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Drug Evaluation

Efficacy and safety of bromfenac 0.075% formulated in DuraSite for pain and inflammation in cataract surgery

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Pages 1703-1709 | Received 25 Sep 2018, Accepted 16 Jul 2019, Published online: 25 Jul 2019

References

  • Lindstrom R Thoughts on cataract surgery: 2015: review of opthalmology; 2015 cited 2018 Sep 20. Available from: https://www.reviewofophthalmology.com/article/thoughts-on–cataract-surgery-2015
  • Benitah NR, Arroyo JG. Pseudophakic cystoid macular edema. Int Ophthalmol Clin. 2010 Winter;50(1):139–153.
  • Gass JD, Norton EW. Cystoid macular edema and papilledema following cataract extraction. A fluorescein fundoscopic and angiographic study. Arch Ophthalmol. 1966 Nov;76(5):646–661.
  • Gass JD, Norton EW. Fluorescein studies of patients with macular edema and papilledema following cataract extraction. Trans Am Ophthalmol Soc. 1966;64:232–249.
  • Irvine SR. A newly defined vitreous syndrome following cataract surgery. Am J Ophthalmol. 1953 May;36(5):599–619.
  • NDA 206911 1.14.2.3 Final Labeling Text. FDA.gov: FDA; 2016. p. 2–3.
  • 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 Jun;22(6):1133–1140.
  • Dubois RN, Abramson SB, Crofford L, et al. Cyclooxygenase in biology and disease. Faseb J. 1998 Sep;12(12):1063–1073.
  • Masferrer JL, Kulkarni PS. Cyclooxygenase-2 inhibitors: a new approach to the therapy of ocular inflammation. Surv Ophthalmol. 1997 Feb;41(Suppl 2):S35–40.
  • Robinson DR. Prostaglandins and the mechanism of action of anti-inflammatory drugs. Am J Med. 1983 Oct 31;75:(4b):26–31.
  • Abel R Jr., Abel AD. Perioperative antibiotic, steroidal, and nonsteroidal anti-inflammatory agents in cataract intraocular lens surgery. Curr Opin Ophthalmol. 1996 Feb;7(1):39–42.
  • Ahuja M, Dhake AS, Sharma SK, et al. Topical ocular delivery of NSAIDs. Aaps J. 2008 Jun;10(2):229–241.
  • Colin J. The role of NSAIDs in the management of postoperative ophthalmic inflammation. Drugs. 2007;67(9):1291–1308.
  • Schalnus R. Topical nonsteroidal anti-inflammatory therapy in ophthalmology. Ophthalmol J Int D’ophtalmologie Int J Ophthalmol Zeitschrift Fur Augenheilkunde. 2003 Mar–Apr;217(2):89–98.
  • Bowling B. Kanski’s clinical ophthalmology: a systematic approach. 8th ed. London, England: Elsevier; 2016. p. 254.
  • Chad Lesczynski P. In: Scott Wentz M, editor; 2018.
  • Friedlaender MH, Protzko E. Clinical development of 1% azithromycin in duraSite, a topical azalide anti-infective for ocular surface therapy. Clin Ophthalmol. 2007 Mar;1(1):3–10.
  • BromSite(TM) (bromfenac ophthalmic solution) 0.075% bromsite website cited 2018 May 28. Available from: https://www.bromsite.com
  • Jabs DA, Nussenblatt RB, Rosenbaum JT. Standardization of uveitis nomenclature for reporting clinical data. Results of the first international workshop. Am J Ophthalmol. 2005 Sep;140(3):509–516.
  • Malik A, Sadafale A, Gupta YK, et al. A comparative study of various topical nonsteroidal anti-inflammatory drugs to steroid drops for control of post cataract surgery inflammation. Oman J Ophthalmol. 2016 Sep-Dec;9(3):150–156.
  • Ricciotti E, FitzGerald GA. Prostaglandins and inflammation. Arterioscler Thromb Vasc Biol. 2011 May;31(5):986–1000.
  • Duan P, Liu Y, Li J. The comparative efficacy and safety of topical non-steroidal anti-inflammatory drugs for the treatment of anterior chamber inflammation after cataract surgery: a systematic review and network meta-analysis. Graefes Arch Clin Exp Ophthalmol. 2017 Apr;255(4):639–649.
  • Si EC, Bowman LM, Hosseini K. Pharmacokinetic comparisons of bromfenac in DuraSite and Xibrom. J Ocular Pharmacol Ther. 2011 Feb;27(1):61–66.
  • Sheppard JD, Cockrum PC, Justice A, et al. In vivo pharmacokinetics of bromfenac ophthalmic solution 0.075%, bromfenac ophthalmic solution 0.07%, and nepafenac/amfenac ophthalmic suspension 0.3% in rabbits. Ophthalmol Ther. 2018 May 14;7:157–165.
  • Trattler W, Hosseini K. Twice-daily vs. once-daily dosing with 0.075% bromfenac in DuraSite: outcomes from a 14-day phase 2 study. Ophthalmol Ther. 2017 Dec;6(2):277–284.
  • Hosseini K, Walters T, DaVanzo R, et al. A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects. Clin Ophthalmol. 2016;10:2311–2317.
  • Almeida DR, 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 Jan;34(1):64–69.
  • 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 Oct;146(4):554–560.
  • 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 Jan;34(1):57–63.
  • Wielders LHP, Schouten J, Winkens B, et al. European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1. J Cataract Refract Surg. 2018 Apr;44(4):429–439.
  • Heier JS, Topping TM, Baumann W, et al. Ketorolac versus prednisolone versus combination therapy in the treatment of acute pseudophakic cystoid macular edema. Ophthalmology. 2000 Nov;107(11):2034–2038. discussion 2039.
  • Kim CY, Park KH, Ahn J, et al. Treatment patterns and medication adherence of patients with glaucoma in South Korea. Br J Ophthalmol. 2017;101(6):801–807.
  • Paes AH, Bakker A, Soe-Agnie CJ. Impact of dosage frequency on patient compliance. Diabetes Care. 1997 Oct;20(10):1512–1517.
  • Bowman LM, Si E, Pang J, et al. Development of a topical polymeric mucoadhesive ocular delivery system for azithromycin. J Ocular Pharmacol Therapeut. 2009 Apr;25(2):133–139.
  • Georgakopoulos C, Tsapardoni F, Makri O. Effect of bromfenac on pain related to intravitreal injections: a randomized crossover study. Retina. 2017;37(2):388–395.
  • Cleaveland NA, De Mann DW, Carlson NE, et al. Efficacy and perioperative timing of bromfenac in the management of ocular discomfort after femtosecond laser–assisted laser in situ keratomileusis. J Cataract Refract Surg. 2017;43(2):183–188.
  • NSAID UPDATE. American society of cataract and refractive surgery; 1999.
  • Hargrave SL, Jung JC, Fini ME, et al. Possible role of the vitamin E solubilizer in topical diclofenac on matrix metalloproteinase expression in corneal melting: an analysis of postoperative keratolysis. Ophthalmology. 2002 Feb;109(2):343–350.
  • McIntyre BS, Briski KP, Gapor A, et al. Antiproliferative and apoptotic effects of tocopherols and tocotrienols on preneoplastic and neoplastic mouse mammary epithelial cells. Proc Soc Exp Biol Med. 2000 Sep;224(4):292–301.
  • Price FW. New pieces for the puzzle: nonsteroidal anti-inflammatory drugs and corneal ulcers. J Cataract Refract Surg. 2000 Sep;26(9):1263–1265.
  • Simmons DL, Botting RM, Robertson PM, et al. Induction of an acetaminophen-sensitive cyclooxygenase with reduced sensitivity to nonsteroid antiinflammatory drugs. Proc Natl Acad Sci U S A. 1999 Mar 16;96(6):3275–3280.
  • Donnenfeld E, 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.
  • Asai T, Nakagami T, Mochizuki M, et al. Three cases of corneal melting after instillation of a new nonsteroidal anti-inflammatory drug. Cornea. 2006 Feb;25(2):224–227.
  • Maguire J, CJ R, IJ U. Topical NSAIDs: best Practices for Safe Use. In: Burling-Phillips L, editor. American Academy of Ophthalmology; 2013. [cited 2019 Jan]. Available from: https://www.aao.org/eyenet/article/topical-nsaids-best-practices-safe-use?july-2013
  • Walters TR. An ex vivo human aqueous humor-concentration comparison of two commercial bromfenac formulations. Clin Ophthalmol. 2018;12:943–947.
  • Panara MR, Renda G, Sciulli MG, et al. Dose-dependent inhibition of platelet cyclooxygenase-1 and monocyte cyclooxygenase-2 by meloxicam in healthy subjects. J Pharmacol Exp Ther. 1999 Jul;290(1):276–280.
  • Bromfenac: drug Information - UpToDate. US: Pricing. cited 2018 May 28. Available from: https://www.uptodate.com/contents/bromfenac-drug-information?search=bromfenac&source=search_result&selectedTitle=1~5&usage_type=default&display_rank=1#F518366
  • Belair ML, Kim SJ, Thorne JE, et al. Incidence of cystoid macular edema after cataract surgery in patients with and without uveitis using optical coherence tomography. Am J Ophthalmol. 2009 Jul;148(1):128–35.e2.
  • BA H, JY K, CS A, et al. Clinical pseudophakic cystoid macular edema. Risk factors for development and duration after treatment. J Cataract Refract Surg. 2007 Sep;33(9):1550–1558.
  • Opitz DL, Harthan JS. Review of azithromycin ophthalmic 1% solution (AzaSite(®)) for the treatment of ocular infections. Ophthalmol Eye Dis. 2012;4:1–14.

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