酒石酸溴莫尼定(Brimonidine Tartrate) - 药物靶点：ADRA2_在研适应症：眼睛发红，玫瑰痤疮，青光眼_专利_临床

概要

基本信息

药物类型

小分子化药

别名

5-Bromo-6-(2-imidazolin-2-ylamino)quinoxaline、BRIMONIDINE、Brimonidine tartrate (JAN/USAN)

+ [29]

靶点

ADRA2

作用机制

ADRA2激动剂(肾上腺素能受体α-2家族激动剂)

治疗领域

眼部疾病皮肤和肌肉骨骼疾病免疫系统疾病

在研适应症

眼睛发红玫瑰痤疮青光眼+ [7]

非在研适应症

年龄相关性黄斑变性红斑地图样萎缩+ [5]

原研机构

Allergan Ltd. (Ireland)

在研机构

Bausch & Lomb, Inc.Tarian PharmaAllergan, Inc.

+ [8]

非在研机构

Allergan Ltd. (Ireland)oOh!media Group Pty Ltd.

Actavis, Inc.

最高研发阶段批准上市

首次获批日期

美国 (1996-09-06),

开角型青光眼高眼压症

最高研发阶段(中国)批准上市

特殊审评孤儿药 (美国)

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结构/序列

分子式C15H16BrN5O6

InChIKeyQZHBYNSSDLTCRG-LREBCSMRSA-N

CAS号70359-46-5

关联

134

项与酒石酸溴莫尼定相关的临床试验

NCT04007276

/ Not yet recruiting临床4期IIT

The Effect of Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) on Ocular Redness, Intraocular Pressure, and Eyelid Position in Glaucoma Patients Using Brimonidine 0.2%, 0.15%, or 0.1%

Glaucoma represents a group of conditions that cause damage to the optic nerve and can lead to irreversible vision loss. Current treatments are aimed at lowering intraocular pressure while minimizing medication side effects. Lumify™ (Brimonidine Tartrate Ophthalmic Solution 0.025%) is an FDA-approved medication for alleviating eye redness, a common side effect of glaucoma medications. The purpose of this study is to evaluate the effect of Lumify™ on eye redness, intraocular pressure, and eyelid position in patients with glaucoma who are already using the Brimonidine 0.1%, 0.15% or 0.2% eye drops.

开始日期2025-11-10

申办/合作机构-

NCT06818058

/ Recruiting临床2期

A Phase II Multicentric, Randomized, Double-blind, Placebo-controlled Study of TAR-0520 Gel in EGFR Inhibitor-induced Folliculitis.

A Phase II, multicentric, randomized, double-blind, placebo-controlled, parallel- group trial to confirm the good safaty profile and to explore the preventive effect of topically applied TAR-0520 gel on folliculitis developed in metastatic colorectal cancer (mCRC) patients treated with monoclonal anti-EGFR antibodies.

开始日期2025-01-20

申办/合作机构

Tarian Pharma

IRCT20240217061030N2

/ Recruiting临床2/3期IIT

Ocular Hypotensive effects of topical versus sublingual brimonidine: a cross-over study

开始日期2024-11-13

申办/合作机构

Shahid Beheshti University of Medical Sciences

100 项与酒石酸溴莫尼定相关的临床结果

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100 项与酒石酸溴莫尼定相关的转化医学

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100 项与酒石酸溴莫尼定相关的专利（医药）

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2,892

项与酒石酸溴莫尼定相关的文献（医药）

2025-02-01·Ophthalmology and Therapy

Randomized Clinical Trial of Intraocular Pressure-Lowering Medications on Preventing Spikes in Intraocular Pressure Following Intravitreal Anti-Vascular Endothelial Growth Factor Injections

Article

作者: Seekhum, Natthapuch ; Sathim, Wanwisa ; Rojananuangnit, Kulawan ; Arayangkoon, Eakkachai ; Pengrungreungwong, Sureeporn ; Preawsampran, Nontakorn ; Soomsawasdi, Piriya ; Chantiwas, Ratchada ; Tinpowong, Natnaree ; Samakhararaksakul, Rujira ; Katkingkaew, Kanokwan

INTRODUCTION:

Intravitreal injections of anti-vascular endothelial growth factor (anti-VEGF) agents are a primary management option for retinal diseases. Acute elevation of intraocular pressure (IOP) is a complication associated with these injections that should be considered. This study investigated and compared the prophylactic effects of fixed combination anti-glaucoma medication on IOP spikes following intravitreal anti-VEGF injections.

METHODS:

This randomized double-blind clinical trial included one eye of each participant indicated for treatment with intravitreal injection of anti-VEGF agents (bevacizumab, aflibercept, and ranibizumab) and randomly allocated to one of the three prophylactic anti-glaucoma medications, with each drug further divided into one- and two-drop regimens before intravitreal injection. Participants with allergies or contraindications to medications were excluded from the pretreatment groups and were invited to participate in the control group.

RESULTS:

The study involved 308 participants: 89 in the dorzolamide/timolol group, 86 in the brimonidine/timolol group, 101 in the brinzolamide/brimonidine group, and 32 in the control group. Baseline characteristics and IOP were comparable across all groups. In the prophylactic premedication groups, mean IOP at 30 min were within 21 mmHg and returned to their baseline at 1 h. Mean IOP measurements between baseline and 30 min in the brimonidine/timolol two-drop regimen were not significantly different: 13.72 ± 4.63 vs 15.11 ± 4.39 mmHg, p = 0.096. In the control group, IOP significantly increased from baseline at 30 min and 1 h post-injection: 14.31 ± 4.10, 22.15 ± 8.64, and 18.36 ± 7.52 mmHg, respectively, p < 0.001.

CONCLUSION:

Topical fixed combination anti-glaucoma medication used as a prophylactic treatment before intravitreal anti-VEGF injections significantly prevented IOP spikes post-injection, with a comparable effect among three medications. Prophylactic treatment of IOP spikes should be considered as standard care to prevent further damage in patients with compromised retinal vascular and optic nerve perfusion.

TRIAL REGISTRATION:

TCTR20241005001, retrospectively registered.

2025-01-14·JOURNAL OF CHROMATOGRAPHIC SCIENCE

A Simple Validated LC-UV Method for the Simultaneous Determination of Brimonidine and Brinzolamide in the Presence of Brinzolamide’s Degradation Product (Major Metabolite) in Rabbit Aqueous Humor

Article

作者: Wahab Mubarak, Marwa A ; Abo-Talib, Nisreen F ; El-Bagary, Ramzia I ; Elkady, Ehab ; Mohammad, M Abdul-Azim

Abstract:

A sensitive, specific, reliable and low-cost LC-UV method has been developed and validated for simultaneous quantification of brimonidine tartrate (BM) and brinzolamide (BZ) in rabbit aqueous humor (AH) in the presence of N-desethyl-brinzolamide (NDBZ); BZ is a major degradation product, and it is also considered to be its major metabolite. Dorzolamide hydrochloride (DZ) was used as an internal standard (IS). The analytes were extracted from rabbit AH samples by a simple pre-treatment utilizing ZnSO4.7H2O as a deproteinizing agent. The analytes were separated on a cyanopropyl Waters column (4.6 × 200 mm, 5 μm) with an isocratic mobile phase consisting of 25 mM ammonium acetate pH 4.5 (adjusted with 85% phosphoric acid):methanol:acetonitrile (94:4.5:1.5, v/v) at a flow rate of 1.0 mL min−1. The detection was done at 254 nm. The lower limit of quantification in rabbit AH was 100.0 ng mL−1. The method was validated according to EMA guidelines. The method was confirmed to be accurate, precise and linear over a range of 100.0–1000.0 ng mL−1 for BM and BZ. The method developed herein is simple, safe, eco-friendly, rapid and accurately applied for the quantification of BM and BZ, along with the successful separation of NDBZ, which is considered as a potential irritant degradation product of BZ.

2025-01-01·The Journal of clinical and aesthetic dermatology

Topical Brimonidine Tartrate 0.33% Gel versus 577-nm Pro-yellow Laser for the Treatment of Post-acne Erythema: A Comparative Study.

Article

作者: Fouda, Ibrahim ; Obaid, Zakaria Mahran ; Mohamed, Eman Awadallah

Background:

Post acne erythema (PAE) is a common sequela of inflammatory acne vulgaris resulting from the dilatation of microcapillaries within the papillary dermis, thinning of the epidermis, and release of inflammatory cytokines. OBJECTIVE: The authors sought to compare the safety and efficacy of topical Brimonidine tartrate 0.33% gel versus A 577-nm pro-yellow laser for treatment of post acne erythema.

Methods:

This was a comparative study, randomized clinical trials conducted on 60 adult patients with PAE. Patients were assigned into two groups: Group I included 30 patients who received brimonidine tartrate 0.33% gel once daily for three months, and Group II included 30 patients who received Pro-yellow laser with 577-nm therapy, for four sessions at three weeks intervals. Evaluation of erythema was done by Clinician's Erythema Assessment (CEA) and Patient's Self-Assessment (PSA) scales at baseline and at the end of the therapy. The dermoscopic images were analyzed for percent area of erythema and the optical density (OD) using ImageJ® freeware.

Results:

Twenty-two patients (73.3%) were females and eight patients (26.7%) were males in Group I. In Group II, 20 patients (66.7%) were females and 10 patients (33.3%) were males. The mean±SD age of the studied groups was 22.07 years ±2.64 ranging from 20 to 24 years in Group I versus 20.93 years ±2.88 ranging from 19 to 23 years in Group II. Clinical improvement is distributed as follows among Group I; 56.7 percent are excellent, 56.7 percent good, 26.7 percent poor, and 10 percent fair for Group II; 33.3 percent good, 6.7 percent poor, and 60 percent excellent. There was no statistically significant difference between studied groups as regard Clinician's Erythema Assessment (CEA), Patient's Self-Assessment (PSA) mean area percentage and the optical density (OD) before treatment, while a statistically significant difference between studied groups after treatment was observed (p<0.001).

Conclusion:

Topical brimonidine tartrate 0.33% gel and 577-nm pro yellow laser were effective and well tolerated therapeutic options for treatment of Post acne erythema (PAE), however the 577-nm Pro yellow laser was superior to brimonidine tartrate 0.33% gel.

117

项与酒石酸溴莫尼定相关的新闻（医药）

2025-01-19

·信狐药迅

恒瑞PCSK9抑制剂自研降脂新药瑞卡西单抗、石药降糖药普卢格列汀获批上市| 新获批(1.13-1.19）

每周药品注册获批数据，分门别类呈现，一目了然。(1.13-1.19）新药上市申请药品名称企业注册分类受理号普卢格列汀片石药集团欧意药业有限公司1CXHS2300048赛沃替尼片和记黄埔医药(上海)有限公司2.4CXHS2400022赛沃替尼片和记黄埔医药(上海)有限公司2.4CXHS2400021注射用瑞卡西单抗广东恒瑞医药有限公司1CXSS2300046 新药临床申请药品名称企业注册分类受理号SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401166SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401165SYHA1813口服溶液上海润石医药科技有限公司1CXHL2401164CVI-2742胶囊西威埃医药技术(上海)有限公司1CXHL2401191CVI-2742胶囊西威埃医药技术(上海)有限公司1CXHL2401190DF-003胶囊上海药苑生物科技有限公司1CXHL2401186DF-003胶囊上海药苑生物科技有限公司1CXHL2401185DF-003胶囊上海药苑生物科技有限公司1CXHL2401184QLS1304片齐鲁制药有限公司1CXHL2401194QLS1304片齐鲁制药有限公司1CXHL2401195QLS1304片齐鲁制药有限公司1CXHL2401196ASN-3186胶囊上海亚虹医药科技有限公司1CXHL2401204NSP-1047A片诺沃斯达药业(上海)有限公司1CXHL2401210NSP-1047A片诺沃斯达药业(上海)有限公司1CXHL2401209GH56胶囊勤浩医药(苏州)有限公司1CXHL2401208GH56胶囊勤浩医药(苏州)有限公司1CXHL2401207GH56胶囊勤浩医药(苏州)有限公司1CXHL2401206ASN-3186胶囊上海亚虹医药科技有限公司1CXHL2401205Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401221Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401220Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401219达希替尼片轩竹生物科技股份有限公司1CXHL2401216达希替尼片轩竹生物科技股份有限公司1CXHL2401215Sonrotoclax薄膜包衣片百济神州(苏州)生物科技有限公司1CXHL2401222PLB1004胶囊鞍石药业(宁波)有限责任公司1CXHL2401226PLB1004胶囊鞍石药业(宁波)有限责任公司1CXHL2401225ANS014004片北京鞍石生物科技股份有限公司1CXHL2401224ANS014004片北京鞍石生物科技股份有限公司1CXHL2401223AZD0022阿斯利康全球研发(中国)有限公司1CXHL2401229AZD0022阿斯利康全球研发(中国)有限公司1CXHL2401228ICP-248片北京诺诚健华医药科技有限公司1CXHL2401217盐酸(R)-氯胺酮注射液江苏豪森药业集团有限公司2.1;2.4CXHL2401161盐酸(R)-氯胺酮注射液江苏豪森药业集团有限公司2.1;2.4CXHL2401159HQ2216注射液百诚医药(珠海横琴)有限公司2.2CXHL2401154注射用艾博韦泰前沿生物药业(南京)股份有限公司2.4CXHL2401176甲磺酸伏美替尼片上海艾力斯医药科技股份有限公司2.4CXHL2401238RGL-2201注射液上海瑞宏迪医药有限公司1CXSL2400756GenSci120注射液长春金赛药业有限责任公司1CXSL2400763GenSci120注射液长春金赛药业有限责任公司1CXSL2400765IBI3014信达生物制药(苏州)有限公司1CXSL2400768注射用KY-0301科弈(浙江)药业科技有限公司1CXSL2400767 仿制药申请药品名称企业注册分类受理号羧甲司坦口服溶液海南斯达制药有限公司3CYHS2300946奥美拉唑碳酸氢钠干混悬剂湖北邦泽医药有限公司3CYHS2301623氨氯地平贝那普利胶囊河北龙海药业有限公司3CYHS2301852二羟丙茶碱注射液河北千康医药科技有限责任公司3CYHS2302021帕拉米韦注射液长春澜江医药科技有限公司3CYHS2302932盐酸右哌甲酯缓释胶囊河南中帅药业有限公司3CYHS2303628普瑞巴林口服溶液常州四药制药有限公司3CYHS2301334氨溴特罗口服溶液南京创迪生物技术有限公司3CYHS2302950吡拉西坦注射液西安达莫制药有限公司3CYHS2400403磷酸奥司他韦胶囊植恩生物技术股份有限公司4CYHS2400901磷酸奥司他韦胶囊福建省闽东力捷迅药业股份有限公司4CYHS2400923托吡酯片海南日中天制药有限公司4CYHS2301074注射用两性霉素B脂质体江西艾施特制药有限公司4CYHS2301518注射用替考拉宁重庆药友制药有限责任公司4CYHS2301539复方甘草酸苷片东阳祥昇医药科技有限公司4CYHS2301720甲磺酸仑伐替尼胶囊吉林敖东洮南药业股份有限公司4CYHS2301719甲磺酸仑伐替尼胶囊吉林敖东洮南药业股份有限公司4CYHS2301718地诺孕素片南通联亚药业股份有限公司4CYHS2301847硫酸特布他林雾化吸入用溶液浙江金华康恩贝生物制药有限公司4CYHS2301885钆喷酸葡胺注射液四川国瑞药业有限责任公司4CYHS2301898间苯三酚注射液江苏悦兴药业有限公司4CYHS2302047非那雄胺片乐泰药业有限公司4CYHS2302057非那雄胺片乐泰药业有限公司4CYHS2302056西格列汀二甲双胍片(II)江苏康缘药业股份有限公司4CYHS2302127乳果糖口服溶液安徽美来药业股份有限公司4CYHS2302196吸入用异丙托溴铵溶液浙江金华康恩贝生物制药有限公司4CYHS2302237盐酸莫西沙星片河北天成药业股份有限公司4CYHS2302521复方氨基酸注射液(18AA-IX)四川科伦药业股份有限公司4CYHS2302546马来酸阿伐曲泊帕片瑞阳制药股份有限公司4CYHS2302556盐酸氮斯汀滴眼液浙江视方极医药科技有限公司4CYHS2302677甲苯磺酸艾多沙班片齐鲁制药有限公司4CYHS2302693甲苯磺酸艾多沙班片齐鲁制药有限公司4CYHS2302692甲苯磺酸艾多沙班片齐鲁制药有限公司4CYHS2302691地夸磷索钠滴眼液山东诺明康药物研究院有限公司4CYHS2302729马来酸咪达唑仑片宜昌人福药业有限责任公司4CYHS2302782氯雷他定糖浆南通广承制药有限公司4CYHS2302830伊布替尼胶囊江西科睿药业有限公司4CYHS2302871玛巴洛沙韦片郑州泰丰制药有限公司4CYHS2302877马来酸阿伐曲泊帕片湖南明瑞制药股份有限公司4CYHS2302991甲钴胺注射液广州一品红制药有限公司4CYHS2303000达比加群酯胶囊浙江诺得药业有限公司4CYHS2303164达比加群酯胶囊浙江诺得药业有限公司4CYHS2303163达比加群酯胶囊浙江诺得药业有限公司4CYHS2303162苯磺酸氨氯地平片广州一品红制药有限公司4CYHS2303193苯磺酸氨氯地平片广州一品红制药有限公司4CYHS2303192盐酸氮斯汀滴眼液浙江视方极医药科技有限公司4CYHS2303213沙库巴曲缬沙坦钠片江苏德源药业股份有限公司4CYHS2303296注射用紫杉醇(白蛋白结合型)河北天成药业股份有限公司4CYHS2303294硫酸羟氯喹片福建广生堂药业股份有限公司4CYHS2303516酒石酸溴莫尼定滴眼液广东众生药业股份有限公司4CYHS2303512贝前列素钠片江西科睿药业有限公司4CYHS2303507尼可地尔片浙江赛默制药有限公司4CYHS2303503罗沙司他胶囊哈尔滨三联药业股份有限公司4CYHS2302026罗沙司他胶囊哈尔滨三联药业股份有限公司4CYHS2302025罗沙司他胶囊广州康臣药业有限公司4CYHS2302564罗沙司他胶囊北京福元医药股份有限公司4CYHS2302942罗沙司他胶囊北京福元医药股份有限公司4CYHS2302941富马酸福莫特罗吸入溶液长风药业股份有限公司4CYHS2302621富马酸福莫特罗吸入溶液南京力成药业有限公司4CYHS2303034盐酸伊托必利片裕松源药业有限公司4CYHS2404103氯沙坦钾氢氯噻嗪片裕松源药业有限公司4CYHS2404128奥美沙坦酯氨氯地平片裕松源药业有限公司4CYHS2404050吸入用布地奈德混悬液浙江高跖医药科技股份有限公司4CYHS2302457玻璃酸钠滴眼液辅必成(上海)医药科技有限公司4CYHS2400844艾考糊精腹膜透析液芜湖道润药业有限责任公司4CYHS2401530贝伐珠单抗注射液上海生物制品研究所有限责任公司3.3CXSS2300058重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液海正生物制药有限公司3.4CXSS2300056重组人II型肿瘤坏死因子受体-抗体融合蛋白注射液海正生物制药有限公司3.4CXSS2300055德谷胰岛素利拉鲁肽注射液正大天晴药业集团股份有限公司3.3CXSL2400772 进口申请药品名称企业注册分类受理号厄达替尼片Janssen Biotech, Inc.5.1JXHS2300124厄达替尼片Janssen Biotech, Inc.5.1JXHS2300123厄达替尼片Janssen Biotech, Inc.5.1JXHS2300125帕博利珠单抗注射液Merck Sharp & Dohme LLC3.1JXSS2400034艾沙妥昔单抗注射液Sanofi Winthrop Industrie3.1JXSS2300090艾沙妥昔单抗注射液Sanofi Winthrop Industrie3.1JXSS2300091奥拉帕利片Natco Pharma Limited5.2JYHS2300075奥拉帕利片Natco Pharma Limited5.2JYHS2300074MRG-001注射液MEDREGEN, LLC2.3;2.4JXHL2400259Vorasidenib片Institut de Recherches Internationales Servier2.4JXHL2400265Vorasidenib片Institut de Recherches Internationales Servier2.4JXHL240026613价肺炎球菌多糖结合疫苗Pfizer Europe MA EEIG3.1JXSL2400209Itepekimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400200注射用德曲妥珠单抗Daiichi Sankyo, Inc.2.2JXSL2400217 中药相关申请药品名称企业注册分类受理号苦丁茶总皂苷提取物华医神农(珠海)医药科技有限公司1.2CXZL2400069苦丁茶皂苷片华医神农(珠海)医药科技有限公司1.2CXZL2400068 注：橙色字体部分结论为不批准或收到通知件；

申请上市上市批准临床申请

2025-01-12

·医学新视点

疗效长达8小时！早上滴几下，提高近视力的效果几乎维持整个白天

▎药明康德内容团队编辑日前，Tenpoint Therapeutics公布其第二项3期关键试验BRIO-II的积极顶线结果。分析显示，该试验达到了与美国FDA、欧洲药品管理局（EMA）和英国药品和健康产品管理局（MHRA）商定的预设主要终点，其所开发的Brimochol PF滴眼液相较于对照组可显著改善患者的近视力，维持时间最长达8小时。这表示患者只要在早上滴几滴眼药水，几乎整个白天的近视力都得到提高！此积极结果支持该公司预定在2025年上半年递交该疗法的上市申请。 BRIO-II是一项包含3个队列、多中心、随机、双盲的安全性和疗效研究，评估Brimochol PF滴眼液与卡巴胆碱单药滴眼液和安慰剂滴眼液相比，在视力正常（无近视眼或远视眼）的老花眼患者中的疗效与安全性，该研究共招募了629名受试者。分析显示，相较于对照组，Brimochol PF在所有时间点（最长至8小时）显著改善患者的近视力（p<0.008）。Brimochol PF还在所有时间点显示出临床和统计学显著的瞳孔缩小效果。瞳孔缩小是缩瞳药物类别疗法的关键作用机制，通过形成针孔效应，矫正近视力丧失并增加景深。Brimochol PF在实现这一效果的同时，还改善了远距离视力，并在10小时内逐渐消除了瞳孔缩小。随着白天后期瞳孔缩小的减少，可能降低夜间视力困难的风险。在为期12个月的在家用药阶段中，研究未观察到对视力或瞳孔作用的快速耐药现象。图片来源：123RF Brimochol PF在为期12个月的每日用药期间耐受性良好，无治疗相关的严重不良事件。额外分析显示，Brimochol PF显著改善了患者的阅读速度和基于NEI屈光误差生活质量问卷的患者报告的生活质量结果。 Brimochol PF结合了卡巴胆碱和溴莫尼定两种获批药物。缩瞳剂卡巴胆碱在缩小瞳孔的同时，可能刺激控制晶状体形状的睫状体肌肉的收缩，改变晶状体的形状，导致它的屈光特征发生变化和引起远视力下降。经常接受治疗的患者还会出现头痛、近视移位、眼睛发红等副作用。溴莫尼定是一种α2受体激动剂，它可以起到抑制睫状体肌肉收缩和减少红眼的作用，还可以提高卡巴胆碱的半衰期，让它的效果可以持续8-12个小时，这意味着早上滴一次眼药水可能管用一整天。推荐阅读全球数亿患者！中山眼科中心研究：“笑一笑”就能改善干眼，不亚于人工泪液造福中国3亿干眼患者，比滴眼液更方便！北京同仁医院接英团队：创新鼻喷剂安全有效 NEJM：挽救致盲病患者视力！基因编辑疗法治疗眼病，再获突破性进展参考资料： [1] Tenpoint Therapeutics Announces Positive Topline Data from Phase 3 Pivotal Study, BRIO-II, of BRIMOCHOL™ PF for the Treatment of Presbyopia. Retrieved January 9, 2025 from https://www.businesswire.com/news/home/20250109824922/en 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，传递医学新知

临床结果临床3期基因疗法

2025-01-10

·药明康德

疗效长达8小时！老花眼眼药水上市申请递交在即

▎药明康德内容团队编辑今日，Tenpoint Therapeutics公布其第二项3期关键试验BRIO-II的积极顶线结果。分析显示，该试验达到了与美国FDA、欧洲药品管理局（EMA）和英国药品和健康产品管理局（MHRA）商定的预设主要终点，其所开发的Brimochol PF滴眼液相较于对照组可显著改善患者的近视力，维持时间最长达8小时。这表示患者只要在早上滴几滴眼药水，几乎整个白天的近视力都得到提高！此积极结果支持该公司预定在2025年上半年递交该疗法的上市申请。 BRIO-II是一项包含3个队列、多中心、随机、双盲的安全性和疗效研究，评估Brimochol PF滴眼液与卡巴胆碱单药滴眼液和安慰剂滴眼液相比，在视力正常（无近视眼或远视眼）的老花眼患者中的疗效与安全性，该研究共招募了629名受试者。分析显示，相较于对照组，Brimochol PF在所有时间点（最长至8小时）显著改善患者的近视力（p<0.008）。Brimochol PF还在所有时间点显示出临床和统计学显著的瞳孔缩小效果。瞳孔缩小是缩瞳药物类别疗法的关键作用机制，通过形成针孔效应，矫正近视力丧失并增加景深。Brimochol PF在实现这一效果的同时，还改善了远距离视力，并在10小时内逐渐消除了瞳孔缩小。随着白天后期瞳孔缩小的减少，可能降低夜间视力困难的风险。在为期12个月的在家用药阶段中，研究未观察到对视力或瞳孔作用的快速耐药现象。图片来源：123RF Brimochol PF在为期12个月的每日用药期间耐受性良好，无治疗相关的严重不良事件。额外分析显示，Brimochol PF显著改善了患者的阅读速度和基于NEI屈光误差生活质量问卷的患者报告的生活质量结果。 Brimochol PF结合了卡巴胆碱和溴莫尼定两种获批药物。缩瞳剂卡巴胆碱在缩小瞳孔的同时，可能刺激控制晶状体形状的睫状体肌肉的收缩，改变晶状体的形状，导致它的屈光特征发生变化和引起远视力下降。经常接受治疗的患者还会出现头痛、近视移位、眼睛发红等副作用。溴莫尼定是一种α2受体激动剂，它可以起到抑制睫状体肌肉收缩和减少红眼的作用，还可以提高卡巴胆碱的半衰期，让它的效果可以持续8-12个小时，这意味着早上滴一次眼药水可能管用一整天。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放参考资料： [1] Tenpoint Therapeutics Announces Positive Topline Data from Phase 3 Pivotal Study, BRIO-II, of BRIMOCHOL™ PF for the Treatment of Presbyopia. Retrieved January 9, 2025 from https://www.businesswire.com/news/home/20250109824922/en 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床结果临床3期临床2期

100 项与酒石酸溴莫尼定相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02076	酒石酸溴莫尼定	S01EA05 D11AX21	DB00484

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
眼睛发红	美国	Bausch & Lomb, Inc.	2017-12-22
玫瑰痤疮	美国	Galderma Laboratories LP	2013-08-23
青光眼	日本	Senju Pharmaceutical Co., Ltd.	2012-01-18
低眼压	美国	AbbVie, Inc.	2005-08-19
开角型青光眼	美国	Allergan, Inc.	1996-09-06
高眼压症	美国	Allergan, Inc.	1996-09-06

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
季节性过敏性结膜炎	临床3期	美国	Bausch & Lomb, Inc.	2022-11-18
变应性结膜炎	临床3期	美国	Bausch & Lomb, Inc.	2022-10-12
红斑	临床3期	美国	Bausch & Lomb, Inc.	2013-11-07
充血	临床3期	美国	Bausch & Lomb, Inc.	2013-11-07
皮疹	临床2期	法国	Tarian Pharma	2025-01-20
毛囊炎	临床2期	法国	Tarian Pharma	2025-01-20
视网膜脱离	临床2期	美国	Allergan Ltd. (Ireland)	2009-11-01
视网膜脱离	临床2期	印度	Allergan Ltd. (Ireland)	2009-11-01
视网膜脱离	临床2期	以色列	Allergan Ltd. (Ireland)	2009-11-01
视网膜脱离	临床2期	菲律宾	Allergan Ltd. (Ireland)	2009-11-01

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临床结果

适应症

分期

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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


NCT05579730 (CTgov)	临床3期	变应性结膜炎	188	Brimonidine tartrate 0.025%/ketotifen fumarate 0.035% (Combination)	範遞製鏇獵簾鑰憲製觸(襯齋鏇艱衊憲鬱構網範) = 構餘選窪鬱選鑰構積網網襯膚膚鑰衊憲簾鬱遞 (鹽鹹簾糧艱範衊鏇鹽繭, 鏇醖鹹築淵鬱醖壓鬱構 ~ 襯廠夢網願獵積範鹹選) 更多	-	2025-02-14
				Ketotifen Fumarate 0.035% (Ketotifen Fumarate)	範遞製鏇獵簾鑰憲製觸(襯齋鏇艱衊憲鬱構網範) = 鑰積繭顧齋膚簾範壓蓋網襯膚膚鑰衊憲簾鬱遞 (鹽鹹簾糧艱範衊鏇鹽繭, 願選廠築憲齋範夢夢願 ~ 願襯蓋鏇醖壓膚簾齋鏇) 更多
NCT05360784 (CTgov)	临床3期	眼睛发红	380	Brimonidine tartrate ophthalmic solution 0.025% preservative-free formulation (Brimonidine Tartrate Preservation-free)	願艱餘繭廠窪鹹醖蓋齋(衊夢鹽範憲獵糧壓淵艱) = 糧膚鬱憲衊積範襯醖獵鬱積壓廠壓獵觸觸願築 (願選衊製膚夢構膚鏇餘, 積窪構積窪選遞襯窪鏇 ~ 網襯鏇艱遞鹹獵廠獵襯) 更多	-	2024-08-26
				Lumify® (brimonidine tartrate ophthalmic solution 0.025%) (Lumify®)	願艱餘繭廠窪鹹醖蓋齋(衊夢鹽範憲獵糧壓淵艱) = 積網襯壓餘鏇膚願淵鑰鬱積壓廠壓獵觸觸願築 (願選衊製膚夢構膚鏇餘, 醖鑰衊壓淵窪網鹹鹹壓 ~ 簾選窪積鬱製積艱糧壓) 更多
ARVO2023	N/A	青光眼	-	Liposomal formulation with brimonidine, ribitol, and taurine	糧鹽繭願壓築範壓鬱餘(醖鏇憲繭廠選淵鏇顧齋) = 醖積選憲鹹鬱餘鏇壓選淵齋築鑰繭衊壓獵夢顧 (鹹網餘繭淵網製夢淵衊 ) 更多	-	2023-04-23
				Liposomal formulation with brimonidine, ribitol, taurine, and HPMC	糧鹽繭願壓築範壓鬱餘(醖鏇憲繭廠選淵鏇顧齋) = 襯蓋繭艱夢淵醖憲顧膚淵齋築鑰繭衊壓獵夢顧 (鹹網餘繭淵網製夢淵衊 ) 更多
NCT03418727 (CTgov)	临床2期	干眼综合征	84	Corticosteroid+Brimonidine (Brimonidine and Corticosteroid Combination Therapy)	築製齋觸構鏇選夢觸構(選窪衊鏇鬱網窪衊範鬱) = 獵餘鹽觸鑰壓蓋憲鏇鑰淵顧鏇齋鏇獵簾構醖鏇 (製顧淵膚夢築築遞願簾, 築鹽顧顧醖醖觸艱鏇獵 ~ 餘構鏇鬱願壓醖廠願觸) 更多	-	2022-07-06
				Brimonidine (Brimonidine Monotherapy)	築製齋觸構鏇選夢觸構(選窪衊鏇鬱網窪衊範鬱) = 艱夢鹽膚網鑰憲淵衊願淵顧鏇齋鏇獵簾構醖鏇 (製顧淵膚夢築築遞願簾, 糧夢繭網範艱遞夢網糧 ~ 網餘衊蓋鑰醖鬱鬱顧積) 更多
NCT03785340 (CTgov)	临床3期	干眼症	252	Brimonidine Tartrate	簾遞艱廠夢鹹鏇淵簾憲(膚齋窪鏇廠鏇壓齋獵衊) = 膚夢積窪艱蓋壓選繭壓餘衊醖醖蓋餘繭繭製獵 (壓獵壓築製遞醖遞鹽遞, 觸淵鑰鹽鬱鹽簾製襯觸 ~ 衊網選製衊壓顧襯築憲) 更多	-	2022-06-06
NCT03760185 (CTgov)	临床2期	术中软盘虹膜综合征（IFIS）	13	Brimonidine Tartrate (Brimonidine Tartrate 0.2%)	簾繭襯鹽遞繭艱餘齋繭(醖蓋醖鹽窪獵鑰選憲餘) = 衊顧獵壓築積艱窪餘艱夢範鹽鹹醖齋鹹膚糧淵 (膚簾網蓋艱簾齋獵糧壓, 範醖醖構淵遞網鹹膚遞 ~ 鑰範夢範製鏇鑰蓋鹹鹽) 更多	-	2022-04-20
				Brimonidine Tartrate (Control - Untreated)	簾繭襯鹽遞繭艱餘齋繭(醖蓋醖鹽窪獵鑰選憲餘) = 範積範網簾選蓋蓋淵窪夢範鹽鹹醖齋鹹膚糧淵 (膚簾網蓋艱簾齋獵糧壓, 膚憲範構積觸淵鹽淵鹹 ~ 鑰觸蓋壓鑰艱衊窪餘鹽) 更多
NCT03450629 (CTgov)	临床3期	开角型青光眼	682	Brimonidine Tartrate Ophthalmic Suspension (PDP-716)	窪廠糧糧選築齋蓋選憲(艱廠憲鑰鏇顧廠積網積) = 醖遞獵遞醖選鏇繭願憲構淵願構積憲獵遞艱鹽 (遞廠糧憲製築製廠積遞, 鑰製觸齋製網遞鬱遞鑰 ~ 築選觸願壓廠遞選齋繭) 更多	-	2022-02-15
				Brimonidine Tartrate Ophthalmic Solution (Brimonidine Tartrate Ophthalmic Solution)	窪廠糧糧選築齋蓋選憲(艱廠憲鑰鏇顧廠積網積) = 憲積糧製範憲齋憲積製構淵願構積憲獵遞艱鹽 (遞廠糧憲製築製廠積遞, 壓夢積選壓餘壓簾膚窪 ~ 簾艱構窪積膚觸淵繭艱) 更多
AAI2021	N/A	肥大细胞增多症	-	Vancomycin	衊鬱襯膚鹽衊壓膚壓廠(憲遞壓範鑰糧衊憲遞願) = The use of VCM is associated with several potential adverse reactions 醖繭齋淵衊觸壓壓艱遞 (願廠衊壓獵鹽鹽鏇築醖 ) 更多	-	2021-05-01
NCT03323164 (CTgov)	临床4期	开角型青光眼 \| 低眼压性青光眼	35	Brimonidine Tartrate (Brimonidine)	鏇鏇襯鑰鹽艱鹹築襯窪(膚鹽憲齋觸餘簾齋願憲) = 憲餘齋遞憲鬱範糧選餘範餘醖艱鏇窪網築糧壓 (餘鹹憲網淵網淵繭壓範, 觸築簾艱獵簾構淵憲鬱 ~ 觸淵構衊齋鑰醖構願憲) 更多	-	2020-12-31
				Timolol Maleate (Timolol)	鏇鏇襯鑰鹽艱鹹築襯窪(膚鹽憲齋觸餘簾齋願憲) = 鹹窪襯範壓範繭餘齋遞範餘醖艱鏇窪網築糧壓 (餘鹹憲網淵網淵繭壓範, 廠憲糧顧廠壓積醖窪鏇 ~ 遞鏇積鏇廠簾積餘鬱蓋) 更多
NCT02385240 (CTgov)	临床3期	玫瑰痤疮	552	Brimonidine Topical Gel, 0.33 percent (Perrigo) (Test Product)	鏇衊蓋選醖繭顧鏇膚艱(鏇遞積憲網衊積衊鑰顧) = 鏇夢願鏇積獵齋鏇衊廠膚艱願繭廠鬱鬱遞繭築 (窪憲鬱鹹獵糧繭襯淵窪, 鏇鹹淵簾繭蓋積構繭製 ~ 壓網鑰顧獵窪簾遞齋夢) 更多	-	2020-12-14
				Brimonidine Topical Gel, 0.33 percent (Reference) (Reference Product)	鏇衊蓋選醖繭顧鏇膚艱(鏇遞積憲網衊積衊鑰顧) = 顧糧齋積範壓衊選齋襯膚艱願繭廠鬱鬱遞繭築 (窪憲鬱鹹獵糧繭襯淵窪, 獵構願齋夢鹹糧選夢糧 ~ 顧顧鬱選淵窪遞鑰鹽鏇) 更多