Prospective, Randomized, Double-Blind Study Comparing Nepafenac 0.1% (Nevanac™) and Bromfenac Sodium 0.09% (Xibrom™) in Post-Op Cataract Patients Hon-Vu Q. Duong, M.D. 1,2 Kenneth C. Westfield, M.D., M.B.A. 1 Isaac C. Singleton, O.D. 1 None of the authors have any financial interests nor was the study supported by any unrestricted grant from government or non government agencies.

Abstract Purpose – To objectively compared two FDA approved NSAIDs in post-operative cataract patients Design – Prospective, randomized, double-blind study conducted at a single center, private practice in Las Vegas, Nevada – Two end points were measured Is OCT sensitive in detecting early or subclinical cystoid macular edema Incidence of CME between nepafenac 0.1% and bromfenac 0.09%

Abstract Methods – IRB approved – Patients were randomized into two groups Group #1: bromfenac sodium 0.09% + prednisolone acetate 1% + moxifloxicin hydrochloride 0.5% (N=88) Group #2: nepafenac 0.1% + prednisolone acetate 1% + moxifloxicin hydrochloride 0.5% (N=85) Pre-operative evaluation and measured values included: best corrected visual acuity (Va), intraocular pressure by applanation (IOP), anterior and posterior segment evaluation, and baseline OCT All surgeries were performed by one surgeon (KCW), all post op evaluations were performed by one doctor of optometry (ICS)

Abstract Results Variables measured were not statistically significant with the p-value > 0.05 at baseline and on post-op day(s) 1, 7, & 30. Three patients in each group had clinically significant macular edema and all were followed with serial OCT3 scans. Thirteen patients in the nepafenac group and 14 patients in the bromfenac group were noted to have subclinical macular edema based on OCT findings. OCT was also sensitive in detecting subclinical macular edema in four patients with non-proliferative diabetic retinopathy; two patients in each group respectively. Conclusions Both NSAIDs have shown to be efficacious with no statistically significant differences in post-operative cataract care. OCT3 was more sensitive in detecting early macular edema than clinical examination.

Demographic BromfenacNepafenacBromfenacNepafenac Total Enrolled103102Comorbidities Completed8885Diabetic29 (33%)30 (35.3%) Lost to F/U1517ARMD19 (21.6%)22 (25.9%) Average Age69.39 ± ±9.28POAG21 (23.9%)24 (28.2%) Age Range GS/OHTN11 (12.5%)9 (10.6%) SexERM2 (2.27%)2 (2.35%) Male38 (43.2%)49 (57.6%)Other14 (15.9%)12 (14.1%) Female50 (56.8%)36 (42.4%) Eyes OD52 (59.1%)43 (50.6%) OS36 (40.9%)42 (49.4%) ARMD = age-related macular edema POAG = primary open angle glaucoma GS/OHTN = glaucoma suspect/ocular hypertension ERM = epiretinal membrane

Visual Acuity and Mean IOP BaselinePOD #1POD #7POD #30 Visual Acuity in Log MAR ± SD Bromfenac0.63 ± ± ± ± 0.21 Nepafenac0.54 ± ± ± ± 0.2 Statistical Value (p < 0.05)p = 0.23p = 0.38p = 0.06 Mean IOP in mmHg ± SD Bromfenac16.25 ± ± ± ± 2.58 Nepafenac16.19 ± ± ± ± 2.87 Statistical Value (p < 0.05)p = 0.39p = 0.23p = 0.44 POD = post-operative day

Foveal & Central Foveal Thickness Total PatientFT BaselineFT 1-weekCFT BaselineCFT 1-week Bromfenac (N = 88) ± ± ± ± Nepafenac (N = 85) ± ± ± ± p < 0.05p = 0.30p = 0.25p = 0.07p = 0.08 DiabeticFT BaselineFT 1-weekCFT BaselineCFT 1-week Bromfenac (N = 29) ± ± ± ± Nepafenac (N = 30) ± ± ± ± p < 0.05p = 0.19p = 0.38p = 0.14p = FT = foveal thickness in micrometer: the mean thickness within the central 1000 micron diameter area of the fovea. 4 CFT = central foveal thickness in micrometer: the mean thickness measured at the point of intersection of the six radial scans by OCT. 4

Incidence of Cystoid Macular Edema CME by OCTFT BaselineFT 1-weekCFT BaselineCFT 1-week Bromfenac (N = 14) ± ± ± ± 7.54 Nepafenac N = 13) ± ± ± ± p-value (p < 0.05)P = 0.68P = 0.29P = 0.11P = FT = foveal thickness; CFT = central foveal thickness CME = cystoid macular edema OCT = optical coherency tomography

Discussion/Conclusion Cystoid macular edema (CME) was determined both clinically as well as by OCT3. In our study, CME by OCT was defined: foveal and central foveal thickness 2 SD outside the mean In our study, OCT3 was highly sensitive in diagnosing early subclinical CME. – Incidence of CME (clinically) was not statistically significant between the two topical NSAIDs. – Incidence of CME by OCT based on CFT was statistically significant. However, OCT base FT was not statistically significant. – Incidence of CME in diabetics (clinically and by OCT) was not statistically significant between the two topical NSAIDs.

Discussion/Conclusion Both topical NSAIDs performed reliably well throughout the study period. – High degree of compliances during the study period based on patient reporting No statistical significant differences in all the parameters measured between bromfenac and nepafenac. Both topical NSAIDs are efficacious their purported pharmacological properties.

References 1.Almeida D., Johnson D., Hollands H., et al. Effect of prophylactic nonsteroidal antiinflammatory drugs on cystoid macular edema assessed using optical coherence tomography quantification of total macular volume after cataract surgery. J Cataract Refract Surg, 2008;34: Brown J., Solomon S., Bressler S., et al. Detection of Diabetic Foveal Edema. Arch Ophthalmol. 2004;122: Polito A., Del Borrello M., Isola M., et al., Repeatability and Reproducibility of Fast Macular Thickness Mapping With Stratus Optical Coherence Tomography. Arch Ophthalmol. 2005;123: Chan A., Duker J., Ko T., et al., Normal Macular Thickness Measurements in Healthy Eyes Using Stratus Coherence Tomography. Arch Ophthalmol. 2006;124: Pires I., Bernardes R., Lobo C., et al., Retinal Thickness in Eyes With Mild Nonproliferative Retinopathy in Patients With Type 2 Diabetes Mellitus. – Comparison of Measurements Obtained by Retinal Thickness Analysis and Optical Coherence Tomography, Arch Ophthalmology 2002;120: Thomson, Physicians’ Desk Reference – 2008, 7.Ista Laboratories, Package Insert, Xibrom. Affiliations – 1. Westfield Eye Center, 2575 Lindell Road, Las Vegas, NV – 2. Nevada State College, 1125 Nevada State Drive, Henderson, NV Contact – Hon-Vu Q. Duong, M.D., 2575 Lindell Road, Las Vegas, NV 89146,