Combigan (Brimonidine Tartrate / Timolol Maleate Ophthalmic) - Summary

COMBIGAN SUMMARY

COMBIGAN™ (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist with a non-selective beta-adrenergic receptor inhibitor (topical intraocular pressure lowering agent).

COMBIGAN™ (brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is an alpha adrenergic receptor agonist with a beta adrenergic receptor inhibitor indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP; the IOP-lowering of COMBIGAN™ dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.

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NEWS HIGHLIGHTS

Published Studies Related to Combigan (Brimonidine / Timolol Ophthalmic)

[Effect on ocular blood flow of Combigan(R) versus placebo in patients with ocular hypertension]. [2011.02]
PURPOSE: This study was undertaken to compare the ocular haemodynamic effects of Combigan((R)) versus placebo in patients with ocular hypertension (OHT)... CONCLUSIONS: Patients treated for 3 months with Combigan((R)) showed a significant decrease of CRA resistive index that could be explained by the decrease in IOP. Copyright (c) 2011. Published by Elsevier Espana.

Comparison of ocular hypotensive actions of fixed combinations of brimonidine/timolol and dorzolamide/timolol. [2010.07]
OBJECTIVE: To compare brimonidine/timolol fixed combination (BrTFC; Combigan *) with dorzolamide/timolol fixed combination (DTFC; Cosopt dagger) in terms of ability to lower intraocular pressure (IOP) in primary open-angle glaucoma (POAG)... CONCLUSION: Reductions from baseline in mean diurnal IOP and morning IOP were greater with BrTFC than with DTFC.

Effect of brimonidine/timolol fixed combination on preventing the short-term intraocular pressure increase after intravitreal injection of ranibizumab. [2010.04]
BACKGROUND: The aim of this study was to evaluate the safety and efficacy of brimonidine 0.2 % and timolol 0.5 % instillation as a fixed combination (Combigan, Allergan Inc.) to prevent acute intraocular pressure (IOP) increase occurring after intravitreal injection of ranibizumab (Lucentis, Novartis Pharma AG)... CONCLUSIONS: The use of Combigan drops twice a day the day before and the day of injection in eyes scheduled for intravitreal injection of Lucentis is a safe and effective prophylaxis to reduce the acute IOP spikes of the post-injection period. Copyright Georg Thieme Verlag KG Stuttgart . New York.

An eight-week, multicentric, randomized, interventional, open-label, phase 4, parallel comparison of the efficacy and tolerability of the fixed combination of timolol maleate 0.5%/brimonidine tartrate 0.2% versus fixed combination of timolol maleate 0.5%/dorzolamide 2% in patients with elevated intraocular pressure. [2008.12]
PURPOSE: To compare the efficacy and tolerability of the fixed combination of timolol maleate 0.5%/brimonidine tartrate 0.2% versus fixed combination of timolol maleate 0.5%/dorzolamide 2% in patients with elevated intraocular pressure (IOP) over 8 weeks... CONCLUSIONS: Both fixed combinations were capable of significantly reducing the mean diurnal IOP, mean diurnal peak, and mean WDT peak after 8 weeks of treatment. Also, both fixed combinations are well tolerated with few side effects.

Twenty-four-hour efficacy of the brimonidine/timolol fixed combination versus therapy with the unfixed components. [2008.11]
PURPOSE: To evaluate the 24-h intraocular pressure (IOP) control of brimonidine/timolol fixed combination (BTFC) versusthe unfixed combination of its individual components, each dosed twice daily, in patients with primary open-angle glaucoma or ocular hypertension... CONCLUSION: This study suggests that both BTFC and the unfixed components of brimonidine and timolol provide a significant 24-h IOP reduction from untreated baseline, and statistically equal control when compared directly, at each time point and for the 24-h pressure curve.

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Clinical Trials Related to Combigan (Brimonidine / Timolol Ophthalmic)

A Investigator Masked Parallel Comparison of Tolerability of Combigan and Cosopt [Recruiting]

Effect of Xalacom® (Latanoprost/Timolol) and Combigan® (Brimonidine/Timolol) Fixed Combination on Intraocular Pressure and Ocular Blood Flow in Patients With Primary Open Angle Glaucoma or Ocular Hypertension [Recruiting]
Glaucoma is one of the most common causes of blindness in the industrialized nations. For a long time glaucoma has been defined as a disease in which high intraocular pressure (IOP) leads to irreversible optic disc damage and subsequent visual field loss. However, recent investigations show that IOP is not the only factor that is involved in the glaucomatous process leading to retinal ganglion cell death. The role of vascular factors in the pathogenesis of glaucoma has recently received much attention based on animal experiments and epidemiological studies. The main focus of glaucoma is still directed towards a decrease in IOP. There is, however, also considerable interest whether antiglaucoma drugs influence ocular perfusion. Although measurement of ocular blood flow is still difficult, a number of innovative techniques have been realized which cover different aspects of ocular perfusion. In the present study Xalacom® (latanoprost/timolol) and the fixed combination of Combigan® (brimonidine/timolol) will be compared with respect to their IOP lowering efficacy as well as their ocular hemodynamic effects.

Efficacy and Safety Study of Combigan and 0.5% Timoptic in Normal Tension Glaucoma [Recruiting]

Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects [Recruiting]
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.

Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Latin America [Recruiting]
The objective of this study is to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.

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Reports of Suspected Combigan (Brimonidine / Timolol Ophthalmic) Side Effects

Ocular Hyperaemia (27),  Eye Irritation (23),  Eye Pruritus (17),  Eye Pain (15),  Dizziness (11),  Headache (9),  Hypersensitivity (8),  Erythema of Eyelid (8),  Vision Blurred (8),  Dyspnoea (7), more >>