Bromfenac ophthalmic solution for the treatment of postoperative ocular pain and inflammation: safety, efficacy, and patient adherence

Rajesh K Rajpal, Bryan Ross, Sachin D Rajpal, Khoa Hoang, Rajesh K Rajpal, Bryan Ross, Sachin D Rajpal, Khoa Hoang

Abstract

Ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used by clinicians to manage ocular inflammation and pain following cataract surgery. Over the past decade, the US Food and Drug Administration has approved multiple topical NSAIDs for these purposes, including several reformulated products. One of these medications, bromfenac ophthalmic solution, has a long and extensive history, with proven efficacy and safety in patients following cataract surgery. The evolution of bromfenac ophthalmic solution over the years has involved either lowering the concentration of the active ingredient or extending the dosing interval to improve patient adherence/compliance. This review will focus on the history and progression of bromfenac ophthalmic solution and report the available patient preference and adherence data regarding this ocular NSAID throughout its evolution.

Keywords: COX inhibitors; cataract surgery; nonsteroidal anti-inflammatory drugs.

References

    1. Groessl EJ, Liu L, Sklar M, Tally SR, Kaplan RM, Ganiats TG. Measuring the impact of cataract surgery on generic and vision-specific quality of life. Qual Life Res. 2013;22(6):1405–1414.
    1. Buch H, Vinding T, La Cour M, Appleyard M, Jensen GB, Nielsen NV. Prevalence and causes of visual impairment and blindness among 9980 Scandinavian adults: the Copenhagen City Eye Study. Ophthalmology. 2004;111(1):53–61.
    1. Vision 2020: the cataract challenge. Community Eye Health. 2000;13(34):17–19. [no authors listed]
    1. Congdon N, O’Colmain B, Klaver CC, et al. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004;122(4):477–485.
    1. Monnet D, Tépenier L, Brézin AP. Objective assessment of inflammation after cataract surgery: comparison of 3 similar intraocular lens models. J Cataract Refract Surg. 2009;35(4):677–681.
    1. Prolensa [package insert] Tampa, FL: Bausch and Lomb Inc; 2013.
    1. [homepage on the Internet] Nevanac (nepafenac) European Medicines Agency; 2014. [Accessed March 25, 2014]. [updated September 18, 2013]. Available from: .
    1. Ilevro [package insert] Fort Worth, TX: Alcon Laboratories Inc; 2013.
    1. Donnenfeld ED, Perry HD, Wittpenn JR, Solomon R, Nattis A, Chou T. Preoperative ketorolac tromethamine 0.4% in phacoemulsification outcomes: pharmacokinetic-response curve. J Cataract Refract Surg. 2006;32(9):1474–1482.
    1. American Academy of Ophthalmology Cataract and Anterior Segment Panel . Preferred Practice Patterns: Cataract in the Adult Eye. San Francisco: American Academy of Ophthalmology; 2011.
    1. Warner TD, Mitchell JA. Cyclooxygenases: new forms, new inhibitors, and lessons from the clinic. FASEB J. 2004;18(7):790–804.
    1. Findl O. Redefining the treatment paradigm for post-operative inflammation control – the role of topical non-steroidal anti-inflammatory drugs. Euro Ophthalmol Rev. 2010;4(1):54–59.
    1. Colin J. The role of NSAIDs in the management of postoperative ophthalmic inflammation. Drugs. 2007;67(9):1291–1308.
    1. Csukas S, Paterson CA, Brown K, Bhattacherjee P. Time course of rabbit ocular inflammatory response and mediator release after intravitreal endotoxin. Invest Ophthalmol Vis Sci. 1990;31(2):382–387.
    1. Koay P. The emerging roles of topical non-steroidal anti-inflammatory agents in ophthalmology. Br J Ophthalmol. 1996;80(5):480–485.
    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. Renfro L, Snow JS. Ocular effects of topical and systemic steroids. Dermatol Clin. 1992;10(3):505–512.
    1. Becker B. The side effects of corticosteroids. Invest Ophthalmol. 1964;3(5):492–497.
    1. McGhee CN. Pharmacokinetics of ophthalmic corticosteroids. Br J Ophthalmol. 1992;76(11):681–684.
    1. Bartlett JD, Horwitz B, Laibovitz R, Howes JF. Intraocular pressure response to loteprednol etabonate in known steroid responders. J Ocul Pharmacol. 1993;9(2):157–165.
    1. O’Brien TP. Emerging guidelines for use of NSAID therapy to optimize cataract surgery patient care. Curr Med Res Opin. 2005;21(7):1131–1137.
    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. Endo N, Kato S, Haruyama K, Shoji M, Kitano S. Efficacy of bromfenac sodium ophthalmic solution in preventing cystoid macular oedema after cataract surgery in patients with diabetes. Acta Ophthalmol. 2010;88(8):896–900.
    1. Warren KA, Bahrani H, Fox JE. NSAIDs in combination therapy for the treatment of chronic pseudophakic cystoid macular edema. Retina. 2010;30(2):260–266.
    1. Singh R, Alpern L, Jaffe GJ, et al. Evaluation of nepafenac in prevention of macular edema following cataract surgery in patients with diabetic retinopathy. Clin Ophthalmol. 2012;6:1259–1269.
    1. Wang QW, Yao K, Xu W, et al. Bromfenac sodium 0.1%, fluorometholone 0.1% and dexamethasone 0.1% for control of ocular inflammation and prevention of cystoid macular edema after phacoemulsification. Ophthalmologica. 2013;229(4):187–194.
    1. Ahuja M, Dhake AS, Sharma SK, Majumdar DK. Topical ocular delivery of NSAIDs. AAPS J. 2008;10(2):229–241.
    1. Cho H, Wolf KJ, Wolf EJ. Management of ocular inflammation and pain following cataract surgery: focus on bromfenac ophthalmic solution. Clin Ophthalmol. 2009;3:199–210.
    1. Donnenfeld ED, Holland EJ, Stewart RH, Gow JA, Grillone LR. Bromfenac ophthalmic solution 0.09% (Xibrom) for postoperative ocular pain and inflammation. Ophthalmology. 2007;114(9):1653–1662.
    1. Henderson BA, Gayton JL, Chandler SP, Gow JA, Klier SM, McNamara TR. Safety and efficacy of bromfenac ophthalmic solution (Bromday) dosed once daily for postoperative ocular inflammation and pain. Ophthalmology. 2011;118(11):2120–2127.
    1. Ridgway D. Analgesics for acute pain: meeting the United States Food and Drug Administration’s requirements for proof of efficacy. Clin J Pain. 2004;20(3):123–132.
    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):1693–1703.
    1. Miyake K, Ogawa T, Tajika T, Gow JA, McNamara TR. Ocular pharmacokinetics of a single dose of bromfenac sodium ophthalmic solution 0.1% in human aqueous humor. J Ocul Pharmacol Ther. 2008;24(6):573–578.
    1. Mukai K, Matsushima H, Gotoh N, et al. Efficacy of ophthalmic nonsteroidal anti-inflammatory drugs in suppressing anterior capsule contraction and secondary posterior capsule opacification. J Cataract Refract Surg. 2009;35(9):1614–1618.
    1. Bromday [package insert] Irvine, CA: ISTA Pharmaceuticals, Inc; 2011.
    1. Brown HB, Taylor P. Muscarinic receptor agonists and antagonists. In: Hardman JG, Limbird LE, Molinoff PB, Ruddon RW, editors. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 9th ed. New York: McGraw-Hill; 1996.
    1. Sancilio LF, Nolan JC, Wagner LE, Ward JW. The analgesic and anti-inflammatory activity and pharmacologic properties of bromfenac. Arzneimittelforschung. 1987;37(5):513–519.
    1. Walsh DA, Moran HW, Shamblee DA, et al. Anti-inflammatory agents. 3. Synthesis and pharmacological evaluation of 2-amino-3-benzoylphenylacetic acid and analogues. J Med Chem. 1984;27(11):1379–1388.
    1. Kida T, Ogawa T, McNamara TR, et al. Evaluation of the Human COX-2 Inhibition of Amfenac, Bromfenac, Diclofenac, and Ketorolac. San Diego: American Society of Cataract and Refractive Surgery; 2007.
    1. Ruiz J, López M, Milà J, Lozoya E, Lozano JJ, Pouplana R. QSAR and conformational analysis of the anti-inflammatory agent amfenac and analogues. J Comput Aided Mol Des. 1993;7(2):183–198.
    1. Baklayan GA, Patterson HM, Song CK, Gow JA, McNamara TR. 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(4):392–398.
    1. Bronuck [package insert] Osaka, Japan: Senju Pharmaceutical Co; 2009.
    1. Xibrom [package insert] Irvine, CA: ISTA Pharmaceuticals, Inc; 2010.
    1. Walters TR, Goldberg DF, Peace JH, Gow JA. Bromfenac ophthalmic solution 0.07% dosed once daily for cataract surgery: results of 2 randomized controlled trials. Ophthalmology. 2014;121(1):25–33.
    1. Gow JA, Boyce JD, Reiser HJ, Berry R, Dao JT, Chandler SP. Randomized, placebo-controlled, integrated phase III clinical trials of a once daily, low-concentration, modified bromfenac ophthalmic solution following cataract surgery: focus on zero to trace anterior chamber inflammation; Poster presented at: Annual Meeting of the Association for Research in Vision and Ophthalmology; May 5; 2013; Seattle, WA.
    1. Jones J, Francis P. Ophthalmic utility of topical bromfenac, a twice-daily nonsteroidal anti-inflammatory agent. Expert Opin Pharmacother. 2009;10(14):2379–2385.
    1. Donnenfeld ED, Donnenfeld A. Global experience with Xibrom (bromfenac ophthalmic solution) 0.09%: the first twice-daily ophthalmic nonsteroidal anti-inflammatory drug. Int Ophthalmol Clin. 2006;46(4):21–40.
    1. Duong HQ, Westfield KC, Singleton IC. Comparing the efficacy of bromfenac 0.09% and nepafenac 0.1% post cataract surgery: a prospective evaluation. J Clinic Experiment Ophthalmol. 2011;2(8):177.
    1. Okeke CO, Quigley HA, Jampel HD, et al. Adherence with topical glaucoma medication monitored electronically the Travatan Dosing Aid study. Ophthalmology. 2009;116(2):191–199.
    1. Richter A, Anton SE, Koch P, Dennett SL. The impact of reducing dose frequency on health outcomes. Clin Ther. 2003;25(8):2307–2335.
    1. Tsai T, Robin AL, Smith JP., 3rd An evaluation of how glaucoma patients use topical medications: a pilot study. Trans Am Ophthalmol Soc. 2007;105:29–33.
    1. Robin AL, Novack GD, Covert DW, Crockett RS, Marcic TS. Adherence in glaucoma: objective measurements of once-daily and adjunctive medication use. Am J Ophthalmol. 2007;144(4):533–540.
    1. Heaney L, Hicks W, Seeruthun R. Adherence in Asthma: Comparing Clinical Trials to the “Real World.”. Pharmaceutical Product Development, LLC; 2013. [Accessed May 14, 2014]. Available from: .
    1. Ichimaru N, Kakuta Y, Abe T, et al. Treatment adherence in renal transplant recipients: a questionnaire survey on immunosuppressants. Transplant Proc. 2008;40(5):1362–1365.
    1. Hauber AB, Han S, Yang JC, et al. Effect of pill burden on dosing preferences, willingness to pay, and likely adherence among patients with type 2 diabetes. Patient Prefer Adherence. 2013;7:937–949.
    1. Bock O, Felsenberg D. Biphosphonates in the management of postmenopausal osteoporosis – optimizing efficacy in clinical practice. Clin Interventions Aging. 2008;3(2):279–297.

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