Clinical effectiveness of brinzolamide 1%–brimonidine 0.2% fixed combination for primary open-angle glaucoma and ocular hypertension

Abstract

The main first-line treatment strategy for glaucoma is to reduce intraocular pressure (IOP) by topical ocular hypotensive medications, but many patients require multiple medications for adequate IOP control. Fixed-combination therapies provide several benefits, including simplified treatment regimens, theoretical improved treatment adherence, elimination of the potential for washout of the first drug by the second, and the reduction in ocular exposure to preservatives. β-Adrenoceptor antagonists (particularly 0.5% timolol) are the most commonly used agents in combination with other classes of drugs as fixed-combination eyedrops, but they are contraindicated in many patients, owing to local allergy or systemic side effects. A fixed-combination preparation without a β-blocker is therefore warranted. This paper reviews the clinical effectiveness of brinzolamide 1% and brimonidine 0.2% fixed combination (BBFC) for use in patients with primary open-angle glaucoma and ocular hypertension. We searched PubMed and the ClinicalTrials.gov registry, and identified three randomized controlled trials comparing BBFC vs its constituents (brimonidine vs brinzolamide), and one comparing BBFC with unfixed brimonidine and brinzolamide. All of the studies demonstrated mean diurnal IOP to be statistically significantly lower in the BBFC group compared with constituent groups and noninferior to that with the concomitant group using two separate bottles. The safety profile of BBFC was consistent with that of its individual components, the most common ocular adverse events being ocular hyperemia, visual disturbances, and ocular allergic reactions. Common systemic adverse effects included altered taste sensation, oral dryness, fatigue, somnolence, and decreased alertness. BBFC seems to be a promising new fixed combination for use in glaucoma patients. However, long-term effects of BBFC on IOP, treatment adherence, and safety need to be determined.

Real-life experience of using brinzolamide/brimonidine fixed drop combination in a tertiary glaucoma centre

“…Third, our experience with the BBFC-related adverse events is somewhat different compared to the data published in short-term studies in which BBFC was a stand-alone medication or was added to a PG therapy [7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22]. In our investigation, 40.3% of the patients experienced at least one adverse event.…”

“…In the current investigation, we evaluated the IOPlowering efficacy and tolerance of BBFC on open- BBFC brinzolamide/brimonidine fixed combination, PG prostaglandin analogue, CAI topical carbonic anhydrase inhibitor In contrast to the previous studies in which BBFC was used as a stand-alone medication [7][8][9][10][11][12][13][14][15] or an adjunctive medication to PGs [16][17][18], our investigation reflects real-life clinical experience. Almost all our patients were difficult to control open-angle glaucoma cases on different complex topical medications with advanced disc damage and poor IOP control.…”

“…In the randomized prospective parallel group studies, the IOP-lowering efficacy of stand-alone BBFC ranged between 5.4 and 9.3 mmHg in openangle glaucoma and ocular hypertension [7][8][9][10][11][12][13][14][15]. The relative IOP reduction ranged between approximately 25% (trough efficacy) and 35% (peak efficacy).…”

A Phase III Randomized Clinical Trial of a 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination, Preservative-Free Ophthalmic Solution vs. 0.5% Timolol + 0.2% Brimonidine + 2.0% Dorzolamide Fixed Combination in Patients with Controlled Primary Open-Angle Glaucoma

“…However, monotherapy may be insufficient in many cases because of its inability to achieve the target IOP and/or prevent progression. In other cases, the drug applied may lose its effectiveness over time because of either tolerance or tachyphylaxis [ 9 ].…”

The role of fixed dose combinations in the treatment of primary open-angle glaucoma

“…Снижение уровня ВГД при использовании фиксированной комбинации составило 26,7-36,0%, при приеме бринзоламида -22,4-27,9%, бримонидина -20,6-31,3%, причем сниженные значения ВГД при инстилляциях препарата сохранялись на протяжении 24 ч [70,71,73]. В имеющихся обзорах подтвержден хороший профиль безопасности и переносимости фиксированной комбинации бринзоламид/бримонидин [72,73].…”