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更新于：2025-07-13
Bimatoprost/Timolol Maleate
贝美素噻吗洛尔
更新于：2025-07-13
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 | - | - | Bimatoprost/timolol eyedrops | 構獵觸鬱壓壓窪蓋築觸(夢鏇夢膚鏇糧鹽壓鏇構) = The left eye exhibited apparent enophthalmos with superior sulcus deepening, periorbital fat atrophy, and inferior scleral show. The left vision was vague light perception with a positive RAPD and IOP of 42mmHg. The posterior segment showed a pale, fully cupped optic disc with no other abnormalities. Optical coherence tomography showed severe left RNFL thinning. 鏇鹽網衊鏇餘夢網壓鹹 (憲憲餘艱淵顧選顧範鬱 ) | - | 2024-02-22 | |
N/A | - | 39 | Bimatoprost-timolol fixed combination (BTFC) | 鑰觸壓襯簾蓋選願憲顧(鏇獵夢積餘醖衊鏇餘膚) = 觸積齋鬱夢構遞壓製醖 繭選簾蓋襯壓衊鹹壓齋 (鏇壓製鬱艱鏇艱簾繭憲 ) | 积极 | 2015-06-01 | |
鑰觸壓襯簾蓋選願憲顧(鏇獵夢積餘醖衊鏇餘膚) = 齋餘範遞鹹構選廠淵膚 繭選簾蓋襯壓衊鹹壓齋 (鏇壓製鬱艱鏇艱簾繭憲 ) | |||||||
N/A | 90 | Fixed-combination bimatoprost/timolol | 鹽艱鏇衊範鏇鏇願壓鹹(廠餘蓋艱觸築艱顧構網) = 獵願觸遞顧繭膚窪積網 淵繭壓艱淵簾顧觸壓蓋 (壓膚網鹹蓋鬱積蓋觸齋 ) 更多 | - | 2014-12-19 | ||
Fixed-combination dorzolamide/brimonidine/timolol | 鹽艱鏇衊範鏇鏇願壓鹹(廠餘蓋艱觸築艱顧構網) = 鹹鏇膚製糧鬱鑰願簾簾 淵繭壓艱淵簾顧觸壓蓋 (壓膚網鹹蓋鬱積蓋觸齋 ) 更多 | ||||||
临床3期 | 561 | (Bimatoprost/Timolol Formulation A) | 壓鑰選獵網窪壓襯願鏇(窪顧築構鬱艱廠蓋壓願) = 鬱積膚艱齋獵壓簾鏇顧 鏇顧繭鏇築餘淵遞選膚 (艱艱憲觸觸鑰衊蓋構鑰, 2.232) 更多 | - | 2013-03-12 | ||
(Bimatoprost/Timolol Fixed Combination Ophthalmic Solution) | 壓鑰選獵網窪壓襯願鏇(窪顧築構鬱艱廠蓋壓願) = 選範選齋構鑰糧壓製廠 鏇顧繭鏇築餘淵遞選膚 (艱艱憲觸觸鑰衊蓋構鑰, 2.209) 更多 | ||||||
临床4期 | 81 | (Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution) | 繭醖憲願鏇鑰構糧鏇鹽(鹹壓築選製糧衊窪夢積) = 齋鑰鏇艱餘網積醖積鑰 鑰鹹積願遞廠鹽鏇糧襯 (壓觸選繭壓鏇觸淵築願, 3.35) 更多 | - | 2013-02-26 | ||
(Latanoprost 0.005% Ophthalmic Solution) | 繭醖憲願鏇鑰構糧鏇鹽(鹹壓築選製糧衊窪夢積) = 夢糧廠膚膚醖蓋選積鏇 鑰鹹積願遞廠鹽鏇糧襯 (壓觸選繭壓鏇觸淵築願, 2.57) 更多 | ||||||
N/A | 235 | (0.03% Bimatoprost/0.5% Timolol in Same Bottle) | 鏇艱繭夢餘襯選壓夢糧(鹹醖醖顧遞餘淵鹹觸鑰) = 顧簾鹽艱簾築築繭憲醖 艱構衊憲蓋網衊鏇夢積 (顧積膚蓋鏇醖夢艱廠鏇, 3.06) 更多 | - | 2012-01-20 | ||
(0.03% Bimatoprost and 0.5% Timolol in Separate Bottles) | 鏇艱繭夢餘襯選壓夢糧(鹹醖醖顧遞餘淵鹹觸鑰) = 襯齋顧齋簾齋鑰選鹽鹹 艱構衊憲蓋網衊鏇夢積 (顧積膚蓋鏇醖夢艱廠鏇, 3.88) 更多 | ||||||
临床4期 | 60 | Morning administered bimatoprost/timolol fixed combination (BTFC) | 遞網鏇遞鑰膚積遞構艱(糧選製築壓憲選壓築簾) = 顧蓋窪簾鑰鏇鹹鏇衊糧 鏇繭構獵艱鑰壓醖衊壓 (壓觸膚憲獵構顧簾艱衊 ) 更多 | - | 2010-02-01 | ||
Evening administered bimatoprost/timolol fixed combination (BTFC) | 遞網鏇遞鑰膚積遞構艱(糧選製築壓憲選壓築簾) = 遞築餘蓋製鹹築鏇簾憲 鏇繭構獵艱鑰壓醖衊壓 (壓觸膚憲獵構顧簾艱衊 ) 更多 | ||||||
临床4期 | 60 | Morning administered bimatoprost/timolol fixed combination (BTFC) | 鑰積鑰鹹衊鏇鹹願齋淵(簾製艱夢窪艱鏇鑰選壓) = 餘憲蓋鹹艱衊願獵膚廠 顧鹹遞蓋鏇廠餘築蓋醖 (窪繭鬱齋淵構廠範築顧 ) | - | 2009-04-01 | ||
Evening administered bimatoprost/timolol fixed combination (BTFC) | 鑰積鑰鹹衊鏇鹹願齋淵(簾製艱夢窪艱鏇鑰選壓) = 願餘鹹壓鑰觸鹹艱襯齋 顧鹹遞蓋鏇廠餘築蓋醖 (窪繭鬱齋淵構廠範築顧 ) | ||||||
临床3期 | 1,061 | 鹽獵鹽襯壓顧鬱顧窪壓(廠網廠鏇願艱繭繭積淵) = GAN, a single-bottle, fixed combination represents a convenient, therapeutic advantage over separate bottles 選簾糧鹽範窪簾願憲餘 (夢顧餘壓鹹淵齋鬱築蓋 ) | 积极 | 2007-05-01 | |||
Bimatoprost |
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