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更新于：2025-08-28
Bimatoprost/Timolol Maleate
贝美素噻吗洛尔
更新于：2025-08-28
概要
基本信息
药物类型 小分子化药 |
别名 Bimatoprost and Timolol Maleate、Bimatoprost/Timolol、Ganfort + [6] |
作用方式 激动剂、拮抗剂 |
作用机制 前列腺素类受体家族激动剂、β-adrenoceptors拮抗剂(β-肾上腺素能受体家族拮抗剂) |
治疗领域 |
非在研适应症- |
原研机构 |
非在研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C25H37NO4 |
InChIKeyAQOKCDNYWBIDND-FTOWTWDKSA-N |
CAS号155206-00-1 |
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关联
26
项与 贝美素噻吗洛尔 相关的临床试验CTRI/2021/04/033213
Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
NCT04898387
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
EUCTR2017-002823-46-AT
Efficacy and safety assessment of T4030 eye drops (unpreserved fixed combination of bimatoprost 0.01% and timolol 0.1% or 0.5%) versus Ganfort® UD (Unit Dose) in ocular hypertensive or glaucomatous patients.
100 项与 贝美素噻吗洛尔 相关的临床结果
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100 项与 贝美素噻吗洛尔 相关的转化医学
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100 项与 贝美素噻吗洛尔 相关的专利（医药）
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21
项与 贝美素噻吗洛尔 相关的文献（医药）2024-01-01Graefe's Archive for Clinical and Experimental Ophthalmology
MERCURY-3: a randomized comparison of netarsudil/latanoprost and bimatoprost/timolol in open-angle glaucoma and ocular hypertension
Article
作者: Lim, Kin Sheng ; Schweitzer, Cédric ; Fichtl, Marek ; Oddone, Francesco ; Belda, Jose I ; Stalmans, Ingeborg ; Laganovska, Guna ; Hommer, Anton ; Holló, Gábor ; Voykov, Bogomil ; Zarnowski, Tomasz
Abstract:
Purpose :
To compare the efficacy and safety of the fixed-dose combination (FDC) of netarsudil 0.02%/latanoprost 0.005% ophthalmic solution (NET/LAT; Roclanda®) with bimatoprost 0.03%/timolol maleate 0.5% (BIM/TIM; Ganfort®) ophthalmic solution in the treatment of open-angle glaucoma (OAG) and ocular hypertension (OHT).
Methods:
MERCURY-3 was a 6-month prospective, double–masked, randomized, multicenter, active-controlled, parallel-group, non-inferiority study. Patients (≥ 18 years) with a diagnosis of OAG or OHT in both eyes that was insufficiently controlled with topical medication (IOP ≥ 17 mmHg in ≥ 1 eye and < 28 mmHg in both eyes) were included. Following washout, patients were randomized to once-daily NET/LAT or BIM/TIM for up to 6 months; efficacy was assessed at Week 2, Week 4, and Month 3; safety was evaluated for 6 months. Comparison of NET/LAT relative to BIM/TIM for mean IOP at 08:00, 10:00, and 16:00 h was assessed at Week 2, Week 6, and Month 3. Non-inferiority of NET/LAT to BIM/TIM was defined as a difference of ≤ 1.5 mmHg at all nine time points through Month 3 and ≤ 1.0 mmHg at five or more of nine time points through Month 3.
Results:
Overall, 430 patients were randomized (NET/LAT, n = 218; BIM/TIM, n = 212), and all received at least one dose of study medication. Efficacy analyses were performed at Month 3 on 388 patients (NET/LAT, n = 184; BIM/TIM, n = 204). NET/LAT demonstrated non-inferiority to BIM/TIM, with a between-treatment difference in IOP of ≤ 1.5 mmHg achieved at all time points and ≤ 1.0 mmHg at the majority of time points (six of nine) through Month 3. Mean diurnal IOP during the study ranged from 15.4 to 15.6 mmHg and 15.2 to 15.6 mmHg in the NET/LAT and BIM/TIM groups respectively, with no between-group statistically significant difference. No significant differences were observed in key secondary endpoints. No serious, treatment-related adverse events (AEs) were observed, and AEs were typically mild/moderate in severity. The most common treatment-related AEs were conjunctival hyperemia (NET/LAT, 30.7%; BIM/TIM, 9.0%) and cornea verticillata (NET/LAT, 11.0%; BIM/TIM, 0%).
Conclusions:
Once-daily NET/LAT was non-inferior to BIM/TIM in IOP reduction in OAG and OHT, with AEs consistent with previous findings. NET/LAT offers a compelling alternative FDC treatment option for OAG and OHT.
2023-05-04Current medical research and opinion
A randomized clinical trial comparing three fixed combinations of bimatoprost with timolol in patients with open-angle glaucoma or ocular hypertension
Article
作者: Mrukwa-Kominek, Ewa ; Stalmans, Ingeborg ; Garhofer, Gerhard ; Misiuk-Hojlo, Marta ; Csutak, Adrienne
OBJECTIVE:
To compare the efficacy and safety of two fixed combination, preservative-free eye drops (bimatoprost 0.01% in combination with either timolol 0.1% or 0.5%) in a gel formulation, with bimatoprost 0.03%/timolol 0.5% in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
METHODS:
Phase II, randomized, investigator-masked, multicenter, 3-arm parallel group (Eudract No. 2017-002823-46). Eighty-six patients aged ≥18 years with OAG or OHT, with intraocular pressure (IOP) initially controlled for at least 6 months by a combination therapy of a dual prostaglandin and timolol or insufficiently controlled by first-line monotherapy were included. Patients were randomized to receive T4030a (bimatoprost 0.01%/timolol 0.1%; N = 29), T4030c (bimatoprost 0.01%/timolol 0.5%; N = 29) or bimatoprost 0.03%/timolol 0.5% (N = 28), administered once daily in the evening for 12 weeks. Primary endpoint was defined as change in IOP from day 1 to week 12 measured at 08:00 (±1 h). Further efficacy, safety and pharmacokinetic endpoints were assessed as secondary outcomes.
RESULTS:
The mean change in IOP from baseline to week 12 was -9.8 ± 2.1 mmHg for T4030a, -10.1 ± 2.5 mmHg for T4030c and -10.0 ± 2.8 mmHg for bimatoprost 0.03%/timolol 0.5%. All treatments were well tolerated with no safety issues identified in any group. In patients treated with T4030a, the systemic concentration of timolol was significantly lower after 12 weeks than in patients treated with T4030c or bimatoprost 0.03%/timolol0.5%.
CONCLUSIONS:
These study results suggest that the preservative-free ophthalmic formulation of T4030a (bimatoprost 0.01%/timolol 0.1%) can be regarded as a useful tool in the therapeutic management of OAG and OHT.
2023-02-01Ophthalmology and therapy
Safety of Fixed-Combination Bimatoprost 0.03%/Timolol 0.5% Ophthalmic Solution at 6 Months in Chinese Patients with Open-Angle Glaucoma or Ocular Hypertension
Article
作者: Yang, Jingyuan ; Duan, Xuanchu ; Goodkin, Margot L ; Xing, Xiaoli ; Chen, Michelle Y ; Yao, Ke ; Yu, Minbin ; Liu, Qinghuai ; Fang, Aiwu ; Sun, Xinghuai ; Zhang, Hong
INTRODUCTION:
Fixed-combination bimatoprost 0.03%/timolol 0.5% ophthalmic solution (FCBT; Ganfort®, Allergan, an AbbVie company) effectively reduces intraocular pressure (IOP) via complementary mechanisms of action of the agents, but long-term (> 12 weeks) safety evaluations of FCBT remain limited. FCBT safety is evaluated herein, with particular focus on hyperemia and eyelash growth, at 24 weeks in Chinese patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).
METHODS:
In this multicenter, open-label, noncomparative, phase 4 study conducted in China, patients diagnosed with OAG or OHT having insufficient response to β-blocker- or prostaglandin analogue/prostamide (PGA)-based IOP-lowering monotherapy in one or both eyes were switched from their current IOP-lowering treatment to FCBT (one drop per eye every evening) without prior washout. Assessment visits were scheduled at baseline and weeks 4, 12, and 24 (or study exit). The primary outcome measure was adverse event (AE) incidence through 24 weeks.
RESULTS:
Of 725 patients enrolled, 632 (87.2%) completed the study; 93 (12.8%) patients discontinued, including 29 (4.0%) due to AEs. Of 1326 FCBT-treated eyes (total), 594 (44.8%) experienced ≥ 1 ocular treatment-related AE during the study. Conjunctival hyperemia (the most common AE overall) and eyelash growth were reported in 269 (20.3%) and 54 (4.1%) FCBT-treated eyes, respectively. The incidence of other known PGA-related AEs (including blepharal pigmentation and erythema of eyelid) was < 10% each. Most conjunctival hyperemia reports were mild in severity (214/259; 82.6%) and only 1/259 (0.4%) was severe. Similarly, most cases of eyelash growth were mild (46/52; 88.5%); none were severe. One (< 0.1%) FCBT-treated eye had a serious ocular AE (OAG) considered FCBT-related.
CONCLUSIONS:
The frequency and severity of FCBT-related AEs, including conjunctival hyperemia and eyelash growth, are consistent with previously published findings. No new safety concerns were raised. This prospective study reaffirms that once-daily FCBT is a safe and well-tolerated therapy for OAG and OHT.
CLINICALTRIALS:
GOV IDENTIFIER:
NCT02571712.
100 项与 贝美素噻吗洛尔 相关的药物交易
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外链
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 开角型青光眼 | 欧盟 | 2006-05-19 | |
| 开角型青光眼 | 冰岛 | 2006-05-19 | |
| 开角型青光眼 | 列支敦士登 | 2006-05-19 | |
| 开角型青光眼 | 挪威 | 2006-05-19 | |
| 高眼压症 | 欧盟 | 2006-05-19 | |
| 高眼压症 | 冰岛 | 2006-05-19 | |
| 高眼压症 | 列支敦士登 | 2006-05-19 | |
| 高眼压症 | 挪威 | 2006-05-19 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 青光眼 | 临床3期 | 美国 | 2001-08-01 | |
| 青光眼 | 临床3期 | 加拿大 | 2001-08-01 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 90 | Fixed-combination bimatoprost/timolol | 襯網夢選鹹遞醖蓋構夢(艱積鬱積製願鏇鏇築鬱) = 鬱積鑰鑰鹹鹹廠鹹獵鬱 鏇艱鑰壓觸積鹽繭遞觸 (膚齋簾淵遞觸餘簾顧齋 ) 更多 | - | 2014-12-19 | ||
Fixed-combination dorzolamide/brimonidine/timolol | 襯網夢選鹹遞醖蓋構夢(艱積鬱積製願鏇鏇築鬱) = 廠製獵壓鹽鬱構餘糧淵 鏇艱鑰壓觸積鹽繭遞觸 (膚齋簾淵遞觸餘簾顧齋 ) 更多 | ||||||
临床3期 | 561 | (Bimatoprost/Timolol Formulation A) | 願願憲積壓簾築構膚獵(廠壓壓積鏇顧網淵構選) = 廠壓網窪壓獵憲壓鑰鹹 憲鹽網廠繭壓獵鑰壓鹹 (積淵鬱鹽壓製積鑰憲鑰, 2.232) 更多 | - | 2013-03-12 | ||
(Bimatoprost/Timolol Fixed Combination Ophthalmic Solution) | 願願憲積壓簾築構膚獵(廠壓壓積鏇顧網淵構選) = 鑰選積築遞製選願壓積 憲鹽網廠繭壓獵鑰壓鹹 (積淵鬱鹽壓製積鑰憲鑰, 2.209) 更多 | ||||||
临床4期 | 81 | (Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution) | 積糧觸鬱壓簾壓襯膚淵(蓋壓鏇淵選鏇遞願餘鬱) = 積憲醖觸鏇網顧鬱遞糧 構夢廠顧艱廠獵鑰範選 (築餘衊遞範襯廠簾網鑰, 3.35) 更多 | - | 2013-02-26 | ||
(Latanoprost 0.005% Ophthalmic Solution) | 積糧觸鬱壓簾壓襯膚淵(蓋壓鏇淵選鏇遞願餘鬱) = 繭鏇鏇製醖壓膚糧遞廠 構夢廠顧艱廠獵鑰範選 (築餘衊遞範襯廠簾網鑰, 2.57) 更多 | ||||||
N/A | 235 | (0.03% Bimatoprost/0.5% Timolol in Same Bottle) | 餘鑰齋淵鏇簾製齋構築(齋鏇選鏇網網範衊網範) = 繭鬱艱壓觸製艱願鹽醖 選觸齋餘觸襯鹹鏇網繭 (衊簾網鹽鹽遞鹹膚鹹顧, 3.06) 更多 | - | 2012-01-20 | ||
(0.03% Bimatoprost and 0.5% Timolol in Separate Bottles) | 餘鑰齋淵鏇簾製齋構築(齋鏇選鏇網網範衊網範) = 夢鬱願襯鬱鹹餘襯選糧 選觸齋餘觸襯鹹鏇網繭 (衊簾網鹽鹽遞鹹膚鹹顧, 3.88) 更多 | ||||||
临床4期 | 60 | Morning administered bimatoprost/timolol fixed combination (BTFC) | 淵積窪蓋鏇壓壓襯膚積(顧襯鹹範簾襯繭願鑰淵) = 憲鑰齋遞廠醖網願獵遞 壓醖衊衊壓齋鬱積艱範 (鹽繭鏇鏇積淵鏇艱鹽窪 ) 更多 | - | 2010-02-01 | ||
Evening administered bimatoprost/timolol fixed combination (BTFC) | 淵積窪蓋鏇壓壓襯膚積(顧襯鹹範簾襯繭願鑰淵) = 範積憲艱製觸鏇鑰鑰觸 壓醖衊衊壓齋鬱積艱範 (鹽繭鏇鏇積淵鏇艱鹽窪 ) 更多 | ||||||
临床4期 | 60 | Morning administered bimatoprost/timolol fixed combination (BTFC) | 夢淵範範糧廠獵獵願簾(膚膚夢齋廠齋築鏇鏇衊) = 餘遞壓鹹選齋鬱衊蓋簾 餘顧夢衊鏇壓鑰壓積鏇 (鏇範夢繭淵憲憲壓壓網 ) | - | 2009-04-01 | ||
Evening administered bimatoprost/timolol fixed combination (BTFC) | 夢淵範範糧廠獵獵願簾(膚膚夢齋廠齋築鏇鏇衊) = 積廠顧鬱襯顧簾襯鑰簾 餘顧夢衊鏇壓鑰壓積鏇 (鏇範夢繭淵憲憲壓壓網 ) | ||||||
临床3期 | 1,061 | 繭憲蓋鹽製醖蓋構齋構(窪選餘獵積觸遞廠積餘) = GAN, a single-bottle, fixed combination represents a convenient, therapeutic advantage over separate bottles 壓觸獵鑰簾築網鹽醖廠 (獵壓簾憲壓衊構蓋廠願 ) | 积极 | 2007-05-01 | |||
Bimatoprost |
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