Bromfenac in ophthalmic practice
DOI: 10.32364/2311-7729-2021-21-4-241-248
M.L. Maksimov1,2,3, A.A. Zvegintseva1,4, I.D. Kanner5, N.M. Lapkin6
1Kazan State Medical Academy — Branch of the Russian Medical Academy of Continuous Professional Education, Kazan, Russian Federation
2Russian Medical Academy of Continuous Professional Education, Moscow,
Russian Federation
3Pirogov Russian National Research Medical University, Moscow, Russian Federation
4Republican Clinical Hospital of the Ministry of Health of the Republic of Tatarstan,
Kazan, Russian Federation
5Lomonosov Moscow State University, Moscow, Russian Federation
6Yaroslavl State Medical University, Yaroslavl, Russian Federation
Non-steroidal anti-inflammatory drugs (NSAIDs) are essential for the treatment of ocular disorders. While corticosteroids are the gold standard for inflammatory ocular diseases, comparative studies on the efficacy of NSAIDs and corticosteroids have demonstrated no significant differences in outcomes. Given the chemical structure of NSAIDs, it should be noted that salicylates, phenamates, and pyrazoline derivatives are either toxic or unstable. Solubilizers and preservatives also account for toxicity. Bromfenac-based medications are characterized by high safety and contain minimum benzalkonium chloride.
This paper reviews advantages of a modern topical NSAID, bromfenac, for ocular use. This medication is more effective than diclofenac (by 3.7 times), amfenac (by 6.5 times), and ketorolac (by 18 times) in terms of inhibiting COG-2. Furthermore, the regimen of use (twice daily), no discomfort, and excellent safety profile with minimal adverse effects improve treatment adheren ce. In addition, Bromfenac, a topical anti-inflammatory agent, improves patients’ satisfaction with surgical outcomes since patients achieve maximum possible visual acuity as early as possible.
Keywords: non-steroidal anti-inflammatory drugs, NSAIDs, bromfenac, arachidonic acid, inflammation, corticosteroids, eye surgery, cataract, cystoid macular edema.
For citation: Maksimov M.L., Zvegintseva A.A., Kanner I.D., Lapkin N.M. Bromfenac in ophthalmic practice. Russian Journal of Clinical Ophthalmology. 2021;21(4):241–248 (in Russ.). DOI: 10.32364/2311-7729-2021-21-4-241-248.
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20. Donnenfeld E.D., 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. DOI: 10.1097/01.iio.0000212134.83513.11.
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22. Walters T., Raizman M., Ernest P. et al. In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac. J Cataract Refract Surg. 2007;33(9):1539–1545. DOI: 10.1016/j.jcrs.2007.05.015.
23. Ahuja M., Dhake A.S., Sharma S.K. et al. Topical ocular delivery of NSAIDs. AAPS J. 2008;10(2):229–241. DOI: 10.1208/s12248-008-9024-9.
24. Ogawa T., Miyake K., McNamara T.R. et al. Pharmacokinetic profile of topically applied bromfenac sodium ophthalmic sodium ophthalmic solution 0.1% in subjects undergoing cataract surgery. Proceedings of the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, Ft. Lauderdale, FL, April 30–May 4, 2006. A687.
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31. Behndig A., Lundberg B.J. Transient corneal edema after phacoemulsification: comparison of 3 viscoelastic regimens. J. Cataract Refract. Surg. 2002;28(9):1551–1556. DOI: 10.1016/s0886-3350(01)01219-6.
32. Behndig A., Lundberg B.J. Mydriatic response to different concentrations of intracameral phenylephrine in humans. J. Cataract Refract. Surg. 2010;36(10):1682–1686. DOI: 10.1016/j.jcrs.2010.04.036.
33. Lebraud P., Adenis J.P., Franco J.L. et al. Cystoid macular edema of pseudophakic patients (retrospective study with 300 pseudophakic patients). Bull. Soc. Ophthalmol. Fr. 1987;87(12):1437–1439.
34. Mentes J., Erakgun T., Afrashi F., Kerci G. Incidence of cystoids macular edema after uncomplicated phacoemulsification. Ophthalmologica. 2003;217(6):408–412. DOI: 10.1159/000073070.
35. Henderson B.A., Pineda R. Essentials of cataract surgery. Slack. Inc. 2007:187–200.
36. Gross J. Xibrom (bromfenac) reduces macular edema associated with vien occlu- sion, macular epiretinal membrane, diabetic retinopathy and age related macular degeneration. Poster F-3, 40th Meeting of thr Retina Society, Boston; 2007.
37. Silverstein S.M., Jackson M.A., Goldberg D.F., Muñoz M. The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zeroto-trace anterior chamber cell severity following cataract surgery. Clin. Ophthalmol. 2014;8:965–972. DOI: 10.2147/OPTH.S60292.
38. Song S.H. Effect of 0.1% Bromfenac for Preventing Macular Edema after Cataract Surgery in Patients with Diabetes. Korean Journal of Ophthalmology. 2020;34(1):46–55. DOI: 10.3341/kjo.2019.0044.
39. Rho D.S., Soll S.M., Markovitz B.J. Bromfenac 0,09% versus diclofenac sodium 0,1% versus ketorolac tromethamine 0,5% in the treatment of acute pseudophakic cys- toid macular edema. Invest.Ophthalmol. Vis. Sci. 2006;47.
40. Donnenfeld E.D., Holland E.J., Stewart R. et al. Topical Xibrom 0,1% an investigational NSAID, significantlyand rapidly decreased post-cataract surgery inflammation and reduced ocular pain. Invest. Ophthalmol. Vis. Sci. 2005;46(E-abstract 791).
41. Cable M. Clinical outcomes of BROMDAY Versus Nepafenac, Presented at: Annual Meeting of American Siciety of Retinal Specialists, Boston, 2011.
42. Ohara K., Ohkubo A., Miyamoto T. Prevention of miosis during cataract surgery by topical bromfenac sodium. Rinsho Ganka (Jpn J Clin Ophthalmol). 2004;58:1325–1328.
43. Ocular NSAIDs: a new option. Insert. to Cataract and Refractive Surgery Today. 2006:8.
44. Usui M., Masuda K. Effect of bromfenac sodium (AHR-10282B) eye drops on anterior uveitis. Ganka Rinsho Iho (J Rev Clin Ophthalmol). 1997;91:39–44.
45. Ocular Surgery News: Ista announces positive results from phase 2 trial of low- dose bromfenac in dry eye disease. 2009.
46. Schechter B.A. Ketorolac during the induction phase of cyclosporin-A therapy J. Ocular. Pharmacol. Ther. 2006;22(2):150–154. DOI: 10.1089/jop.2006.22.150.
47. Miyake-Kashima M., Takano Y., Tanaka M. et al. Comparision of 0.1% bromfenac sodium and 0.1% pemirolast potassium for the treatment of allergic conjunctivitis. Jpn. J. Ophthalmol. 2004;48:587–590. DOI: 10.1007/s10384-004-0127-2.
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49. Grant C.A. Combination therapy: lucentis (ranibizumab injection) and xibrom (bromfenac ophthalmic solution) 0.09% in the treatment of choroidal neovascular membrane secondary to age-related macular degeneration. Invest. Ophthalmol. Vis. Sci. 2008;49(E-Abstract 563).
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2. McGhee C.N., Dean S., Danesh-Meyer H. Locally administered ocular corticosteroids: benefits and risks. Drug Saf. 2002;25:33–55. DOI: 10.2165/00002018-200225010-00004.
3. Flach A.J. Topical nonsteroidal anti-inflammatory drugs in ophthalmology. Int Ophthalmol Clin. 2002;42:1–11. DOI: 10.1097/00004397-200201000-00003.
4. 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;34:57–63. DOI: 10.1016/j.jcrs.2007.08.030.
5. Wolf E.J., Braunstein A., Shih C. et al. Incidence of visually significant pseudophakic macular edema after uneventful phacoemulsification in patients treated with nepafenac. J Cataract Refract Surg. 2007;33:1546–1549. DOI: 10.1016/j.jcrs.2007.05.018.
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7. Modjtahedi B.S., Paschal J.F., Batech M. et al. Perioperative topical nonsteroidal anti-inflammatory drugs for macular edema prophylaxis following cataract surgery. Am. J. Ophthalmol. 2017;176:174–182. DOI: 10.1016/j.ajo.2017.01.006.
8. Kim S.J., Schoenberger S.D., Thorne J.E. et al. Topical nonsteroidal anti-inflammatory drugs and cataract surgery: a report by the American Academy of Ophthalmology. Ophthalmology. 2015;122(11):2159–2168. DOI: 10.1016/j.ophtha.2015.05.014.
9. Кукес В.Г. и др. Клиническая фармакология: учебник. 6-е изд., испр. и доп. М.: ГЕОТАР-Медиа; 2018. [Kukes V.G. et al. Clinical pharmacology: textbook. 6th ed. amended and supplemental. M.: GEOTAR-Media; 2018 (in Russ.)].
10. Максимов М.Л., Бонцевич Р.А., Бурашникова И.С. и др. Клиническая фармакология и рациональная фармакотерапия для практикующих врачей. Казань: ИД «МеДДоК»; 2021. [Maksimov M.L., Boncevich R.A., Burashnikova I.S. et al. Clinical pharmacology and rational pharmacotherapy for medical practitioner: textbook. Kazan: "MEDDoK" Publishing House; 2021 (in Russ.)].
11. Bacchi S., Palumbo P., Sponta A. et al. Clinical pharmacology of non-steroidal antiinflammatory drugs: a review. Antiinflamm Antiallergy Agents Med Chem. 2012;11(1):52–64. DOI: 10.2174/187152312803476255.
12. Hanna V.S., Hafez E.A.A. Synopsis of arachidonic acid metabolism: A review. J Adv Res. 2018;11:23–32. DOI: 10.1016/j.jare.2018.03.005.
13. Poorani R., Bhatt A.N., Dwarakanath B.S. et al. COX-2, aspirin and metabolism of arachidonic, eicosapentaenoic and docosahexaenoic acids and their physiological and clinical significance. Eur J Pharmacol. 2016;785:116–132. DOI: 10.1016/j.ejphar.2015.08.049.
14. Simmons D.L., Botting R.M., Hla T. Cyclooxygenase isozymes: the biology of prostaglandin synthesis and inhibition. Pharmacol Rev. 2004;56(3):387–437. DOI: 10.1124/pr.56.3.3.
15. Doucette L.P., Walter M.A. Prostaglandins in the eye: Function, expression, and roles in glaucoma. Ophthalmic Genet. 2017;38(2):108–116. DOI: 10.3109/13816810.2016.1164193.
16. Bhattacherjee P. Prostaglandins and inflammatory reactions in the eye. Methods Find Exp Clin Pharmacol. 1980;2(1):17–31.
17. Kandarakis S.A., Petrou P., Papakonstantinou E. et al. Ocular nonsteroidal inflammatory drugs: where do we stand today? Cutan Ocul Toxicol. 2020;39(3):200–212. DOI: 10.1080/15569527.2020.1760876.
18. Flach A.J. Topical nonsteroidal antiinflammatory drugs in ophthalmology. Int Ophthalmol Clin. 2002;42(1):1–11. DOI: 10.1097/00004397-200201000-00003.
19. Wilson D.J., Schutte S.M., Abel S.R. Comparing the Efficacy of Ophthalmic NSAIDs in Common Indications: A Literature Review to Support Cost-effective Prescribing. Ann Pharmacother. 2015;49(6):727–734. DOI: 10.1177/1060028015574593.
20. Donnenfeld E.D., 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. DOI: 10.1097/01.iio.0000212134.83513.11.
21. Yanni J.M., Graff G., Hellberg M.R. Topically administrable compositions containing 3- benzoylphenylaceteic acid derivatives for treatment of ophthalmic inflammatory disorders. Alcon Laboratories, Inc., assignee. US Patent 5,475,034. December 12, 1995.
22. Walters T., Raizman M., Ernest P. et al. In vivo pharmacokinetics and in vitro pharmacodynamics of nepafenac, amfenac, ketorolac, and bromfenac. J Cataract Refract Surg. 2007;33(9):1539–1545. DOI: 10.1016/j.jcrs.2007.05.015.
23. Ahuja M., Dhake A.S., Sharma S.K. et al. Topical ocular delivery of NSAIDs. AAPS J. 2008;10(2):229–241. DOI: 10.1208/s12248-008-9024-9.
24. Ogawa T., Miyake K., McNamara T.R. et al. Pharmacokinetic profile of topically applied bromfenac sodium ophthalmic sodium ophthalmic solution 0.1% in subjects undergoing cataract surgery. Proceedings of the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, Ft. Lauderdale, FL, April 30–May 4, 2006. A687.
25. Baklayan G.A., Muñoz M. The ocular distribution of 14C-labeled bromfenac ophthalmic solution 0.07% in a rabbit model. Clin Ophthalmol. 2014;8:1717–1724. DOI: 10.2147/OPTH.S66638.
26. Kida T., Kozai S., Takahashi H. et al. Pharmacokinetics and Efficacy of Topically Applied Nonsteroidal Anti-Inflammatory Drugs in Retinochoroidal Tissues in Rabbits. PLoS ONE. 2014;9(5):e96481. DOI: 10.1371/journal.pone.0096481.
27. Baklayan G.A., Patterson H.M., Song C.K. et al. 24-hour evaluation of the ocular dis- tribution of (14) C-labeled bromfenac following topical instillation into the eyes of New Zealand white rabbits, J. Ocul. Pharmacol. Ther. 2008;24:392–398. DOI: 10.1089/jop.2007.0082.
28. Naoko K., Hidemi S., Masahiko F. Post-Marketing Surveillance of Bromfenac Sodium (BRONUCK) Ophthalmic Solution-Use-Results Surveillance. Atarashii Ganka. 2005;22:1299-1308.
29. Томилова Е.В., Немсицверидзе М.Н., Панова И.Е. Влияние медикаментозной терапии на эпителизацию роговичного разреза после факоэмульсификации. Вестник офтальмологии. 2017;3:6–11. [Tomilova E.V., Nemsitsveridze M.N., Panova I.E. Effect of medicinal treatment on epithelial wound healing after phacoemulsification. Vestnikoftalmologii. 2017;3:6–11 (in Russ.)]. DOI: 10.17116/oftalma20171333.
30. Гобеджишвили М.В., Астахов С.Ю., Куглеев А.А. Макулярный отек при псевдофакии. Офтальмологические ведомости. 2011;4(4):57–59. [Gobedzhishvili M.V., Astakhov S.Yu., Kugleev A.A. Macular edema in pseudophakia. Oftal’mologicheskie vedomosti. 2011;4(4):57–59 (in Russ.)].
31. Behndig A., Lundberg B.J. Transient corneal edema after phacoemulsification: comparison of 3 viscoelastic regimens. J. Cataract Refract. Surg. 2002;28(9):1551–1556. DOI: 10.1016/s0886-3350(01)01219-6.
32. Behndig A., Lundberg B.J. Mydriatic response to different concentrations of intracameral phenylephrine in humans. J. Cataract Refract. Surg. 2010;36(10):1682–1686. DOI: 10.1016/j.jcrs.2010.04.036.
33. Lebraud P., Adenis J.P., Franco J.L. et al. Cystoid macular edema of pseudophakic patients (retrospective study with 300 pseudophakic patients). Bull. Soc. Ophthalmol. Fr. 1987;87(12):1437–1439.
34. Mentes J., Erakgun T., Afrashi F., Kerci G. Incidence of cystoids macular edema after uncomplicated phacoemulsification. Ophthalmologica. 2003;217(6):408–412. DOI: 10.1159/000073070.
35. Henderson B.A., Pineda R. Essentials of cataract surgery. Slack. Inc. 2007:187–200.
36. Gross J. Xibrom (bromfenac) reduces macular edema associated with vien occlu- sion, macular epiretinal membrane, diabetic retinopathy and age related macular degeneration. Poster F-3, 40th Meeting of thr Retina Society, Boston; 2007.
37. Silverstein S.M., Jackson M.A., Goldberg D.F., Muñoz M. The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zeroto-trace anterior chamber cell severity following cataract surgery. Clin. Ophthalmol. 2014;8:965–972. DOI: 10.2147/OPTH.S60292.
38. Song S.H. Effect of 0.1% Bromfenac for Preventing Macular Edema after Cataract Surgery in Patients with Diabetes. Korean Journal of Ophthalmology. 2020;34(1):46–55. DOI: 10.3341/kjo.2019.0044.
39. Rho D.S., Soll S.M., Markovitz B.J. Bromfenac 0,09% versus diclofenac sodium 0,1% versus ketorolac tromethamine 0,5% in the treatment of acute pseudophakic cys- toid macular edema. Invest.Ophthalmol. Vis. Sci. 2006;47.
40. Donnenfeld E.D., Holland E.J., Stewart R. et al. Topical Xibrom 0,1% an investigational NSAID, significantlyand rapidly decreased post-cataract surgery inflammation and reduced ocular pain. Invest. Ophthalmol. Vis. Sci. 2005;46(E-abstract 791).
41. Cable M. Clinical outcomes of BROMDAY Versus Nepafenac, Presented at: Annual Meeting of American Siciety of Retinal Specialists, Boston, 2011.
42. Ohara K., Ohkubo A., Miyamoto T. Prevention of miosis during cataract surgery by topical bromfenac sodium. Rinsho Ganka (Jpn J Clin Ophthalmol). 2004;58:1325–1328.
43. Ocular NSAIDs: a new option. Insert. to Cataract and Refractive Surgery Today. 2006:8.
44. Usui M., Masuda K. Effect of bromfenac sodium (AHR-10282B) eye drops on anterior uveitis. Ganka Rinsho Iho (J Rev Clin Ophthalmol). 1997;91:39–44.
45. Ocular Surgery News: Ista announces positive results from phase 2 trial of low- dose bromfenac in dry eye disease. 2009.
46. Schechter B.A. Ketorolac during the induction phase of cyclosporin-A therapy J. Ocular. Pharmacol. Ther. 2006;22(2):150–154. DOI: 10.1089/jop.2006.22.150.
47. Miyake-Kashima M., Takano Y., Tanaka M. et al. Comparision of 0.1% bromfenac sodium and 0.1% pemirolast potassium for the treatment of allergic conjunctivitis. Jpn. J. Ophthalmol. 2004;48:587–590. DOI: 10.1007/s10384-004-0127-2.
48. Fujishima H., Fukagawa K., Takano Y. et al. Comparison of efficacy of bromfenac sodium 0.1% ophthalmic solution and fluorometholone 0.02% ophthalmic suspension for the treatment of allergic conjunctivitis, J. Ocul. Pharmacol. Ther. 2009;25(3):265–270. DOI: 10.1089/jop.2008.0121.
49. Grant C.A. Combination therapy: lucentis (ranibizumab injection) and xibrom (bromfenac ophthalmic solution) 0.09% in the treatment of choroidal neovascular membrane secondary to age-related macular degeneration. Invest. Ophthalmol. Vis. Sci. 2008;49(E-Abstract 563).
50. Gomi F., Sawa M., Tsujikawa M., Nishida K. Topical bromfenac as an adjunctive treatment with intravitreal ranibizumab for exudative age-related macular degeneration. Retina. 2012;32(9):1804–1810. DOI: 10.1097/IAE.0b013e31825be87f.
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