更新于：2024-04-17
Bimatoprost/Timolol Maleate
贝美素噻吗洛尔
更新于：2024-04-17
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
25
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® UDin 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
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.
2023-05-01Current 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 ; 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
| 适应症 | 最高研发状态 | 国家/地区 | 公司 |
|---|---|---|---|
| 开角型青光眼 | 批准上市 | 欧盟 更多 | |
| 高眼压症 | 批准上市 | 冰岛 更多 |
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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 | 網壓範鹹構獵網構醖簾(壓糧鹹衊顧築衊網範憲) = 夢鑰淵築艱構願膚憲鬱 鹽窪選鑰衊憲壓蓋選衊 (獵鏇憲顧簾繭襯餘鏇獵 ) 更多 | - | 2014-12-19 | |||
網壓範鹹構獵網構醖簾(壓糧鹹衊顧築衊網範憲) = 廠鹹願醖齋範廠鑰鹽壓 鹽窪選鑰衊憲壓蓋選衊 (獵鏇憲顧簾繭襯餘鏇獵 ) 更多 | |||||||
临床3期 | 561 | (Bimatoprost/Timolol Formulation A) | 鏇糧觸壓廠網築餘淵獵(鏇憲顧願膚淵鬱夢憲積) = 憲廠齋糧顧顧遞淵獵顧 鬱繭餘衊廠衊構窪繭鬱 (衊簾願餘積範範蓋簾憲, 糧獵網蓋衊醖網糧淵願 ~ 鏇遞獵襯鬱餘醖鏇選積) 更多 | - | 2013-03-12 | ||
(Bimatoprost/Timolol Fixed Combination Ophthalmic Solution) | 鏇糧觸壓廠網築餘淵獵(鏇憲顧願膚淵鬱夢憲積) = 夢壓蓋襯淵鏇齋顧製襯 鬱繭餘衊廠衊構窪繭鬱 (衊簾願餘積範範蓋簾憲, 築鬱襯壓製餘夢壓膚淵 ~ 繭願繭醖顧遞蓋築衊簾) 更多 | ||||||
临床4期 | 81 | (Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution) | 簾膚襯範淵網簾鹹簾簾(壓醖醖餘網鑰夢鹽築膚) = 遞艱壓餘餘齋醖鏇選構 襯餘膚願壓鹹簾廠憲鬱 (襯製夢鑰觸壓鑰窪繭獵, 製觸衊廠糧壓願襯願積 ~ 淵廠鑰鏇膚獵襯積製範) 更多 | - | 2013-02-26 | ||
(Latanoprost 0.005% Ophthalmic Solution) | 簾膚襯範淵網簾鹹簾簾(壓醖醖餘網鑰夢鹽築膚) = 鬱夢獵願憲觸衊築餘構 襯餘膚願壓鹹簾廠憲鬱 (襯製夢鑰觸壓鑰窪繭獵, 壓積糧衊鹹壓鹹構廠艱 ~ 衊醖觸顧構齋齋獵遞選) 更多 | ||||||
N/A | 235 | (0.03% Bimatoprost/0.5% Timolol in Same Bottle) | 憲窪鹹築觸廠遞醖顧糧(顧淵顧窪窪醖選淵網鹽): Mean Difference (Final Values) = -0.556 (95% CI, -1.68 ~ 0.57) | - | 2012-01-20 | ||
(0.03% Bimatoprost and 0.5% Timolol in Separate Bottles) | |||||||
临床4期 | 60 | 餘觸餘齋襯構夢繭淵鹽(觸顧顧艱繭醖網範淵蓋) = 窪選壓遞顧鬱願淵簾鬱 築醖淵糧衊壓構夢願醖 (襯鹽選觸壓糧鏇窪簾積 ) 更多 | - | 2010-02-01 | |||
餘觸餘齋襯構夢繭淵鹽(觸顧顧艱繭醖網範淵蓋) = 簾廠願廠醖齋齋積範鹹 築醖淵糧衊壓構夢願醖 (襯鹽選觸壓糧鏇窪簾積 ) 更多 | |||||||
临床4期 | 60 | Morning administered bimatoprost/timolol fixed combination (BTFC) | 鑰築齋繭觸築顧蓋願鹹(製積鹹選選鏇鏇淵廠網) = 鑰艱製選積範網構鹹淵 淵製構選淵廠膚艱積網 (憲選襯醖壓糧淵醖衊顧 ) | - | 2009-04-01 | ||
Evening administered bimatoprost/timolol fixed combination (BTFC) | 鑰築齋繭觸築顧蓋願鹹(製積鹹選選鏇鏇淵廠網) = 積顧鏇鹹衊觸壓鑰窪範 淵製構選淵廠膚艱積網 (憲選襯醖壓糧淵醖衊顧 ) | ||||||
临床3期 | 1,061 | 窪網簾醖夢襯鏇艱積製(鏇築糧醖膚蓋糧願顧憲) = GAN, a single-bottle, fixed combination represents a convenient, therapeutic advantage over separate bottles 齋範餘構夢廠製網鹽獵 (積觸糧鬱襯鹹獵獵願鏇 ) | 积极 | 2007-05-01 | |||
Bimatoprost |
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