Comparison of Once-Daily Bromfenac 0.07% Versus Once-Daily Nepafenac 0.3% in Patients Undergoing Phacoemulsification

Melissa M Toyos, Melissa M Toyos

Abstract

Aim: Randomized pilot study comparing clinical outcomes with bromfenac ophthalmic solution 0.07% versus nepafenac 0.3% ophthalmic suspension administered as identical dosing regimens in patients undergoing uncomplicated phacoemulsification with intraocular lens implantation.

Methods: Forty-nine subjects were treated with bromfenac (n = 25) or nepafenac (n = 24) once daily starting 3 days before cataract surgery, continued on the day of surgery, and for 21 days following surgery, in addition to standard of care. Subjects were followed at 1 day and 7, 21, and 42 days postoperatively. Assessments included best-corrected visual acuity [Early Treatment Diabetic Retinopathy Study (ETDRS)], summed ocular inflammation score (SOIS; anterior chamber cells plus flare grading), macular volume and thickness (spectral domain optical coherence tomography), intraocular pressure, and adverse events.

Results: Treatment groups were similar at baseline. Outcomes for mean letters read (p = 0.20), mean change in macular volume (p = 0.98), and retinal thickness (p = 0.93) were not statistically different between the groups at day 42. Mean SOIS dropped markedly and similarly from post-surgical day 1 to day 7 in both treatment groups and was statistically equivalent to baseline in both groups by day 21. At day 42, 87% of subjects in the bromfenac group and 82% of subjects in the nepafenac group demonstrated stable or improved visual acuity. The proportions of eyes with mean retinal thickness of 10 µm or less at days 7, 21, and 42 were similar for the bromfenac (95.8%, 78.3%, 73.9%, respectively) and nepafenac (91.7%, 87.5%, 66.7%) groups (all p = NS, bromfenac vs. nepafenac).

Conclusion: Both bromfenac 0.07% and nepafenac 0.3% produced positive and similar clinical outcomes with regard to ETDRS visual acuity post-cataract surgery when dosed using identical regimens. Increases in mean retinal thickness and mean macular volume were small and similar between treatments.

Trial registration number: NCT01847638.

Funding: Bausch & Lomb Incorporated.

Keywords: Bromfenac; Cataract; Inflammation; Macular volume; NSAIDs; Nepafenac; Phacoemulsification; Retinal thickness; Visual acuity.

Figures

Fig. 1
Fig. 1
Change from baseline in a mean retinal thickness and b mean macular volume at each study timepoint. Study drugs were administered through day 21. Data depict mean ± standard error. No statistically significant differences between treatments at any timepoint
Fig. 2
Fig. 2
Mean SOIS by study visit (see Table 2 for scoring method). Study drugs were administered through day 21. Data depict mean ± standard error. No statistically significant differences between treatments at any timepoint. NS not significant, SOIS summed ocular inflammation score

References

    1. Khairallah M, Kahloun R, Bourne R, et al. Number of people blind or visually impaired by cataract worldwide and in world regions, 1990 to 2010. Invest Ophthalmol Vis Sci. 2015;56(11):6762–6769.
    1. Olson RJ, Braga-Mele R, Chen SH, et al. Cataract in the Adult Eye Preferred Practice Pattern®. Ophthalmology. 2017;124(2):P1–P119.
    1. Lamoureux EL, Fenwicke E, Pesudovs K, Tan D. The impact of cataract surgery on quality of life. Curr Opin Ophthamlmol. 2011;22(1):19–27.
    1. Javed U, McVeigh K, Scott NW, Azuara-Blanco A. Cataract extraction and patient vision-related quality of life: a cohort study. Eye. 2015;29(7):921–925.
    1. Kim SJ, Flach AJ, Jampol LM. Nonsteroidal anti-inflammatory drugs in ophthalmology. Surv Ophthalmol. 2010;55(2):108–133.
    1. Lobo CL, Faria PM, Soares MA, Bernardes RC, Cunha-Vaz JG. Macular alterations after small-incision cataract surgery. J Cataract Refract Surg. 2004;30(4):752–760.
    1. McColgin AZ, Heier JS. Control of intraocular inflammation associated with cataract surgery. Curr Opin Ophthalmol. 2000;11(1):3–6.
    1. Sourdille P, Santiago PY. Optical coherence tomography of macular thickness after cataract surgery. J Cataract Refract Surg. 1999;25(2):256–261.
    1. Wittpenn JR, Silverstein S, Heier J, et al. A randomized, masked comparison of topical ketorolac 0.4% plus steroid vs steroid alone in low-risk cataract surgery patients. Am J Ophthalmol. 2008;146(4):554–60.
    1. Blumenkranz MS, Haller JA, Kuppermann BD, et al. Correlation of visual acuity and macular thickness measured by optical coherence tomography in patients with persistent macular edema. Retina. 2010;30(7):1090–1094.
    1. Flach AJ. The incidence, pathogenesis and treatment of cystoid macular edema following cataract surgery. Trans Am Ophthalmol Soc. 1998;96:557–634.
    1. Juthani VV, Clearfield E, Chuck RS. Non-steroidal anti-inflammatory drugs versus corticosteroids for controlling inflammation after uncomplicated cataract surgery. Cochrane Database Syst Rev. 2017;7:CD010516.
    1. Kessel L, Tendal B, Jørgensen KJ, et al. Post-cataract prevention of inflammation and macular edema by steroid and nonsteroidal anti-inflammatory eye drops: a systematic review. Ophthalmology. 2014;121(10):1915–1924.
    1. Kida T, Ogawa T, McNamara TR, Song CK, Gow JA. Evaluation of the human COX-2 inhibition of amfenac, bromfenac, diclofenac, and ketorolac. Paper presented at American Society of Cataract and Refractive Surgery Symposium on Cataract, IOL, and Refractive Surgery; April 27–May 2, 2007. San Diego; 2007.
    1. Waterbury LD, Silliman D, Jolas T. Comparison of cyclooxygenase inhibitory activity and ocular anti-inflammatory effects of ketorolac tromethamine and bromfenac sodium. Curr Med Res Opin. 2006;22(6):1133–1140.
    1. Walters T, Raizman M, Ernest P, Gayton J, Lehmann R. In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac. J Cataract Refract Surg. 2007;33(9):1539–1545.
    1. Sheppard JD. Topical bromfenac for prevention and treatment of cystoid macular edema following cataract surgery: a review. Clin Ophthalmol. 2016;10:2099–2111.
    1. Prolensa® (bromfenac ophthalmic solution) 0.07% [prescribing information]. Bausch + Lomb, a division of Valeant Pharmaceuticals North America, LLC, Rochester, MN; 2016.
    1. Modi SS, Lehmann RP, Walters TR, et al. Once-daily nepafenac ophthalmic suspension 0.3% to prevent and treat ocular inflammation and pain after cataract surgery: phase 3 study. J Cataract Refract Surg. 2014;40(2):203–11.
    1. Donnenfeld ED, Holland EJ, Stewart RH, Gow JA, Grillone LR, on behalf of the Bromfenac Ophthalmic Solution 0.09% (Xibrom) Study Group Bromfenac ophthalmic solution 0.09% (Xibrom) for postoperative ocular pain and inflammation. Ophthalmology. 2007;114(9):1653–1662.
    1. Silverstein SM, Cable MG, Sadri E, et al. Once daily dosing of bromfenac ophthalmic solution 0.09% for postoperative ocular inflammation and pain. Curr Med Res Opin. 2011;27(9):1693–703.
    1. Nardi M, Lobo C, Bereczki A, et al. Analgesic and anti-inflammatory effectiveness of nepafenac 0.1% for cataract surgery. Clin Ophthalmol. 2007;1(4):527–33.
    1. Lane SS, Modi SS, Lehmann RP, Holland EJ. Nepafenac ophthalmic suspension 0.1% for the prevention and treatment of ocular inflammation associated with cataract surgery. J Cataract Refract Surg. 2007;33(1):53–8.
    1. Ilevro® (nepafenac ophthalmic suspension) 0.3% [prescribing information]. Alcon Laboratories. Fort Worth, TX; 2014.
    1. Cable M. Comparison of bromfenac 0.09% QD to nepafenac 0.1% tid after cataract surgery: pilot evaluation of visual acuity, macular volume, and retinal thickness at a single site. Clin Ophthalmol. 2012;6:997–1004.
    1. Kaiser PK. Prospective evaluation of visual acuity assessment: a comparison of Snellen versus ETDRS charts in clinical practice (an OAS thesis) Trans Am Ophthalmol Soc. 2009;107:311–324.
    1. Miyanaga M, Miyai T, Nejima R, Maruyama Y, Miyata K, Kato S. Effect of bromfenac ophthalmic solution on ocular inflammation following cataract surgery. Acta Ophthalmol. 2009;87(3):300–305.
    1. Miyake K, Ota I, Miyake G, Numaga J. Nepafenac 0.1% verus fluorometholone 0.1% for preventing cystoid macular edema after cataract surgery. J Cataract Refract Surg. 2011;37(9):1581–8.

Source: PubMed

3
Prenumerera