811
Views
25
CrossRef citations to date
0
Altmetric
Drug Safety Evaluation

Brimonidine and brinzolamide for treating glaucoma and ocular hypertension; a safety evaluation

&
Pages 1071-1078 | Received 04 Apr 2017, Accepted 19 Jun 2017, Published online: 06 Jul 2017

References

  • Cantor LB. Brimonidine in the treatment of glaucoma and ocular hypertension. Ther Clin Risk Manag. 2006;2:337–346.
  • Cantor LB, WuDunn D, Catoira-Boyle Y, et al. Absorption of brimonidine 0.1% and 0.15% ophthalmic solutions in the aqueous humor of cataract patients. J Glaucoma. 2008;17:529–534.
  • Cantor LB, Safyan E, Liu CC, et al. Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension: a 12-month randomized trial. Curr Med Res Opin. 2008;24:2035–2043.
  • Arthur S, Cantor LB. Update on the role of alpha-agonists in glaucoma management. Exp Eye Res. 2011;93(3):271–283.
  • Cantor LB. The evolving pharmacotherapeutic profile of brimonidine, an alpha 2-adrenergic agonist, after four years of continuous use. Expert Opin Pharmacother. 2000;1:815–834.
  • Schuman JS, Horwitz B, Choplin NT, et al. A 1-year study of brimonidine twice daily in glaucoma and ocular hypertension. A controlled, randomized, multicenter clinical trial. Arch Ophthalmol. 1997;115:847–852.
  • Katz LJ. Brimonidine Study Group. Brimonidine tartrate 0.2% twice daily vs timolol 0.5% twice daily: 1-year results in glaucoma patients. Am J Ophthalmol. 1999;127:20–26.
  • Goldberg I, Crowston JG, Jasek MC, et al.; ADAPT Study Investigator Group. Intraocular pressure-lowering efficacy of brinzolamide when added to travoprost/timolol fixed combination as adjunctive therapy. J Glaucoma. 2012;21:55–59.
  • Michaud JE, Friren B. Comparison of topical brinzolamide 1% and dorzolamide 2% eye drops given twice daily in addition to timolol 0.5% in patients with primary open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2001;132:235–243.
  • March WF, Ochsner KI. The long-term safety and efficacy of brinzolamide 1.0% (Azopt) in patients with primary open-angle glaucoma or ocular hypertension. Am J Ophthalmol. 2000;129:136–143.
  • Silver LH. Clinical efficacy and safety of brinzolamide (Azopt), a new topical carbonic anhydrase inhibitor for primary open-angle glaucoma and ocular hypertension. Am J Ophthalmol. 1998;126:400–408.
  • Stewart WC, Kolker AE, Sharpe ED, et al. Long-term progression at individual mean intraocular pressure levels in primary open-angle and exfoliative glaucoma. Eur J Ophthalmol. 2008;18:765–770.
  • Gordon MO, Kass MA. The Ocular Hypertension Treatment Study: design and baseline description of the participants. Arch Ophthalmol. 1999;117:573–583.
  • Anderson DR. Collaborative normal tension glaucoma study. Curr Opin Ophthalmol. 2003;14:86–90.
  • Leske MC, Heijl A, Hyman L, et al. Early manifest glaucoma trial: design and baseline data. Ophthalmology. 1999;106:2144–2153.
  • Ederer F, Gaasterland DE, Sullivan EK, et al. The advanced glaucoma intervention study (AGIS): 1. Study design and methods and baseline characteristics of study patients. Control Clin Trials. 1994;15:299–325.
  • Musch DC, Lichter PR, Guire KE, et al. The collaborative initial glaucoma treatment study: study design, methods, and baseline characteristics of enrolled patients. Ophthalmology. 1999;106:653–662.
  • Foster PJ, Buhrmann R, Quigley HA, et al. The definition and classification of glaucoma in prevalence surveys. Br J Ophthalmol. 2002;86(2):238–242.
  • Mantravadi AV, Vadhar N. Glaucoma. Prim Care Clin Office Pract. 2015;42:437–449.
  • Pascolini D, Mariotti SP. Global estimates of visual impairment: 2010. Br J Ophthalmol. 2012;96:614–618.
  • Kingman S. Glaucoma is second leading cause of blindness globally. Bull World Health Organ. 2004;82(11):887–888.
  • Peters D, Bengtsson B, Heijl A. Factors associated with lifetime risk of open-angle glaucoma blindness. Acta Ophthalmol. 2014;92:421–425.
  • Stewart WC, Stewart JA, Nelson LA, et al. Physician attitudes regarding prostaglandin treatment for glaucoma in the United States and Europe. Eur J Ophthalmol. 2008;18:199–204.
  • Stein JD, Ayyagari P, Sloan FA, et al. Rates of glaucoma medication utilization among persons with primary open-angle glaucoma 1992 to 2002. Ophthalmology. 2008;115:1315–1319.
  • Sambhara D, Aref AA. Glaucoma management: relative value and place in therapy of available drug treatments. Ther Adv Chronic Dis. 2014;5(1):30–43.
  • Webers CA, Beckers HJ, Nuijts RM, et al. Pharmacological management of primary open-angle glaucoma: second-line options and beyond. Drugs Aging. 2008;25:729–759.
  • Kass MA, Heuer DK, Higginbotham EJ, et al. The Ocular Hypertension Treatment Study: a randomized trial determines that topical ocular hypotensive medication delays or prevents the onset of primary open-angle glaucoma. Arch Ophthalmol. 2002;120(6):701–713.
  • Boger WP. 3rd. Short-term “escape” and long-term “drift”. The dissipation effects of the beta adrenergic blocking agents. Surv Ophthalmol. 1983;28(Suppl):235–242.
  • Sharma S, Trikha S, Perera S, et al. Clinical effectiveness of brinzolamide 1%-brimonidine 0.2% fixed combination for primary open-angle glaucoma and ocular hypertension. Clin Ophthalmol. 2015;9:2201–2207.
  • Nguyen QH. Combination of brinzolamide and brimonidine for glaucoma and ocular hypertension: critical appraisal and patient focus. Patient Prefer Adherence. 2014;8:853–864.
  • Burke J, Schwartz M. Preclinical evaluation of brimonidine. Surv Ophthalmol. 1996;41(suppl 1):S9–18.
  • Liu CJ, Cheng CY, Ko YC, et al. Diurnal intraocular pressure and blood pressure with two dosing regimens of brimonidine in normal tension glaucoma. J Chin Med Assoc. 2004;67:465–471.
  • Toris CB, Gleason ML, Camras CB, et al. Effects of brimonidine on aqueous humor dynamics in human eyes. Arch Ophthalmol. 1995;113:1514–1517.
  • Toris CB, Camras CB, Yablonski ME. Effects of brimonidine on aqueous humor dynamics in human eyes. Arch Ophthalmol. 1995;113:1514–1517.
  • Walters TR. Development and use of brimonidine in treating acute and chronic elevations of intraocular pressure: a review of safety, efficacy, dose response, and dosing studies. Surv Ophthalmol. 1996;41(Suppl 1):S19–26.
  • Yoles E, Wheeler LA, Schwartz M. Alpha2-adrenoreceptor agonists are neuroprotective in a rat model of optic nerve degeneration. Invest Ophthalmol Vis Sci. 1999;40:65–73.
  • WoldeMussie E, Ruiz G, Wijono M, et al. Neuroprotection of retinal ganglion cells by brimonidine in rats with laser-induced chronic ocular hypertension. Invest Ophthalmol Vis Sci. 2001;42:2849–2855.
  • Donello JE, Padillo EU, Webster ML, et al. Alpha2-Adrenoceptor agonists inhibit vitreal glutamate and aspartate accumulation and preserve retinal function after transient ischemia. J Pharmacol Exp Ther. 2001;296:216–223.
  • Weinreb RN, Levin LA. Is neuroprotection a viable therapy for glaucoma? Arch Ophthalmol. 1999;117:1540–1544.
  • Krupin T, Liebmann JM, Greenfield DS, et al. A randomized trial of brimonidine versus timolol in preserving visual function: results from the low-pressure glaucoma treatment study. Am J Ophthalmol. 2011;151:671–681.
  • Fan N, Wang P, Tang L, et al. Ocular blood flow and normal tension glaucoma. Biomed Res Int. 2015. Epub Oct 19.
  • Gramer G, Weber BH, Gramer E. Migraine and vasospasm in glaucoma: age-related evaluation of 2027 patients with glaucoma or ocular hypertension. Invest Ophthalmol Vis Sci. 2015;56(13):7999–8007.
  • Kaiser HJ, Schoetzau A, Stump D, et al. Blood flow velocities of the extraocular vessels in patients with high-tension and normal-tension primary open-angle glaucoma. Am J Ophthalmol. 1997;123(3):320–327.
  • David R. Brimonidine (Alphagan): a clinical profile four years after launch. Eur J Ophthalmol. 2001;11(Suppl 2):S72–7.
  • Tsumura T, Yoshikawa K, Kimura T, et al. The efficacy and safety of add-on 0.1% brimonidine tartrate preserved with sodium chlorite in on-treatment Japanese normal-tension glaucoma patients. Clin Ophthalmol. 2014;8:1681–1687.
  • Lee AJ, McCluskey P. Fixed combination of topical brimonidine 0.2% and timolol 0.5% for glaucoma and uncontrolled intraocular pressure. Clin Ophthalmol. 2008;2(3):545–555.
  • Galanopoulos A, Goldberg I. Clinical efficacy and neuroprotective effects of brimonidine in the management of glaucoma and ocular hypertension. Clin Ophthalmol. 2009;3:117–122.
  • Blondeau P, Rousseau JA. Allergic reactions to brimonidine in patients treated for glaucoma. Can J Ophthalmol. 2002;37:21–26.
  • Nguyen EV, Azar D, Papalkar D, et al. Brimonidine-induced anterior uveitis and conjunctivitis: clinical and histologic features. J Glaucoma. 2008;17:40–42.
  • Katz LJ. Twelve-month evaluation of brimonidine-purite versus brimonidine in patients with glaucoma or ocular hypertension. J Glaucoma. 2002;11:119–126.
  • Manufacturer’s information: brimonidine tartrate ophthalmic solution, 0.15% product monograph. Fort Worth (TX): Alcon Ophthalmics; 2013 Sep.
  • Berlin RJ, Lee UT, Samples JR, et al. Ophthalmic drops causing coma in an infant. J Pediatr. 2001;138:441–443.
  • Daubert GP. Is brimonidine ophthalmic a safe therapy for infants? J Clin Pharm Ther. 2006;31:289–292.
  • Al-Shahwan S, Al-Torbak AA, Turkmani S, et al. Side-effect profile of brimonidine tartrate in children. Ophthalmology. 2005;112(2):2143.
  • Yoshidaa M, Okadaa E, Mizuki N, et al. Age-specific prevalence of open-angle glaucoma and its relationship to refraction among more than 60,000 asymptomatic Japanese subjects. J Clin Epidemiol. 2001;54:1151–1158.
  • Salim S. Glaucoma in pregnancy. Curr Opin Ophthalmol. 2014;25:93–97.
  • Sethi HS, Naik M, Gupta VS. Management of glaucoma in pregnancy: risks or choices, a dilemma? Int J Ophthalmol. 2016;9(11):1684–1690.
  • Coleman AL, Mosaed S, Kamal D. Medical therapy in pregnancy. J Glaucoma. 2005;14:414–416.
  • Goldenberg MM. Pharmaceutical approval update. Pharm Ther. 2013;38(6):323–324.
  • Li T, Lindsley K, Rouse B, et al. Comparative effectiveness of first-line medications for primary open angle glaucoma – a systematic review and network meta-analysis. Ophthalmology. 2016;123(1):129–140.
  • Butler P, Mannschreck M, Lin S, et al. Clinical experience with the long-term use of 1% apraclonidine. Incidence of allergic reactions. Arch Ophthalmol. 1995;113:293–296.
  • Feibel RM. High incidence of topical allergic reactions to 1% apraclonidine. Arch Ophthalmol. 1995;113:1579–1580.
  • Wright TM, Freedman SF. Exposure to topical apraclonidine in children with glaucoma. J Glaucoma. 2009;18(5):395–398.
  • Inoue K, Shiokawa M, Sugahara M, et al. Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension. Clin Ophthalmol. 2012;6:111–116.
  • Johnstone MA. Hypertrichosis and increased pigmentation of eyelashes and adjacent hair in the region of the ipsilateral eyelids of patients treated with unilateral topical latanoprost. Am J Ophthalmol. 1997;124(4):544–547.
  • Johnstone MA, Albert DM. Prostaglandin-induced hair growth. Surv Ophthalmol. 2002;47(Suppl 10):S185–S202.
  • Sakata R, Shirato S, Miyata K, et al. Incidence of deepening of the upper eyelid sulcus in prostaglandin-associated periorbitopathy with a latanoprost ophthalmic solution. Eye. 2014;28:1446–1451.
  • Zhang WY, Po AL, Dua HS, et al. Meta-analysis of randomised controlled trials comparing latanoprost with timolol in the treatment of patients with open angle glaucoma or ocular hypertension. Br J Ophthalmol. 2001;85:983–990.
  • Schuman JS. Effects of systemic beta-blocker therapy on the efficacy and safety of topical brimonidine and timolol. Ophthalmology. 2000;107:1171–1177.
  • Supuran C. Drug interaction considerations in the therapeutic use of carbonic anhydrase inhibitors. Expert Opin Drug Metab Toxicol. 2016;12(4):423–431.
  • Supuran C. Carbonic anhydrases: novel therapeutic applications for inhibitors and activators. Nature Rev Drug Discov. 2008;7:168–181.
  • Sugrue MF. The preclinical pharmacology of dorzolamide hydrochloride, a topical carbonic anhydrase inhibitor. J Ocul Pharmacol Ther. 1996;12:363–376.
  • Lester M. Brinzolamide ophthalmic suspension: a review of its pharmacology and use in the treatment of open angle glaucoma and ocular hypertension. Clin Ophthalmol. 2008;2(3):517–523.
  • Dean T, May J, Chen HH, et al. Brinzolamide (AL-4862) suspension is a new topically active carbonic anhydrase inhibitor in the Dutch-belted rabbits and cynomolgus monkey. Invest Ophthalmol Vis Sci. 1997;38(suppl):S813.
  • Wang TH, Huang JY, Hung PT, et al. Ocular hypotensive effect and safety of brinzolamide ophthalmic solution in open angle glaucoma patients. J Formos Med Assoc. 2004;103:369–373.
  • Van der Valk R, Webers CAB, Schouten JSAG, et al. Intraocular pressure-lowering effects of all commonly used glaucoma drugs. Meta-Anal Randomized Clin Trials Ophthalmol. 2005;112:1177–1185.
  • Shin D. The Brinzolamide Adjunctive Therapy Study Group. Adjunctive therapy with brinzolamide 1% ophthalmic suspension (AZOPT) in patients with open-angle glaucoma or ocular hypertension maintained on timolol therapy. Surv Ophthalmol. 2000;44(4 suppl 2):163–168.
  • Inoue K, Shiokawa M, Ishida K, et al. Safety and efficacy of switching from dorzolamide 1.0%/timolol maleate 0.5% eye drops to brinzolamide 1.0%/timolol maleate 0.5% eye drops. Clin Ophthalmol. 2015;9:619–623.
  • Cheng J-W, Cheng S-W, Gao L-D, et al. Intraocular pressure-lowering effects of commonly used fixed-combination drugs with timolol: a systematic review and meta-analysis. PLoS One. 2012;7(9):e45079.
  • Lanzl I, Raber T. Efficacy and tolerability of the fixed combination of brinzolamide 1% and timolol 0.5% in daily practice. Clin Ophthalmol. 2011;5:291–298.
  • Manni G, Denis P, Chew P, et al. The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension. J Glaucoma. 2009;18(4):293–300.
  • Skalicky SE, Goldberg I, McCluskey P. Ocular surface disease and quality of life in patients with glaucoma. Am J Ophthalmol. 2012;153(1):1–9.e2.
  • DeSantis L. Preclinical overview of brinzolamide. Surv Ophthalmol. 2000;44(Suppl 2):S119–29.
  • Zhao JC, Chen T. Brinzolamide induced reversible corneal decompensation. Br J Ophthalmol. 2005;89:389–390.
  • Menon GJ, Vernon SA. Topical brinzolamide and metabolic acidosis. Br J Ophthalmol. 2006;90:247–248.
  • Strom BL, Schinnar R, Apter AJ, et al. Absence of cross-reactivity between sulfonamide antibiotics and sulfonamide nonantibiotics. N Engl J Med. 2003;349:1628–1635.
  • Guedes GB, Karan A, Mayer HR, et al. Evaluation of adverse events in self-reported sulfa-allergic patients using topical carbonic anhydrase inhibitors. J Ocul Pharmacol Ther. 2013;29(5):456–461.
  • Whitson JT, Roarty JD, Vijaya L, et al. Efficacy of brinzolamide and levobetaxolol in pediatric glaucomas: a randomized clinical trial. J Aapos. 2008;12:239–246.
  • Brauner SC, Chen TC, Hutchinson T, et al. The course of glaucoma during pregnancy: a retrospective case series. Arch Ophthalmol. 2006;124:1089–1094.
  • Morris S, Geh V, Nischal K. Topical dorzolamide and metabolic acidosis in a neonate. Br J Ophthalmol. 2003;87:1052–1053.
  • Manufacturer’s information: azopt product monograph. Fort Worth (TX): Alcon Ophthalmics; 1998 [revised 2015 Nov].
  • Johnson SM, Martinez M, Freedman S. Management of glaucoma in pregnancy and lactation. Surv Ophthalmol. 2001;45(5):449–454.
  • Adamsons IA, Polis A, Ostrov CS, et al.; Dorzolamide Safety Study Group. Two-year safety study of dorzolamide as monotherapy and with timolol and pilocarpine. J Glaucoma. 1998;7:395–401.
  • Hu C-Y, Lee B-J, Cheng H-F, et al. Acetazolamide-related life-threatening hypophosphatemia in a glaucoma patient. J Glaucoma. 2015;24:e31–e33.
  • Lo JS, Pang PM, Lo SC. Efficacy and tolerability of brinzolamide/brimonidine suspension and prostaglandin analogs in patients previously treated with dorzolamide/timolol solution and prostaglandin analogs. Clin Ophthalmol. 2016;10:583.
  • Gandolfi SA, Lim J, Sanseau AC, et al. Randomized trial of brinzolamide/brimonidine versus brinzolamide plus brimonidine for open-angle glaucoma or ocular hypertension. Adv Ther. 2014;31:1213–1227.
  • Greig SL, Deeks ED. Brinzolamide/brimonidine: a review of its use in patients with open-angle glaucoma or ocular hypertension. Drugs Aging. 2015;32(3):251–260.
  • Realini T, Nguyen QH, Katz G, et al. Fixed-combination brinzolamide 1%/brimonidine 0.2% vs monotherapy with brinzolamide or brimonidine in patients with open-angle glaucoma or ocular hypertension: results of a pooled analysis of two phase 3 studies. Eye. 2013;27(7):841–847.
  • Nguyen QH, McMenemy MG, Realini T, et al. Phase 3 randomized 3-month trial with an ongoing 3-month safety extension of fixed-combination brinzolamide 1%/brimondine 0.2%. J Ocul Pharmacol Ther. 2013;29(3):290–297.
  • Richter GM, Coleman AL. Minimally invasive glaucoma surgery: current status and future prospects. Clin Ophthalmol. 2016;10:189–206.
  • Lusthaus JA, Goldberg I. Emerging drugs to treat glaucoma: targeting prostaglandin F and E receptors. Expert Opin Emerg Drugs. 2016;21(1):117–128.
  • Reardon G, Kotak S, Schwartz GF. Objective assessment of compliance and persistence among patients treated for glaucoma and ocular hypertension: a systematic review. Patient Prefer Adherence. 2011;5:441–463.
  • Sen DF, Lindsley K. Neuroprotection for treatment of glaucoma in adults. Cochrane Database Syst Rev. 2013;2:CD006539.
  • Doozandeh A, Yazdani S. Neuroprotection in glaucoma. J Ophthalmic Vis Res. 2016;11(2):209–220.
  • Inoue K, Soeda S, Tomita G. Comparison of Latanoprost/Timolol with carbonic anhydrase inhibitor and Dorzolamide/Timolol with prostaglandin analog in the treatment of glaucoma. J Ophthalmol. 2014;2014:975429.
  • Sun J, Lei Y, Dai Z, et al. Sustained release of brimonidine from a new composite drug delivery system for treatment of glaucoma. ACS Appl Mater Interfaces. 2017;9(9):7990–7999.
  • Li H, Liu Y, Zhang Y, et al. Liposomes as a novel ocular delivery system for brinzolamide: in vitro and in vivo studies. AAPS PharmSciTech. 2016;17(3):710–717.
  • Li J, Liu H, Liu LL, et al. Design and evaluation of a brinzolamide drug-resin in situ thermosensitive gelling system for sustained ophthalmic drug delivery. Chem Pharm Bull (Tokyo). 2014;62(10):1000–1008.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.