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EW AUG 2012 - Supported by ISTA Pharmaceuticals

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"I believe I could always add a steroid if I need to," he said. Dr. Walter used this protocol on all his patients, and he recently published data from his experience in U.S. Ophthalmic Review. 1 In this study, Dr. Walter and his colleagues looked retrospectively at 200 consecutive eyes in which he had used Pred Forte 1% four times a day for about 5 weeks. About 12% of those patients received Bromday as well. They also looked at 200 consecutive eyes where he only used Bromday; none of those patients had supplemental steroids. Dr. Walter performed surgery on most of the eyes, leaving about 20% to two different fellows. They included "all comers"—their patients with diabetes, floppy iris, and hard nuclei. They looked at pain, inflammation, BCVA, CME, and post-op IOP as endpoints. They had follow-up in 178 eyes with Pred Forte and 169 eyes with Bromday. The vision between the two groups of patients was about the same, with BCVA 1 month post-op at 20/27.2 and 20/26.6, respectively. At 2 weeks post-op, inflammation was seen in 16 (8%) Pred Forte group eyes and 24 (12%) Bromday eyes. Of note, Dr. Walter said that two out of the 24 eyes in the Bromday group had retained nuclear fragments. They had 44 patients respond to a survey. These patients rated pain 4 August 2012 Anti-inflammation: Perfecting cataract surgery intraoperatively and post-op at around 1 on a scale from 0 to 10, indicating very low pain either intra- or post-op. Only 2 (1%) eyes in the Pred Forte group and 1 (0.5%) in the Bromday group had CME, detected clinically and confirmed with OCT. IOP elevation proved to be an interest- ing endpoint, said Dr. Walter. The total number of eyes with IOP elevations of 5 mm Hg or higher from pre-op baseline was 16 (8%) in the Pred Forte group and 7 (3.5%) in the Bromday group (p=0.08). Note that the eyes with elevated IOP in the Bromday group included the two eyes with retained nuclear fragments. Looking at eyes with a history of glaucoma, 8 out of 25 (32%) in the Pred Forte group and none out of 17 in the Bromday group had IOP elevation. Remember that these are all comers, including patients with floppy irises, diabetes, and dense nuclei. "Why haven't we needed to add a steroid in any of my last 900 cases [including the 200 who were part of this study]?" wondered Dr. Walter. "I think it comes down to this: It may be that we are so engrained to use a steroid that it's impossible to consider doing otherwise in these cases," he said. It must also have to do with the advances in pharmaceutical technology. "NSAIDs have gotten better and better with each additional newcomer on the block," said Dr. Walter. "Bromday is a better NSAID than any we've had before. "It's made my life simpler because now my patients have a much simpler drop table," he continued. "Compliant patients have had no CME yet, and we have not had any corneal complications." Reference 1. Walter K, Estes A, Watson S, Ellingboe M. Management of Ocular Inflammation following Routine Cataract Surgery—Topical Corticosteroid (Prednisolone) versus Topical Non-steroidal (Bromfenac). US Ophthalmic Review, 2011;4(2):97-100. 2. Duong HQ, Westfield KC, Singleton IC. Comparing Three Post-Op Regiments for Management of Inflammation Post Uncomplicated Cataract Surgery. "Are Steroids Really Necessary?" J Clinic Experiment Ophthalmol 2011; 2:6. 3. Cable M. Clinical Outcomes of Bromfenac Ophthalmic Solution 0.09% QD vs. Nepafenac 0.1% TID for Treatment of Ocular Inflammation Associated with Ocular Surgery. Presented at ARVO 2012. Contact information Devgan: devgan@gmail.com Gayton: JLGayton@aol.com Katsev: katsev@aol.com Kim: terry.kim@duke.edu Walter: kwalter@wfubmc.edu steroid vs. steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008;146:554-560. 9. Asano S, Miyake K, Ota I, et al. Reducing angiographic cystoid macular edema and blood-aqueous barrier disruption after small-incision phacoemulsification and foldable intraocular lens implantation: Multicenter prospective randomized comparison of topical diclofenac 0.1% and betamethasone 0.1%. J Cataract Refract Surg. 2008;34(1):57-63. 10. Baklayan GA, Patterson HM, Song CK, et al. 24-hour evaluation of the ocular distribution of (14) c-labeled bromfenac following topical instillation into the eyes of New Zealand white rabbits. J Ocul Pharmacol Ther. 2008;24:392-398. 11. Data on file, ISTA Pharmaceuticals. NSAID alone vs. NSAID + steroid Are steroids really necessary in routine cataract surgery? asked Dr. Walter. In October 2010, he said that steroids stopped being a routine part of his cataract kits. "At the time, I was frustrated by how ineffective generic steroids were, and I was hesitant to write a prescription for yet another eye drop," he said. Since then, Dr. Walter said that he only uses Bromday. He begins therapy 2 days before surgery and has the patient use it until the bottle runs out, an off- label—but effective, in his experience— use of the drug. This supplement was produced by EyeWorld and supported by an educational grant from ISTA Pharmaceuticals. Copyright 2012 ASCRS Ophthalmic Corporation. All rights reserved. The views expressed here do not necessarily reflect those of the editor, editorial board, or the publisher and in no way imply endorsement by EyeWorld or ASCRS. IOP proved to be an interesting endpoint for Dr. Walter, with significantly more eyes experiencing IOP elevation with Pred Forte than with Bromday ISTA supplement_EW August 2012-DL_Layout 1 6/3/14 2:36 PM Page 1

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