Twice-Daily Brinzolamide/Brimonidine Fixed Combination versus Brinzolamide or Brimonidine in Open-Angle Glaucoma or Ocular Hypertension

Aung, Tin; Laganovska, Guna; Paredes, Tania Josefina Hernandez; Branch, James D.; Tsorbatzoglou, Alexis; Goldberg, Ivan

doi:10.1016/j.ophtha.2014.06.022

Cited by 43 publications

(34 citation statements)

References 16 publications

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“…8 In randomized, double-masked trials, treatment with BBFC 2 times daily (BID; approved dosing in most countries) or 3 times daily (approved dosing in the United States) significantly reduced IOP by ~20–35% from baseline, and BBFC was more effective than either of its components. 9, 10, 11, 12, 13 …”

Section: Introductionmentioning

confidence: 99%

Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial

Fechtner

Myers

Hubatsch

et al. 2016

Eye

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PurposeTo determine whether intraocular pressure (IOP) lowering with fixed-combination brinzolamide/brimonidine (BBFC) adjunctive to a prostaglandin analog (PGA) was superior to that of vehicle+PGA in patients with open-angle glaucoma or ocular hypertension who were inadequately controlled with PGA monotherapyMethodsThis 6-week, multicenter, randomized, double-masked, parallel-group trial was conducted at 30 clinical sites in the United States between October 2013 and May 2014. Eligible patients were adults with open-angle glaucoma or ocular hypertension and with mean IOP ≥21 and <32 mm Hg, whereas receiving an open-label PGA (latanoprost, bimatoprost, or travoprost). Patients instilled a PGA once-daily in a run-in phase before randomization to masked BBFC or vehicle adjunctive treatment. Masked treatments were instilled 3 times daily for 6 weeks, and patients continued once-daily use of their PGA. The primary efficacy end point was the between-group difference in mean diurnal IOP (average of 0800, 1000, 1500, and 1700 hours time points) at week 6.ResultsAt week 6, mean diurnal IOP with BBFC+PGA was lower than with vehicle+PGA (17.1±0.4 mm Hg vs 20.5±0.4 mm Hg; between-group difference, −3.4±0.5 mm Hg; P<0.0001; 95% confidence interval, −4.5 to −2.4 mm Hg). BBFC+PGA reduced mean diurnal IOP by 5.7 mm Hg (25%) from the baseline IOP achieved with PGA monotherapy.ConclusionsTherapy with BBFC produced an additive IOP-lowering effect compared with a PGA alone or in conjunction with vehicle. BBFC may provide an effective treatment option for patients receiving PGA monotherapy who require additional IOP reduction.

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Section: Introductionmentioning

confidence: 99%

Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial

Fechtner

Myers

Hubatsch

et al. 2016

Eye

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“…After 6 months' treatment, BBFC, administered twice daily, was significantly more effective in terms of IOP reduction than either of its components prescribed individually. 22 In this study, for the primary end-point -mean change in diurnal IOP from baseline to month 3 -BBFC lowered mean diurnal IOP to a significantly greater extent than either of its individual components. At 6 months, the least squares mean changes in IOP from baseline were: BBFC, -7.8 mmHg; brinzolamide, -6.7 mmHg (p<0.0001 versus BBFC); brimonidine, -6.4 mmHg (p<0.0001 versus BBFC) (see Figure 1).…”

Section: Overview Of European Clinical Studies Of Brinzolamide 1%/brimentioning

confidence: 62%

Early Clinical Experiences with Brinzolamide/Brimonidine Fixed Combination in Open-angle Glaucoma and Ocular Hypertension

Gandolfi¹

2017

European Ophthalmic Review

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T he fixed combination of brinzolamide 10 mg/ml and brimonidine 0.2% 2 mg/ml (BBFC; Simbrinza ® ) is an important addition to the glaucoma treatment choices currently available. Glaucoma is an increasingly prevalent disease worldwide, particularly in the elderly, and causes a serious burden of blindness. Fixed combinations of eye drops simplify treatment regimens, improving compliance, which helps maintain intraocular pressure (IOP) reductions. Registration of BBFC in Europe was supported by two phase III trials. In the first (n=560), after 6 months of treatment, BBFC twice daily lowered IOP by -1.4 mmHg more than brinzolamide alone, and by -1.5 mmHg more than brimonidine alone (least squares mean differences, p<0.0001 for both versus BBFC). BBFC was well tolerated with a safety profile similar to its two components. In the other of these trials (n=411), BBFC was non-inferior to brinzolamide and brimonidine given as separate doses concomitantly (B + B). The adverse events were similar in each group, with a slightly higher incidence in the B + B group. In the US, registration of BBFC in glaucoma was supported by three phase III and one phase IV trials, which also showed significantly greater IOP reduction with BBFC compared with its components alone and showed similar safety profiles. Additional phase IV studies are in progress to evaluate the combined use of BBFC with travoprost and timolol. BBFC has been clinically available in the US and Europe for only a short time, but its clinical trial efficacy suggests it will have a positive impact on real-world glaucoma and may have utility for earlier administration than its current third-or fourth-line use.

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“…In two Phase III randomized controlled trials in individuals with glaucoma, brinzolamide/brimonidine eye drops were statistically significantly superior to either constituent drug administered alone as monotherapy in reducing IOP at three months [124, 125]. The combination eye drops were noninferior to brinzolamide plus brimonidine administered concomitantly [126, 127]. …”

Section: Contemporary Pharmacological Management Of Glaucomamentioning

confidence: 99%

Medical Management of Glaucoma in the 21st Century from a Canadian Perspective

Harasymowycz

Birt

Gooi

et al. 2016

Journal of Ophthalmology

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Glaucoma is a medical term describing a group of progressive optic neuropathies characterized by degeneration of retinal ganglion cells and retinal nerve fibre layer and resulting in changes in the optic nerve head. Glaucoma is a leading cause of irreversible vision loss worldwide. With the aging population it is expected that the prevalence of glaucoma will continue to increase. Despite recent advances in imaging and visual field testing techniques that allow establishment of earlier diagnosis and treatment initiation, significant numbers of glaucoma patients are undiagnosed and present late in the course of their disease. This can lead to irreversible vision loss, reduced quality of life, and a higher socioeconomic burden. Selection of therapeutic approaches for glaucoma should be based on careful ocular examination, patient medical history, presence of comorbidities, and awareness of concomitant systemic therapies. Therapy should also be individualized to patients' needs and preferences. Recent developments in this therapeutic field require revisiting treatment algorithms and integration of traditional and novel approaches in order to ensure optimal visual outcomes. This article provides an overview of recent developments and practice trends in the medical management of glaucoma in Canada. A discussion of the surgical management is beyond the scope of this paper.

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Twice-Daily Brinzolamide/Brimonidine Fixed Combination versus Brinzolamide or Brimonidine in Open-Angle Glaucoma or Ocular Hypertension

Cited by 43 publications

References 16 publications

Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial

Ocular hypotensive effect of fixed-combination brinzolamide/brimonidine adjunctive to a prostaglandin analog: a randomized clinical trial

Early Clinical Experiences with Brinzolamide/Brimonidine Fixed Combination in Open-angle Glaucoma and Ocular Hypertension

Medical Management of Glaucoma in the 21st Century from a Canadian Perspective

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