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.

开始日期2018-09-11

申办/合作机构

Laboratoires Théa SAS

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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项与贝美素噻吗洛尔相关的文献（医药）

2024-01-01·Graefe'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.

2023-05-04·Current 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.

2023-02-01·Ophthalmology 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.

项与贝美素噻吗洛尔相关的新闻（医药）

2025-04-28

·药时代

28.4亿美元！4月中国创新药出海汇总

据药时代不完全统计，2025年4月中国医药BD出海交易共计5笔，已披露首付款共计1.52亿美元，总金额28.4亿美元，环比3月份的121.25亿美元，显著降低。恒瑞医药4月7日，恒瑞与德国默克达成合作，后者获得SHR7280在中华人民共和国大陆地区（不包含香港、澳门特别行政区和台湾）商业化的独家权利以及SHR7280在授权区域之外区域的优先谈判权。恒瑞则获得1500万欧元的首付款，并且产品在获得中国药监局批准后，恒瑞有资格获得一定的里程碑付款，同时默克将向恒瑞支付达到实际年净销售额两位数的销售提成。兆科眼科4月16日，兆科眼科与Interpharma Public Company Limited就于泰国商业化NVK002（一种控制近视加深的创新疗法）；BRIMOCHOL™PF（一种治疗老花眼的创新药物）；以及六款针对青光眼的仿制药（贝美前列素、贝美素噻吗洛尔、拉坦前列素、拉坦噻吗、曲伏前列素及曲伏噻吗）分别订立三份分销及供应协议。根据协议条款，兆科眼科将授予Interpharma于泰国进口、分销、推广、营销及销售该等产品的独家权利。Interpharma将代表兆科眼科取得相关的当地药物注册。该等已签订的协议将让兆科眼科可获得不可退还、不可抵扣的预付款项及按照若干成就获得额外里程碑付款。华深智药4月17日，华深智药子公司Earendil Labs与赛诺菲就两种潜在的首创双特异性抗体达成许可协议，用于自身免疫性和炎症性肠病领域。根据协议，赛诺菲将获得两种双特异性抗体 HXN-1002 和 HXN-1003 的全球独家授权，这两种抗体均将利用 Earendil Labs 专有的人工智能和高通量发现与研究平台进行开发。作为协议的一部分，Earendil Labs 将获得 1.25 亿美元的预付款，并有资格获得总计高达 17.2 亿美元的开发和商业里程碑付款，其中包括 5000 万美元的近期付款。此外，Earendil Labs 有资格获得从高个位数到低两位数不等的产品销售额的分级版税。橙帆医药4月18日，橙帆医药与美国Ollin Biosciences就自主研发的双特异性抗体药物VBS-102达成全球独家授权协议。Ollin获得该药物在大中华区以外的全球开发、生产及商业化权益，橙帆医药保留大中华区权益。根据协议条款，本次交易总金额最高可达4.4亿美元，包含首付款、开发、注册及商业化里程碑付款。此外，橙帆医药将获得授权区域销售的分级特许权使用费。荃信生物4月24日，荃信生物宣布与Caldera Therapeutics达成合作，后者获得临床前阶段长效自免双抗QX030N开发及商业化的全球独家许可。作为回报，荃信生物或其指定联属公司将获得1000万美元一次性、不可退还及不可抵扣的预付款及Caldera约24.88%的股权；在达成特定临床开发、监管及商业里程碑的前提下，荃信生物还可获得最多5.45亿美元的额外付款；此外，荃信生物有权在QX030N首次商业销售后的一段特定时间内收取销售净额的分级特许权使用费。海外获批上市概况据药时代不完全统计，4月共有14家药企宣布旗下产品实现海外获批上市，大部分仍是原料药出海。其中，正大天晴/康方生物的PD-1派安普利单抗为创新药出海。4月25日，安尼可（派安普利单抗注射液）已获得美国FDA批准上市，用于治疗复发或转移性鼻咽癌（NPC）的一线治疗和以铂类为基础的至少一线化疗治疗进展后治疗的2项适应证。截至日前，中国PD-1在美获批数量达到三款，分别来自百济、君实、正大天晴/康方。小结2025年一季度国内创新药企的出海表现令人瞩目，33笔交易，已披露金额超362亿美元。其中，单就启德医药的大宗商务战略合作（超130亿美元）就超过了本月授权出海总额。其次，第一季度中ADC为出海主力，8笔交易，已披露金额达165.27亿美元。而4月，双抗为出海主力，5笔交易中有3笔为双抗。值得一提的是，目前AACR年会正在举行，中国的多特异性抗体颇为亮眼，尤其是在2024年世界肺癌大会（WCLC）康方宣布旗下依沃西单抗（PD-1/VEGF双抗）在HARMONi-2研究中头对头击败药王K药之后，中国多抗的吸引力再度飙升。期待本届AACR年会结束后能有相关交易达成。图片来源：正文关税阴云下，大型药企并购热情不减，哪些中国药企可能被收购？2025-04-27脑癌无情，科学有爱：这位全球知名肿瘤医生以身试药，为革命性药物 “打样”2025-04-26FDA批准73款生物类似药，仅66%商业化！从修美乐看市场困境2025-04-25版权声明/免责声明本文为汇编文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢!药时代官方网站:www.drugtimes.cn联系方式:电话:13651980212微信:27674131邮箱:contact@drugtimes.cn点击这里，查看更多精彩!

引进/卖出

2025-04-17

·Pharma CMC

兆科眼科将8款眼科产品商业化权益授权Interpharma

4月16日，兆科眼科发布公告，公司已与Interpharma Public Company Limited就于泰国商业化NVK002（一种控制近视加深的创新疗法）；BRIMOCHOL™PF（一种治疗老花眼的创新药物）；以及六款针对青光眼的仿制药（贝美前列素、贝美素噻吗洛尔、拉坦前列素、拉坦噻吗、曲伏前列素及曲伏噻吗）分别订立三份分销及供应协议。根据协议条款，兆科眼科将授予Interpharma于泰国进口、分销、推广、营销及销售该等产品的独家权利。Interpharma将代表兆科眼科取得相关的当地药物注册。该等已签订的协议将让兆科眼科可获得不可退还、不可抵扣的预付款项及按照若干成就获得额外里程碑付款。NVK002是一种用于控制儿童及青少年近视加深的试验性新型外用眼部溶液。NVK002是一项专利配方，成功解决低浓度阿托品的不稳性，此技术在全球均受到知识产权保护。NVK002不含防腐剂，预计保存期逾24个月。BRIMOCHOL™PF为不含防腐剂的每日一次瞳孔调节滴眼液，用于矫正因老花眼而丧失近距离视力的疗法。BRIMOCHOL™PF为固定剂量卡巴胆碱（胆碱制剂）及酒石酸溴莫尼丁（α2－受体促效剂）复方。BRIMOCHOL™PF令瞳孔收缩，产生「针孔效应」，仅让在中央聚焦的光线进入眼球，从而使中短距离的影像更锐利。贝美前列素为一种前列腺素类似物（PGA），用于治疗开角型青光眼及高眼压症。兆科眼科已开发出不含防腐剂的单一剂量贝美前列素滴眼液，为艾伯维旗下Lumigan的仿制药，亦为获中国批准的首款不含防腐剂的单一剂量贝美前列素滴眼液。贝美素噻吗洛尔为一种固定剂量组合滴眼液，含PGA及β受体拮抗剂，可降低眼压。该滴眼液为单药应答不佳或不足的原发性开角型青光及高眼压患者的替代疗法。该药具有多重降眼压途径，可以使对仅含PGA或β受体拮抗剂的滴眼液应答不足的患者实现目标眼压。拉坦前列素为一种PGA单一疗法滴眼液，用于治疗开角型青光眼及高眼压症。根据灼识的资料，拉坦前列素为中国用于治疗开角型青光眼的最常用PGA处方药之一。拉坦噻吗为一种组合PGA及β受体拮抗剂滴眼液，可降低眼压。拉坦噻吗滴眼液为耐药性开角型青光眼的替代疗法。该药具有双重作用机制，可以使对仅含PGA或β受体拮抗剂的滴眼液应答不足的患者实现目标眼压。曲伏前列素为一种PGA单一疗法滴眼液，用于治疗开角型青光眼及高眼压症。根据灼识的资料，曲伏前列素为中国用于治疗开角型青光眼的最常用PGA处方药。曲伏噻吗为一种组合PGA及β受体拮抗剂滴眼液，可降低开角型青光眼或高眼压症成年患者的眼压。曲伏噻吗滴眼液为单药无法达到理想眼压降低效果的开角型青光眼患者的替代疗法。该药具有双重作用机制，可以使对仅含PGA或β受体拮抗剂的滴眼液应答不足的患者的眼压进一步降低。Interpharma由一个拥有丰富药业经验的医疗专业人士团体成立。该团体由全球领先制药公司的前董事、医师、药剂师、营养师及医疗技术人员组成。Interpharma拥有丰富而悠久的药业经验，在医院营养保健品方面名列第一。

引进/卖出

2024-11-22

·米内网

10亿眼科明星药集采止跌！TOP20洗牌，康弘、兴齐……国产品牌突围，恒瑞、信达新药来袭

精彩内容近期，眼科用药市场波澜再起。成都康弘药业集团的玻璃酸钠滴眼液、苏州乐珠制药的盐酸氮䓬斯汀滴眼液等4个产品同日获批。今年以来，眼科用药已有20个品种（133个受理号）获批上市。米内网数据显示，眼科用药在近年中国公立医疗机构终端销售规模均超过100亿元，2024年上半年同比下滑6.21%。5个国采品种中仅玻璃酸钠滴眼液正增长，从TOP20来看，康柏西普眼用注射液领跑，康弘、兴齐等国产品牌突围。眼科用药有52个品种（270个受理号）报产在审，辰欣佛都药业、扬州中宝药业等企业冲击首仿，5个新药亮眼。 4个眼科用药同日获批，兴齐、齐鲁、万汉制药领跑过评榜 11月以来眼科用药获批情况来源：米内网中国申报进度（MED）数据库 11月21日，国家药监局官网显示，华熙生物科技的玻璃酸钠滴眼液、成都康弘药业集团的玻璃酸钠滴眼液、苏州乐珠制药的盐酸氮䓬斯汀滴眼液和地夸磷索钠滴眼液同日获批，视同过评。在此之前，妥布霉素滴眼液第2家过评企业诞生，苏州乐珠制药和浙江莎普爱思药业均以仿制4类报产同日获批，视同过评。今年以来，眼科用药已有20个品种（133个受理号）获批上市，数量超过2023年全年。过评企业数10家及以上的眼科用药来源：米内网中国申报进度（MED）数据库截至目前，眼科用药有24个品种（256个品规）过评，7个品种有10家及以上企业过评，其中，玻璃酸钠滴眼液（41家）最为火热，其次是盐酸莫西沙星滴眼液（40家）、地夸磷索钠滴眼液（30家）。 8个品种独家过评，分别为成都普什制药的氯化钠滴眼液、沈阳兴齐眼药的环孢素滴眼液(Ⅱ)、四川禾亿制药的盐酸利多卡因眼用凝胶、兆科(广州)眼科药物的贝美素噻吗洛尔滴眼液、Maxmind的拉坦前列素滴眼液、汇禹远和(海南)药业的复方托吡卡胺滴眼液、山东绅联药业的盐酸环喷托酯滴眼液、苏州欧康维视生物的盐酸西替利嗪滴眼液，其中，山东绅联药业的盐酸环喷托酯滴眼液和苏州欧康维视生物的盐酸西替利嗪滴眼液均在今年获批。过评5个及以上眼科用药的集团来源：米内网中国申报进度（MED）数据库从集团过评品种数来看，沈阳兴齐眼药、齐鲁制药、中山万汉制药领跑，各有8个；远大健康、成都普什制药、欧康维视生物各有6个；扬子江药业、众生药业、莎普爱思药业、苏州乐珠制药等6家各有5个。 10亿明星药集采止跌！TOP20洗牌，康弘、兴齐……国产品牌突围米内网数据显示，近年中国公立医疗机构终端眼科用药（化学药+生物药）销售规模均超过100亿元，2024年上半年同比下滑6.21%，眼部血管病变治疗药、抗感染药、抗炎药是3大畅销小类。2024年上半年中国公立医疗机构终端眼科用药TOP5集团来源：米内网中国公立医疗机构药品终端竞争格局从集团格局来看，诺华集团、康弘药业、参天制药、沈阳兴齐眼药、拜耳位居前五，其中，康弘药业和沈阳兴齐眼药两家国内药企逆势上扬，销售额增速分别为25.74%和4.82%。 2024年上半年中国公立医疗机构终端眼科用药产品TOP20来源：米内网中国公立医疗机构药品终端竞争格局产品TOP20中，13个产品销售额超过1亿元，康柏西普眼用注射液是超10亿元的重磅品种，右旋糖酐羟丙甲纤维素滴眼液为新上榜产品。从在销企业数来看，妥布霉素滴眼液最多，有21家；其次是玻璃酸钠滴眼液和左氧氟沙星滴眼液均超过10家。目前，眼科用药已有5个产品纳入国采，左氧氟沙星滴眼液（第三批）、玻璃酸钠滴眼液（第四批）、地夸磷索钠滴眼液（第九批）均在产品TOP20之列。5个集采产品中仅有玻璃酸钠滴眼液正增长，4个产品均有下滑，地夸磷索钠滴眼液跌幅最大。近年中国公立医疗机构终端玻璃酸钠滴眼液销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局玻璃酸钠滴眼液在中国公立医疗机构终端销售额峰值超过10亿元，受集采影响连续下滑后，2023年止跌回升，2024年上半年同比增长近5%，是眼科用药TOP3产品。该产品目前有54家企业拥有生产批文，参天制药、URSAPHARM、成都普什制药的市场份额位居前三。 2024年上半年中国公立医疗机构终端眼科用药品牌TOP20来源：米内网中国公立医疗机构药品终端竞争格局品牌TOP20中，成都康弘生物的康柏西普眼用注射液、诺华的雷珠单抗注射液、拜耳的阿柏西普眼内注射溶液位居前三，爱尔康的右旋糖酐羟丙甲纤维素滴眼液和沈阳兴齐眼药的加替沙星眼用凝胶则是新上榜品牌。 4个品牌增速超过20%，其中，成都康弘生物的康柏西普眼用注射液、沈阳兴齐眼药的环孢素滴眼液(Ⅱ)、珠海亿胜生物制药的牛碱性成纤维细胞生长因子滴眼液3个均是独家产品。从品牌数量来看，诺华最多，有4个上榜；参天制药和沈阳兴齐眼药各有2个上榜。辰欣、兆科……冲击首仿，恒瑞、信达新药来袭 11月22日，CDE官网显示，江苏福邦药业的玻璃酸钠滴眼液以仿制4类报产在审。在此之前，辰欣佛都药业的盐酸奥布卡因滴眼液、深圳市宇健生物医药|中山万汉制药的地夸磷索钠滴眼液同日报产在审。截至目前，眼科用药有52个品种（270个受理号）报产在审，地夸磷索钠滴眼液最火，有27家企业，其次是玻璃酸钠滴眼液，有20家。从企业数量来看，14家企业有5个及以上产品报产在审，其中，莎普爱思药业和宁波视方医药科技各有7个，沈阳兴齐眼药、兆科药业、石家庄格瑞药业等8家各有6个。国内无仿制药获批且报产在审的眼科用药来源：米内网中国申报进度（MED）数据库曲伏噻吗滴眼液、氟比洛芬钠滴眼液、盐酸依匹斯汀滴眼液等眼科用药国内暂无仿制药获批，辰欣佛都药业、扬州中宝药业、兆科(广州)眼科药物等企业有望拿下首仿。眼科用药新药报产在审情况来源：米内网中国申报进度（MED）数据库此外，信达生物制药(苏州)的替妥尤单抗注射液、山东博安生物技术的阿柏西普眼内注射溶液等5个眼科用药新药报产在审，其中，成都盛迪医药的SHR8058滴眼液为化药1类新药。资料来源：国家药监局官网、米内网数据库等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准一致性评价医药出海

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
-	-	S01ED51	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
开角型青光眼	欧盟	AbbVie Deutschland GmbH & Co. KG	2006-05-19
开角型青光眼	冰岛	AbbVie Deutschland GmbH & Co. KG	2006-05-19
开角型青光眼	列支敦士登	AbbVie Deutschland GmbH & Co. KG	2006-05-19
开角型青光眼	挪威	AbbVie Deutschland GmbH & Co. KG	2006-05-19
高眼压症	欧盟	AbbVie Deutschland GmbH & Co. KG	2006-05-19
高眼压症	冰岛	AbbVie Deutschland GmbH & Co. KG	2006-05-19
高眼压症	列支敦士登	AbbVie Deutschland GmbH & Co. KG	2006-05-19
高眼压症	挪威	AbbVie Deutschland GmbH & Co. KG	2006-05-19

未上市

10 条进展最快的记录,

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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	Allergan UC	2001-08-01
青光眼	临床3期	加拿大	Allergan UC	2001-08-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


APAO2024	N/A	-	-	Bimatoprost/timolol eyedrops	繭遞膚顧艱選鹽衊鹽範(蓋壓鏇選蓋窪淵遞襯獵) = 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. 繭願醖壓網夢積醖艱顧 (艱窪鏇膚廠淵製糧淵鑰 )	-	2024-02-22
ARVO2015	N/A	-	39	Bimatoprost-timolol fixed combination (BTFC)	遞廠鹽鑰夢淵鹹顧衊鏇(鹹淵範餘蓋鹽廠築築構) = 繭鑰廠積衊遞網遞艱積蓋蓋繭艱齋廠蓋糧觸築 (觸鏇積艱選齋糧繭憲構 )	积极	2015-06-01
				Latanoprost	遞廠鹽鑰夢淵鹹顧衊鏇(鹹淵範餘蓋鹽廠築築構) = 範鑰遞衊顧鏇網淵繭顧蓋蓋繭艱齋廠蓋糧觸築 (觸鏇積艱選齋糧繭憲構 )
NCT01737853 (Pubmed)	N/A	开角型青光眼 \| 高眼压症	90	Fixed-combination bimatoprost/timolol	簾鹹選製範鹹窪選艱餘(製範願簾糧顧窪衊衊選) = 選餘鬱壓製顧壓製糧艱積餘淵遞鹽襯積蓋構衊 (鏇醖網襯觸範廠顧蓋蓋 ) 更多	-	2014-12-19
				Fixed-combination dorzolamide/brimonidine/timolol	簾鹹選製範鹹窪選艱餘(製範願簾糧顧窪衊衊選) = 獵憲築範範蓋淵築鹹膚積餘淵遞鹽襯積蓋構衊 (鏇醖網襯觸範廠顧蓋蓋 ) 更多
NCT01177098 (CTgov)	临床3期	青光眼	561	bimatoprost /timolol formulation A fixed combination ophthalmic solution (Bimatoprost/Timolol Formulation A)	積遞襯範醖獵鹹製廠艱(願顧積壓繭範築廠淵顧) = 範鏇壓鬱築襯襯顧繭廠願鏇襯蓋襯壓鬱鏇衊襯 (鹽廠糧願網膚餘壓膚淵, 2.232) 更多	-	2013-03-12
				bimatoprost/timolol fixed combination ophthalmic solution (Bimatoprost/Timolol Fixed Combination Ophthalmic Solution)	積遞襯範醖獵鹹製廠艱(願顧積壓繭範築廠淵顧) = 鏇衊網選淵膚夢蓋鏇餘願鏇襯蓋襯壓鬱鏇衊襯 (鹽廠糧願網膚餘壓膚淵, 2.209) 更多
NCT01243567 (CTgov)	临床4期	开角型青光眼	81	bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution)	艱築衊積製構廠鑰襯膚(獵廠觸鬱窪襯淵觸餘範) = 簾鹹壓壓糧壓獵窪顧齋網繭餘顧衊廠淵鏇膚構 (選鏇醖鏇遞範蓋窪網網, 3.35) 更多	-	2013-02-26
				latanoprost 0.005% ophthalmic solution (Latanoprost 0.005% Ophthalmic Solution)	艱築衊積製構廠鑰襯膚(獵廠觸鬱窪襯淵觸餘範) = 繭獵鹽壓憲顧糧願願淵網繭餘顧衊廠淵鏇膚構 (選鏇醖鏇遞範蓋窪網網, 2.57) 更多
NCT01068964 (CTgov)	N/A	开角型青光眼	235	0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution (0.03% Bimatoprost/0.5% Timolol in Same Bottle)	憲壓簾鬱糧網艱窪淵顧(衊膚選積糧鏇醖壓膚選) = 簾醖繭製顧觸鏇獵網遞製構網願範壓鹽醖遞襯 (願廠齋衊憲製製廠壓齋, 3.06) 更多	-	2012-01-20
				0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution (0.03% Bimatoprost and 0.5% Timolol in Separate Bottles)	憲壓簾鬱糧網艱窪淵顧(衊膚選積糧鏇醖壓膚選) = 衊鹹鬱鹹製獵簾壓窪艱製構網願範壓鹽醖遞襯 (願廠齋衊憲製製廠壓齋, 3.88) 更多
NCT00486486 (Pubmed \| Br J Ophthalmol)	临床4期	青光眼	60	Morning administered bimatoprost/timolol fixed combination (BTFC)	築繭醖襯窪膚淵蓋製醖(襯鑰餘獵淵餘遞糧蓋鏇) = 醖鬱襯鑰築淵築艱願網鏇壓膚顧鏇積糧網艱獵 (構壓繭簾壓願壓艱憲壓 ) 更多	-	2010-02-01
				Evening administered bimatoprost/timolol fixed combination (BTFC)	築繭醖襯窪膚淵蓋製醖(襯鑰餘獵淵餘遞糧蓋鏇) = 觸顧膚憲齋齋觸鬱鏇構鏇壓膚顧鏇積糧網艱獵 (構壓繭簾壓願壓艱憲壓 ) 更多
NCT00486486 (ARVO2009)	临床4期	青光眼	60	Morning administered bimatoprost/timolol fixed combination (BTFC)	齋獵繭艱構窪窪網築鏇(鬱衊遞艱膚鹽鏇獵膚餘) = 積構鑰壓繭簾衊範壓鹹憲夢簾遞築衊繭醖簾艱 (築顧鬱遞夢壓築網網鬱 )	-	2009-04-01
				Evening administered bimatoprost/timolol fixed combination (BTFC)	齋獵繭艱構窪窪網築鏇(鬱衊遞艱膚鹽鏇獵膚餘) = 壓積鏇願壓餘衊繭獵遞憲夢簾遞築衊繭醖簾艱 (築顧鬱遞夢壓築網網鬱 )
NCT00332540 \| NCT00332072 (ARVO2007)	临床3期	高眼压症 \| 青光眼	1,061	Bimatoprost/timolol Fixed Combination	齋範繭網壓製廠願築觸(鹽鑰鏇憲範鑰鏇鑰衊鬱) = GAN, a single-bottle, fixed combination represents a convenient, therapeutic advantage over separate bottles 襯襯顧淵範淵膚餘範簾 (廠餘淵顧鬱獵顧鹹願製 )	积极	2007-05-01
				Bimatoprost