MAR 2014

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

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Page 43 of 210

E W NEWS & OPINION 4 1 that could be identified, Dr. Applegate said. A s a rule, for the normal healthy population, acuity doesn't start dete- riorating until individuals are about age 65, he said. "Well into the sev- enth decade of life the optical prop- erties of a typical well-corrected eye provide for acuities that are better than 20/20 on average," Dr. Applegate said. "But there's a sub- p opulation that behaves differently." He pointed out that by the time a person reaches 80 the average eye has lost more than one line of acu- ity. "If we can identify those on a fast track to vision loss prior to the vision loss, the field will have new sensitive tools to better and more efficiently evaluate medical therapy designed to slow cataract progres- sion," Dr. Applegate said. Disappearing letters When investigators examined those patients whose eyes were losing acu- ity the fastest, they were able to find some interesting correlations, Dr. Koenig observed. "We looked at the full population, 160 subjects in total, and then as part of our analy- sis we looked at just those who had lost at least four letters of acuity over the four-year study period," he said. "We found that those whose acuity changed the most also drove the change in the full population." Dr. Applegate cited four factors in a multiple regression analysis driving the correlation. "In order, these are entropy of the point spread function, posterior subcapsular cataract, trefoil, which is typically associated with cortical cataract, and finally age, which captures all kinds of factors." While age was signifi- cant, it was the last factor to enter the regression model and improved the correlation only marginally. "The major factor driving the regres- sion model was a change in optical quality easily measured with a wavefront sensor," Dr. Applegate observed. As Dr. Koenig explained, en- tropy is an optical quality metric. "All objects are made up of millions of points. How the optics of the eye image a point is used to define image quality metrics. Someone with ideal vision and ideal optics should image a point sharply to a point image," he said. "In the case of those who lost acuity, the point image and the resulting point spread was less sharp and that was well c aptured in the optical quality metric called entropy." He was a bit surprised that pos- terior subcapsular cataract had a role h ere since existence of this was an exclusion factor for those who par- ticipated in the study. "Because pos- terior subcapsular cataract is well k nown to reduce visual function and easy to detect with a slit lamp, we March 2014 © 2013 Novartis 9/13 SMB13064JAD TM (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% ONE BOTTLE. MANY POSSIBILITIES. For the treatment of elevated IOP UNLOCK TREATMENT POSSIBILITIES SIMBRINZA ™ Suspension provided additional 1-3 mm Hg IOP lowering compared to the individual components 1 ■ IOP measured at 8 AM, 10 AM, 3 PM, and 5 PM was reduced by 21-35% at Month 3 2-4 ■ Effi cacy proven in two pivotal Phase 3 randomized, multicenter, double-masked, parallel-group, 3-month, 3-arm, contribution-of-elements studies 2,3 ■ The most frequently reported adverse reactions (3-7%) in a six month clinical trial were eye irritation, eye allergy, conjunctivitis, blurred vision, dysgeusia (bad taste), conjunctivitis allergic, eye pruritus, and dry mouth 5 ■ Only available beta-blocker-free fi xed combination 2,3 Learn more at myalcon.com/simbrinza References: 1. SIMBRINZA ™ Suspension Package Insert. 2. Katz G, DuBiner H, Samples J, et al. Three-month randomized trial of fi xed-combination brinzolamide, 1%, and brimonidine, 0.2% [published online ahead of print April 11, 2013]. JAMA Ophthalmol. doi:10.1001/jamaophthalmol.2013.188. 3. Nguyen QH, McMenemy MG, Realini T, et al. Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fi xed-combination brinzolamide 1%/brimonidine 0.2%. J Ocul Pharmacol Ther. 2013;29(3): 290-297. 4. Data on fi le, 2013. 5. Whitson JT, Realini T, Nguyen QH, McMenemy MG, Goode SM. Six-month results from a Phase III randomized trial of fi xed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension. Clin Ophthalmol. 2013;7:1053-1060. INDICATIONS AND USAGE SIMBRINZA ™ (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2% is a fi xed 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 fi ve (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 specifi cally studied in these patients and is not recommended. Adverse Reactions 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. Drug Interactions—Consider the following when prescribing SIMBRINZA™ Suspension: Concomitant administration with oral carbonic anhydrase inhibitors is not recommended due to the potential additive effect. Use with high-dose salicylate may result in acid-base and electrolyte alterations. Use with CNS depressants may result in an additive or potentiating effect. Use with antihypertensives/cardiac glycosides may result in additive or potentiating effect on lowering blood pressure. Use with tricyclic antidepressants may blunt the hypotensive effect of systemic clonidine and it is unknown if use with this class of drugs interferes with IOP lowering. Use with monoamine oxidase inhibitors may result in increased hypotension. For additional information about SIMBRINZA ™ Suspension, please see Brief Summary of full Prescribing Information on adjacent page. 84880 SMB13064JAD EW i dd 1 2/3/14 11:09 AM continued on page 42 18-47 News_EW March 2014-DL2 copy_Layout 1 3/6/14 2:47 PM Page 41

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