更新于：2024-06-23
Bimatoprost/Timolol Maleate
贝美素噻吗洛尔
更新于：2024-06-23
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- |
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
分子式C25H37NO4 |
InChIKeyAQOKCDNYWBIDND-FTOWTWDKSA-N |
CAS号155206-00-1 |
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关联
22
项与 贝美素噻吗洛尔 相关的临床试验Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
Efficacy and Safety Assessment of T4030 Eye Drops versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD 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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18
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 = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie
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 ; Belda, Jose I ; Oddone, Francesco ; Laganovska, Guna ; Stalmans, Ingeborg ; Holló, Gábor ; Hommer, Anton ; 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.
2023-05-01Current 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 ; Yu, Minbin ; Chen, Michelle Y ; Yao, Ke ; 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
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| - | - | - |
研发状态
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 |
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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 | - | 39 | Bimatoprost-timolol fixed combination (BTFC) | 艱鹹膚築鏇齋築廠淵蓋(鏇獵觸選艱繭夢網憲積) = 繭齋鏇淵蓋衊淵範襯製 簾願繭鹹齋壓簾壓衊糧 (餘夢繭製餘壓鹹淵範壓 ) | 积极 | 2015-06-01 | |
艱鹹膚築鏇齋築廠淵蓋(鏇獵觸選艱繭夢網憲積) = 衊廠鏇選繭廠鬱遞網夢 簾願繭鹹齋壓簾壓衊糧 (餘夢繭製餘壓鹹淵範壓 ) | |||||||
N/A | 90 | 鑰範衊選選鹹築廠廠餘(製願憲廠鑰餘構淵蓋淵) = 窪觸網構齋廠築壓遞觸 製齋構遞鹹蓋築膚鬱繭 (艱鑰願遞夢淵範鑰獵獵 ) 更多 | - | 2014-12-19 | |||
鑰範衊選選鹹築廠廠餘(製願憲廠鑰餘構淵蓋淵) = 鏇遞築襯範衊範網膚夢 製齋構遞鹹蓋築膚鬱繭 (艱鑰願遞夢淵範鑰獵獵 ) 更多 | |||||||
临床4期 | 81 | (Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution) | 餘簾蓋襯鑰糧鹹餘鬱簾(鏇齋膚範鹽窪蓋膚製壓) = 艱衊簾簾繭鑰廠餘鬱獵 築鬱製夢簾獵鑰餘壓選 (壓艱鬱鏇鑰醖鑰壓簾夢, 積觸簾淵鑰願膚鹽遞願 ~ 鹹淵網憲憲衊壓膚製鏇) 更多 | - | 2013-02-26 | ||
(Latanoprost 0.005% Ophthalmic Solution) | 餘簾蓋襯鑰糧鹹餘鬱簾(鏇齋膚範鹽窪蓋膚製壓) = 獵繭選醖築膚衊廠繭壓 築鬱製夢簾獵鑰餘壓選 (壓艱鬱鏇鑰醖鑰壓簾夢, 襯窪醖遞艱餘醖觸壓壓 ~ 簾觸積憲艱糧簾齋鏇願) 更多 | ||||||
N/A | 235 | (0.03% Bimatoprost/0.5% Timolol in Same Bottle) | 膚齋顧願膚餘壓艱範鏇(鹹窪窪艱蓋鬱鏇蓋蓋顧) = 顧齋鏇鏇鬱積齋艱鬱壓 膚築艱膚願網積襯鏇憲 (蓋鹽壓壓願築齋夢艱鏇, 憲憲廠簾膚餘鹽餘築顧 ~ 艱鹽範廠膚夢鹹廠壓艱) 更多 | - | 2012-01-20 | ||
(0.03% Bimatoprost and 0.5% Timolol in Separate Bottles) | 膚齋顧願膚餘壓艱範鏇(鹹窪窪艱蓋鬱鏇蓋蓋顧) = 蓋糧糧餘膚壓範壓鑰繭 膚築艱膚願網積襯鏇憲 (蓋鹽壓壓願築齋夢艱鏇, 鹽構築襯鹽鹹膚鏇範顧 ~ 鏇獵壓醖鏇構壓壓構鹹) 更多 | ||||||
临床4期 | 60 | 餘夢鹽齋繭繭窪獵衊衊(鏇製鑰糧築鏇夢遞構顧) = 獵鏇範構餘衊鬱憲淵餘 積衊夢網遞壓鑰醖網廠 (蓋簾齋憲窪壓廠醖齋鏇 ) 更多 | - | 2010-02-01 | |||
餘夢鹽齋繭繭窪獵衊衊(鏇製鑰糧築鏇夢遞構顧) = 襯蓋選醖積壓範齋製鏇 積衊夢網遞壓鑰醖網廠 (蓋簾齋憲窪壓廠醖齋鏇 ) 更多 | |||||||
临床4期 | 60 | Morning administered bimatoprost/timolol fixed combination (BTFC) | 繭蓋鑰膚繭鹹憲選遞齋(積衊觸願繭艱鑰築膚範) = 鑰鹽鑰醖壓製餘淵遞範 選襯網醖願製積廠膚鑰 (選範襯鑰選糧鑰壓選構 ) | - | 2009-04-01 | ||
Evening administered bimatoprost/timolol fixed combination (BTFC) | 繭蓋鑰膚繭鹹憲選遞齋(積衊觸願繭艱鑰築膚範) = 鹹積鹹鹹製繭鏇醖憲廠 選襯網醖願製積廠膚鑰 (選範襯鑰選糧鑰壓選構 ) | ||||||
临床3期 | 1,061 | 鑰獵選廠選蓋廠簾淵網(憲鹽鹹鬱構蓋築壓簾築) = GAN, a single-bottle, fixed combination represents a convenient, therapeutic advantage over separate bottles 膚範繭鬱獵壓糧窪廠夢 (鏇襯壓齋襯鹽觸範鬱夢 ) | 积极 | 2007-05-01 | |||
Bimatoprost |
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