Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆

Belfort, Rubens; Paula, Jayter Silva; Silva, Marcelo Jordão Lopes; Paolera, Maurício Della; Kim, Thomas; Chen, Michelle Y.; Goodkin, Margot L.

doi:10.1016/j.clinthera.2019.12.008

Cited by 14 publications

(20 citation statements)

References 38 publications

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“…Another phase III study conducted in Brazil demonstrated that the mean IOP reduction at 12 weeks is 10.45 mmHg in patients treated with TBiBr-FC and 8.28 mmHg in those treated with BrT-FC. A total of 28.9, 36.8, and 71.1% of patients treated with TBiBr-FC achieved levels of IOP ≤13, ≤14, and ≤16 mmHg compared to 15.7, 22.9, and 55.4% in patients treated with BrT-FC ( Belfort et al, 2020 ). TBiBr-FC maybe a new promising fixed-combination three agents for patients whose IOP cannot be inadequate by combination two agents, but more clinical trials are needed to verify the effectiveness and safety.…”

Section: Topical Fixed Combination Of Three Agentsmentioning

confidence: 95%

“…Two comparative clinical studies demonstrated that TBiBr-FC has clinically and statistically significantly superior IOP lowering effects than BrT-FC ( Hartleben et al, 2017 ; Belfort et al, 2020 ). A phase 3 study conducted in Mexico and Colombia revealed that the mean IOP changes from baseline are 10.03 and 9.18 mmHg, and percentage of IOP ≤13 mmHg is 33.7 and 14.8% for TBiBr-FC and BrT-FC respectively, after 12 weeks ( Hartleben et al, 2017 ).…”

Section: Topical Fixed Combination Of Three Agentsmentioning

confidence: 99%

“…The most common AEs are ocular side effects and none are serious in TBiBr-FC and BrT-FC-treated patients ( Hartleben et al, 2017 ; Belfort et al, 2020 ). The most common AEs include conjunctival hyperemia, eye irritation, allergic blepharitis, allergic conjunctivitis, and dry eye.…”

Section: Topical Fixed Combination Of Three Agentsmentioning

confidence: 99%

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Topical Medication Therapy for Glaucoma and Ocular Hypertension

Wang

Cao²,

Jiang³

et al. 2021

Front. Pharmacol.

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Glaucoma is one of the most common causes of blindness, thus seriously affecting people’s health and quality of life. The topical medical therapy is as the first line treatment in the management of glaucoma since it is inexpensive, convenient, effective, and safe. This review summarizes and compares extensive clinical trials on the topical medications for the treatment of glaucoma, including topical monotherapy agents, topical fixed-combination agents, topical non-fixed combination agents, and their composition, mechanism of action, efficacy, and adverse effects, which will provide reference for optimal choice of clinical medication. Fixed-combination therapeutics offer greater efficacy, reliable security, clinical compliance, and tolerance than non-fixed combination agents and monotherapy agents, which will become a prefer option for the treatment of glaucoma. Meanwhile, we also discuss new trends in the field of new fixed combinations of medications, which may better control IOP and treat glaucoma.

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Section: Topical Fixed Combination Of Three Agentsmentioning

confidence: 95%

Section: Topical Fixed Combination Of Three Agentsmentioning

confidence: 99%

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Topical Medication Therapy for Glaucoma and Ocular Hypertension

Wang

Cao²,

Jiang³

et al. 2021

Front. Pharmacol.

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“…Их комбинации обладают максимально выраженным аддитивным эффектом. Альфа-2-адреномиметики (например, бримонидин 0,2%) широко используются в лечении глаукомы как в фиксированных, так и в раздельных комбинациях [3,4]. Нейропротекторный эффект бримонидина изучался в экспериментальных и клинических исследованиях.…”

Section: Introductionunclassified

Brimonidine as an additional treatment for moderate glaucoma

Газизова¹,

Korelina²

2021

Russian Journal of Clinical Ophthalmology

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Aim: to assess the utility of brimonidine 0.2% as an additional IOP-lowering treatment for moderate glaucoma. Patients and Methods: 99 patients (121 eyes) aged 62–73 years with moderate glaucoma were enrolled. All patients were divided into four groups based on IOP-lowering medications. In group 1, prostaglandin analogues (latanoprost) and beta blockers (timolol) were prescribed. In group 2, carbonic anhydrase inhibitors (dorzolamide) and beta blockers (timolol) were prescribed. In group 3, brimonidine 0.2% was added to prostaglandin analogues and beta blockers. In group 4, brimonidine 0.2% was added to carbonic anhydrase inhibitors and beta blockers. All patients underwent IOP measurements and static automated perimetry (SAP) at baseline and after 6 and 12 months. Results: additional treatment (brimonidine) gradually reduced IOP levels in groups 3 and 4, while in groups 1 and 2 IOP levels were stable. In group 1, mean deviation (MD) increased from -10.7±4.5dB to -10.8±3.8 dB after 6 months but reduced to -10.5±3.4 dB after 12 months. In group 2, MD increased from -11.7±5.1 dB to -12.0±3.2 dB after 6 months and -12.5±2.9 dB after 12 months. In group 3, MD reduced from -13.5±4.1 dB to -12.9±3.6 dB after 6 months and -12.7±3.0 dB after 12 months. In group 4, MD reduced from -13.9±4.6 dB to -13.0±4.1 dB after 6 months and increased to -13.1±3.5 dB after 12 months. Pattern standard deviation (PSD) was stable in all four groups. Conclusion: brimonidine as an additional treatment for moderate and advanced glaucoma results in stable IOP reduction. Combined therapy which includes brimonidine preserves visual functions even in moderate-to-advanced glaucoma. The neuroprotective effect of brimonidine is illustrated by SAP. This medication is well tolerated. Keywords: glaucoma, IOP, visual field, perimetry, tonometry, neuroprotection. For citation: Gazizova I.R., Korelina V.E. Brimonidine as an additional treatment for moderate glaucoma. Russian Journal of Clinical Ophthalmology. 2021;21(2):69–71. DOI: 10.32364/2311-7729-2021-21-2-69-71.

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“…In an attempt to better optimize the ophthalmic therapies with TM and exploit the success of co-administering two or more drugs (having synergistic effect on glaucoma) in a single formulation [29][30][31][32], a co-loading drug delivery strategy has also been explored. Although some evidence exists in the literature, for example nanosheet [17] and micelle coloading TM with latanoprost [33], however, fewer works with liposomes have been found.…”

Section: Introductionmentioning

confidence: 99%

Synergistic Effect of Acetazolamide-(2-hydroxy)propyl β-Cyclodextrin in Timolol Liposomes for Decreasing and Prolonging Intraocular Pressure Levels

et al. 2021

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The purpose of this study was to design, for the first time, a co-loaded liposomal formulation (CLL) for treatment of glaucoma including timolol maleate (TM) in the lipid bilayer and acetazolamide (Acz)-(2-hydroxy)propyl β-cyclodextrin (HPβCD) complexes (AczHP) solubilized in the aqueous core of liposomes. Formulations with TM (TM-L) and AczHP (AczHP-L), separately, were also prepared and characterized. A preliminary study comprising the Acz/HPβCD complexes and their interaction with cholesterol (a component of the lipid bilayer) was realized. Then, a screening study on formulation factors affecting the quality of the product was carried out following the design of the experiment methodology. In addition, in vitro release and permeation studies and in vivo lowering intraocular pressure (IOP) studies were performed. The results of the inclusion complexation behavior, characterization, and binding ability of Acz with HPβCD showed that HPβCD could enhance the water solubility of Acz despite the weak binding ability of the complex. Ch disturbed the stability and solubility parameters of Acz due to the fact of its competence by CD; thus, Chems (steroid derivative) was selected for further liposome formulation studies. The optimization of the lipid bilayer composition (DDAB, 0.0173 mmol and no double loading) and the extrusion as methods to reduce vesicle size were crucial for improving the physico-chemical properties and encapsulation efficiency of both drugs. In vitro release and permeation studies demonstrated that the CLL formulation showed improvement in in vitro drug release and permeation compared to the liposomal formulations with a single drug (TM-L and AczHP-L) and the standard solutions (TM-S and AczHP-S). CLL showed high efficacy in reducing and prolonging IOP, suggesting that the synergistic effect of TM and Acz on aqueous humor retention and the presence of this cyclodextrin and liposomes as permeation enhancers are responsible for the success of this strategy of co-loading for glaucoma therapy.

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Fixed-combination Bimatoprost/Brimonidine/Timolol in Glaucoma: A Randomized, Masked, Controlled, Phase III Study Conducted in Brazil☆

Abstract: Purpose:Many patients with open-angle glaucoma eventually require >2 medications to lower their intraocular pressure (IOP). Fixed-combination ophthalmic solutions can be advantageous in patients

Cited by 14 publications

References 38 publications

Topical Medication Therapy for Glaucoma and Ocular Hypertension

Topical Medication Therapy for Glaucoma and Ocular Hypertension

Brimonidine as an additional treatment for moderate glaucoma

Synergistic Effect of Acetazolamide-(2-hydroxy)propyl β-Cyclodextrin in Timolol Liposomes for Decreasing and Prolonging Intraocular Pressure Levels

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