Eyeworld

59 February 2015 EW REFRACTIVE added that as this lens moves the silicone from the haptics into the optic, "it changes the curvature on the optic, and you get quite a large accommodating amplitude." Dr. Alio said trifocal IOLs in development with extended depth of focus work "on achromatization and adjustment of the IOL asphe- ricity. Piggyback multifocal IOLs are currently under study, both diffractive and refractive varifocal. We also have toric sulcus lenses for piggybacking. With all these lenses, we have an unlimited capability to indicate a multifocal lens, even in patients with a previous monofocal lens operated some time ago." The diffractive IOL is from Carl Zeiss Meditec (Jena, Germany) (refractive varifocal) and the refractive IOLs are the Mplus (Oculentis, Berlin) and the Rayner Sulcoflex (East Sussex, U.K.) (refractive multifocal). Dr. Mamalis acknowledged the strides that developers have made in trying to provide true accommo- dation. "[But] any lens that splits the image has the potential for the bothersome side effects associated with the multifocal lenses," he said. "A lot of people adapt quite well to them and do just fine. Some people don't. Those are the people who we have to consider doing a lens exchange." In Europe, several trifocal lenses are "doing pretty well," Dr. Cummings said, adding anecdotal evidence that these lenses are help- ing to grow a once-stagnant market. Leading trifocal IOLs include the AT.LISA (Carl Zeiss Meditec) and the FineVision (PhysIOL, Liege, Belgium). "They're almost like regular monofocals with an absolute defo- cus curve, good distance, a minimal gap for intermediate, and good near," he said. "The 3 troughs run into each other; people don't com- plain about the rings nearly as much as they do from regular multifocals." What excites Dr. Mamalis about the future of these lenses is that "we're coming up with totally new ways of providing true accommo- dation—a lens that truly changes shape and focus much like our crystalline lens does. "The holy grail is being able to provide clear vision in both eyes; to get an implant that truly does vision in cases of irregular corneal astigmatism and extending depth of focus of normal pseudophakic eyes." It has generated "significant accommodate; and to have an im- plant that gives a wide enough range of focus so people can read, work on a computer, and see distance objects clearly," Dr. Mamalis said. Claudio Trindade, MD, is developing a novel small aperture implant made of black acrylic and implanted in the sulcus that "acts as an intraocular pinhole, improving 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 © 2014 Novartis 10/14 SMB14121JAD 5.6 † mm Hg additional mean diurnal IOP lowering observed 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. † 95% Confidence Interval: -6.23 to -5.06. IOP Daily Time Points (mm Hg) ‡ Treatment Arm 8 am 10 am 3 pm 5 pm PGA + SIMBRINZA ® Suspension (N=88) Baseline § 24.5 22.9 21.7 21.6 Week 6 19.4 15.8 17.2 15.6 PGA + Vehicle (N=94) Baseline § 24.3 22.6 21.3 21.2 Week 6 21.5 20.3 20.0 20.1 ‡ 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) || Treatment Arm PGA + SIMBRINZA ® Suspension (N=88) Baseline ¶ 22.7 Week 6 17.1 PGA + Vehicle (N=94) Baseline ¶ 22.4 Week 6 20.5 || Differences (mm Hg) and P-values at Week 6 between treatment groups were -3.44, P<0.0001. ¶ Baseline (PGA Monotherapy) continued on page 60

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