOV 2015

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

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INDICATIONS AND USAGE SIMBRINZA ® (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fixed combination indicated in the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Dosage and Administration The recommended dose is one drop of SIMBRINZA ® Suspension in the affected eye(s) three times daily. Shake well before use. SIMBRINZA ® Suspension may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. IMPORTANT SAFETY INFORMATION Contraindications SIMBRINZA ® Suspension is contraindicated in patients who are hypersensitive to any component of this product and neonates and infants under the age of 2 years. Warnings and Precautions Sulfonamide Hypersensitivity Reactions—Brinzolamide is a sulfonamide, and although administered topically, is absorbed systemically. Sulfonamide attributable adverse reactions may occur. Fatalities have occurred due to severe reactions to sulfonamides. Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration. If signs of serious reactions or hypersensitivity occur, discontinue the use of this preparation. Corneal Endothelium—There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Severe Hepatic or Renal Impairment (CrCl <30 mL/min)—SIMBRINZA ® Suspension has not been specifically studied in these patients and is not recommended. Contact Lens Wear—The preservative in SIMBRINZA ® Suspension, benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of SIMBRINZA ® Suspension but may be reinserted 15 minutes after instillation. Severe Cardiovascular Disease—Brimonidine tartrate, a component of SIMBRINZA ® Suspension, had a less than 5% mean decrease in blood pressure 2 hours after dosing in clinical studies; caution should be exercised in treating patients with severe cardiovascular disease. Adverse Reactions SIMBRINZA ® Suspension In two clinical trials of 3 months' duration with SIMBRINZA ® Suspension, the most frequent reactions associated with its use occurring in approximately 3-5% of patients in descending order of incidence included: blurred vision, eye irritation, dysgeusia (bad taste), dry mouth, and eye allergy. Adverse reaction rates with SIMBRINZA ® Suspension were comparable to those of the individual components. Treatment discontinuation, mainly due to adverse reactions, was reported in 11% of SIMBRINZA ® Suspension patients. Study Design: A prospective, randomized, multicenter, double-blind, parallel-group study of 189 patients with open-angle glaucoma and/or ocular hypertension receiving treatment with a PGA. PGA treatment consisted of either travoprost, latanoprost, or bimatoprost. Patients in the study were randomized to adjunctive treatment with SIMBRINZA ® Suspension (N=88) or vehicle (N=94). The primary efficacy endpoint was mean diurnal IOP (IOP averaged over all daily time points) at Week 6 between treatment groups. Key secondary endpoints included IOP at Week 6 for each daily time point (8 am, 10 am, 3 pm, and 5 pm) and mean diurnal IOP change from baseline to Week 6 between treatment groups. 1 ADD SIMBRINZA ® Suspension to a PGA for Even Lower IOP 1 * Prescribe SIMBRINZA ® Suspension as adjunctive therapy to a PGA for appropriate patients SIMBRINZA ® Suspension should be taken at least five (5) minutes apart from other topical ophthalmic drugs Learn more at myalcon.com/simbrinza For additional information about SIMBRINZA ® Suspension, please see Brief Summary of full Prescribing Information on adjacent page. Reference: 1. Data on file, 2014. © 2015 Novartis 3/15 SMB15017JAD 5.6 † mm Hg addi- tional mean diurnal IOP lowering ob- served from baseline when added to a PGA 1 Up to 7.1 mm Hg additional IOP reduction from baseline when added to a PGA 1 * PGA study-group treatment consisted of either travoprost, latanoprost, or bimatoprost. † Treatment difference (mm Hg) and P-value at Week 6 was -3.7, P<0.0001. IOP Time Points (mm Hg) 1‡ Treatment Arm 8 am 10 am 3 pm 5 pm PGA + SIMBRINZA ® Suspension (N=83) Baseline § 24.5 22.9 21.7 21.6 Week 6 19.4 15.8 17.2 15.6 PGA + Vehicle (N=92) Baseline § 24.3 22.6 21.3 21.2 Week 6 21.5 20.3 20.0 20.1 ‡ Least squares means at each Week 6 time point. Treatment differences (mm Hg) and P-values at Week 6 time points between treatment groups were: -2.14, P=0.0002; -4.56, P<0.0001; -2.84, P<0.0001; -4.42, P<0.0001. § Baseline (PGA Monotherapy). Mean Diurnal IOP (mm Hg) 1|| Treatment Arm PGA + SIMBRINZA ® Suspension (N=83) Baseline ¶ 22.7 Week 6 17.1 PGA + Vehicle (N=92) Baseline ¶ 22.4 Week 6 20.5 || Treatment difference (mm Hg) and P-value at Week 6 was -3.4, P<0.0001. ¶ Baseline (PGA Monotherapy).

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