A randomized, multi-site, parallel-group, prospective study of patients who are adults with a diagnosis of mild to moderate open-angle glaucoma (OAG), currently on an on-label use of combination topical medication of Cosopt and Latanoprost for a minimum of 1 month.

开始日期2025-05-14

申办/合作机构

Prairie Eye Center Ltd.

NCT04944290

/ Completed临床3期

Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide/Brimonidine Ophthalmic Suspension 1% to Simbrinza® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes

To compare the efficacy and safety of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.

开始日期2021-05-28

申办/合作机构

Padagis US LLC

TCTR20241005001

/ Completed临床3期IIT

The difference of IOP post intra vitreous injection among preoperative COSOPT, Combigan and Simbrinza instillation

开始日期2020-12-01

申办/合作机构-

100 项与布林佐胺溴莫尼定相关的临床结果

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100 项与布林佐胺溴莫尼定相关的转化医学

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100 项与布林佐胺溴莫尼定相关的专利（医药）

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项与布林佐胺溴莫尼定相关的文献（医药）

2021-04-01·Contact dermatitis2区 · 医学

Periocular allergic contact dermatitis caused by brinzolamide

2区 · 医学

Article

作者: Navarro‐Triviño, Francisco J. ; Ruiz‐Villaverde, Ricardo

A 52-yr-old woman was referred to our Contact Eczema Department with right-sided, chronic, periocular eczema that had developed over the past 12 mo.Ocular contact dermatitis caused by brinzolamide was diagnosed.ACD can involve the eyelids and/or conjunctiva, associated, or not, with chronic conjunctivitis or keratoconjunctivitis.Patch testing is the standard method for diagnosis of periocular ACD.It is recommended to test the ophthalmic medication (active ingredient) in addition to the excipients (mainly the preservatives).

2020-12-11·ACS pharmacology & translational science

Discovery to Launch of Anti-allergy (Emadine; Patanol/Pataday/Pazeo) and Anti-glaucoma (Travatan; Simbrinza) Ocular Drugs, and Generation of Novel Pharmacological Tools Such as AL-8810

Article

作者: Sharif, Najam A.

The eye and eyesight are exquistly designed and are precious, and yet we often take them for granted. Good vision is critical for our long-term survival and for humanity's enduring progress. Unfortunately, since ocular diseases do not culminate in life-and-death scenarios, awareness of the plight of millions of people suffering from such eye ailments is not publicized as other diseases. However, losing eyesight or falling victim to visual impairment is a frightening outlook for most people. Glaucoma, a collection of chronic optic neuropathies, of which the most prevalent form, primary open-angle glaucoma (POAG), is the second leading cause of irreversible blindness. POAG currently afflicts >70 million people worldwide and is an insidious, progressive, silent thief of sight that is asymptomatic. On the other hand, allergic conjunctivitis (AC), and the associated rhinitis ("hay-fever"), frequently victimizes a huge number of people worldwide, especially during seasonal changes. While not life-threatening, sufferers of AC soon learn the value of drugs to treat their signs and symptoms of AC as they desire rapid relief to overcome the ocular itching/pain, redness, and tearing AC causes. Herein, I will describe the collective efforts of many researchers whose industrious, diligent, and dedicated team work resulted in the discovery, biochemical/pharmacological characterization, development and eventual launch of drugs to treat AC (e.g., olopatadine [Patanol/Pataday/Pazeo] and emedastine [Emedine]), and for treating ocular hypertension and POAG (e.g., travoprost [Travatan ] and Simbrinza). This represents a personal perspective.

2018-12-01·Ophthalmology and therapy3区 · 医学

Brinzolamide/Brimonidine Fixed Combination: Simplifying Glaucoma Treatment Regimens

3区 · 医学

ArticleOA

作者: Moosavi, Reza ; Ansari, Ejaz

INTRODUCTION:

To simplify the medical treatment of glaucoma for patients on multiple drops by introducing brinzolamide/brimonidine tartrate fixed combination (BBFC) ophthalmic suspension 1%/0.2% (SIMBRINZA^®; Alcon Laboratories, Inc., Fort Worth, TX, USA) to the drop regimen and to establish its efficacy. To demonstrate that fixed combination (FC) therapies are associated with improvements in treatment adherence and persistence with reduced exposure to preservative-related ocular surface problems.

METHODS:

Retrospective study: 76 patients were identified as taking BBFC following a switch in treatment regimen. Intraocular pressure (IOP) prior to and 2-17.5 months (average 5.4 months) after the introduction of BBFC was measured. The change in the average number of bottles used per eye was recorded. The rate of adverse effects (AEs) of BBFC was recorded. A two-tailed paired sample t test was used to compare IOP prior to and after the introduction of BBFC for each eye.

RESULTS:

Mean change in IOP after BBFC introduction BBFC: - 2.76 mmHg (p < 0.0001). BBFC intolerance: 13%. On average there was a 0.24 reduction in the number of bottles of IOP-lowering medication used per eye (p < 0.0064).

CONCLUSION:

A switch to BBFC in the drop regimen is associated with a significant drop in IOP with reduced drop burden. Instead of a third IOP-lowering medication and bottle, a practitioner should consider using BBFC + prostaglandin analogue/FC drop for effective IOP control, reduced drop burden, reduced preservative load and increased likelihood of adherence. This study promotes the concept that any treatment should principally be assessed from the patients' perspective and quality of life.

项与布林佐胺溴莫尼定相关的新闻（医药）

2024-10-29

·药研

CDE老师文章｜混悬型滴眼剂仿制药药学研究的相关考虑

（点击图片查看详情）摘要:混悬型滴眼剂系指难溶性固体药物以微粒状态分散于介质中形成的无菌眼用液体制剂。本文从化学药品仿制药混悬型滴眼剂的处方、生产工艺、质量研究、包材和稳定性研究等药学方面问题进行了初步的探讨,汇总了国内外文献中混悬型滴眼剂开发过程中关键研究指标,以助于业界对混悬型滴眼剂仿制药的开发。眼用制剂系指直接用于眼部发挥治疗作用的无菌制剂,其中滴眼剂系指由原料药物与适宜辅料制成的供滴入眼内的无菌液体制剂,可分为溶液、混悬液或乳状液。混悬型滴眼剂系指难溶性固体药物以微粒状态分散于分散介质中形成的无菌眼用液体制剂。混悬型滴眼剂中活性成分以微粒状态分散于分散介质中,相比溶液型滴眼液,药物颗粒可在角膜前囊滞留,增加了与角膜的接触时间,有利于提高生物利用度[１] 。目前国内外已上市多种混悬型滴眼剂,如氯替泼诺混悬滴眼液、妥布霉素地塞米松混悬滴眼液、妥布霉素氯替泼诺滴眼液、布林佐胺溴莫尼定滴眼液、夫西地酸滴眼液、盐酸贝西沙星滴眼液等。 2023年2月,国家药品监督管理局药品审评中心(ＣＤＥ)发布了«化学药品仿制药溶液型滴眼剂药学研究技术指导原则»[２] ,阐述了溶液型滴眼剂药学研究的要求。对于混悬型滴眼剂,原料药不是以真溶液状态溶解于分散介质中,相较于溶液型滴眼剂药学研究要求,混悬型滴眼剂在处方、生产工艺、质量研究、包材和稳定性研究等方面有其特殊性。本文参考国内外药典、指导原则,并结合美国食品药品监督管理局(ＦＤＡ)各混悬型滴眼剂个例指导原则等,对化学药品仿制药混悬型滴眼剂药学研究中应关注的内容进行了探讨。１处方对于溶液型滴眼剂,ＣＤＥ发布的«化学药品仿制药溶液型滴眼剂药学研究技术指导原则»中,建议仿制药处方中辅料种类(Ｑ１)和用量(Ｑ２)应与参比制剂一致,其中辅料的用量相同是指仿制药辅料用量是参比制剂相应辅料用量的９５％ ~１０５％。对于与参比制剂中渗透压调节剂用量、缓冲剂用量和ｐＨ调节剂不同的处方,需标注不同之处,阐述选择的理由,并研究证明上述不同不影响产品的质量属性(如渗透压摩尔浓度、缓冲容量、ｐＨ值等物理化学特性)、安全性和有效性。对于混悬型滴眼剂,与溶液型滴眼剂一致,ＦＤＡ各混悬型滴眼剂个例指导原则[３－９] 中,建议仿制药处方中辅料种类(Ｑ１)和用量(Ｑ２)一致,辅料的用量相同是指仿制药辅料用量是参比制剂相应辅料用量的９５％~１０５％。通常,已上市的国内外混悬型滴眼剂说明书中公开了辅料的种类。参考ＦＤＡ公布的说明书,表１中列举了部分混悬型滴眼剂中处方组成。从ＦＤＡ公布的已上市混悬型滴眼剂处方来看,混悬型滴眼剂中辅料通常包括润湿剂、助悬剂、渗透压调节剂、ｐＨ调节剂、抑菌剂等。在混悬型滴眼剂仿制药的处方开发过程中,应基于参比制剂公开的说明书等信息,确定原料药及辅料的种类,同时应关注辅料的型号,尤其是助悬剂等关键辅料的型号,不同型号的辅料对混悬型滴眼剂质量可能有较大影响。如氯替泼诺混悬滴眼剂采用聚维酮作为助悬剂,而市售聚维酮存在多种型号,一般情况下应采用与参比制剂相同型号的辅料。在对混悬型滴眼剂处方筛选过程中,通常以渗透压摩尔浓度、粒度等作为考察指标,通过合适的理化手段,对辅料的用量进行筛选和解析,以达到辅料的种类和用量与参比制剂一致。多剂量滴眼剂一般应加适当的抑菌剂。对于处方中抑菌剂的用量,在参考参比制剂用量基础上,参照«中国药典»２０２０年版(四部)通则１１２１“抑菌效力检查法”,对拟定处方的抑菌效力进行考察,以确保抑菌效力符合药典抑菌效力检查法的规定,并在产品整个生命周期符合质量要求。２生产工艺滴眼剂为无菌制剂,因此滴眼剂的生产也应采用无菌/ 灭菌工艺。不同于溶液型滴眼剂,混悬型滴眼剂的原料药混悬于溶液中,通常无法通过０.２２μｍ的滤膜进行过滤除菌。目前,混悬型滴眼剂通常有无菌生产和灭菌生产两种不同的生产方式: ①无菌生产:由于原料药无法通过滤膜进行过滤除菌,在生产中通常将辅料溶于注射用水,过滤后制备得到辅料溶液,然后将提前处理的无菌原料药加入辅料溶液中,搅拌混合均质后,无菌条件下灌装得到成品。 ②灭菌生产:灭菌生产通常包括两种不同的生产方式,即浓溶液灭菌方式和稀配后灭菌方式,两种方式的不同在于灭菌原辅料种类和灭菌体积的不同。对于浓溶液灭菌方式,通常将原料药与部分辅料分散于部分注射用水中,进行灭菌,其他辅料和注射用水通过滤膜无菌过滤,然后将灭菌后含有原料药的浓溶液与无菌过滤后的部分辅料溶液混合,均质后,无菌条件下灌装得到成品。对于稀配后灭菌方式,通常根据原辅料性质,按照一定顺序,配制得到最终稀溶液,灭菌后灌装得到成品。基于以上混悬型滴眼剂的生产工艺,在产品的工艺开发阶段,应重点对原料药的前处理、原辅料加入顺序及方式、无菌过滤参数或灭菌工艺参数等进行考察和研究。对于原料药的前处理,原料药的粒度是混悬型滴眼剂的关键质量属性,应对原料药的粒度分布进行考察和控制,可采用激光衍射仪等对原料药的ｄ(０.１)、ｄ(０.５)和ｄ(０.９)等进行测定和相应的控制。如采用微粉化方式对原料药进行前处理,应关注微粉化后原料药的晶型变化。对于无菌原料药,可选择采用无菌生产的原料药或采用辐照等方式对原料药进行灭菌处理。对于混悬型滴眼剂的工艺验证,除连续３批产品的工艺验证外,一般还包括除菌过滤验证,可参考国家药品监督管理局发布的«除菌过滤技术及应用指南»[１８－１９] 进行研究和验证。对于生产中所用的除菌滤芯,建议单次使用。另外,在生产工艺开发中,通常应对药液与生产组件的相容性进行研究[２０] ,以确认生产组件适用于产品的生产。３　原料药和辅料原料药应结合拟定的制剂生产工艺对其质量进行控制,如粒度分布、晶型、无菌、微生物限度等。对于辅料,除进行常规质量控制外,通常应对微生物限度进行控制。４　质量研究通常滴眼剂的质量属性包括性状、鉴别、溶液澄清度与颜色、渗透压摩尔浓度、ｐＨ值、黏度(如适用)、相对密度、可见异物、有关物质、元素杂质、无菌、抑菌剂含量、抗氧剂含量、含量测定、装量/ 装量差异等。对于混悬型滴眼剂,还应关注原料药粒度和粒度分布、体外释放、滴出量、表面张力、沉降体积比、再混悬/ 再分散性、可溶性的药物量、含量均匀度等。部分研究项目讨论如下: ①原料药粒度和粒度分布:原料药粒度和粒度分布是混悬型滴眼剂中关键质量属性,混悬型滴眼剂质量研究通常应包含粒度和粒度分布的研究。氯替泼诺混悬滴眼液(规格:０.５％和０.２％)等ＦＤＡ个例指导原则中建议采用３批自制样品与３批参比制剂进行粒度与粒度分布对比,样品的制备方法和粒度测定方法应进行验证以确保方法的准确性和可靠性,同时在方法开发过程中应考察在不同稀释条件下对原料药粒度和粒度分布测定结果的影响,测定参数为ｄ(０.５)和ＳＰＡＮ[ｄ(０.９)－ｄ(０.１) / ｄ(０.５)],采用群体生物等效性(ＰＢＥ)研究的分析方法进行ｄ(０.５)和ＳＰＡＮ数据对比,基于９５％置信区间上限判定自制品与参比制剂的生物等效性。 ②体外释放:混悬型滴眼剂中原料药的体外释放可反映处方和工艺变化,并可能影响药物的吸收程度。一般情况下,体外释放方法应尽可能模拟实际临床的使用场景,并兼顾平台期,体外释放方法开发应包括释放介质种类和体积、取样时间点、温度的选择等。氯替泼诺混悬滴眼液( 规格: ０. ５％和０.２％)等ＦＤＡ个例指导原则中建议采用３批自制样品与３批参比制剂进行体外释放(ＩＶＲＴ)对比,同时采用恰当的统计方法(如非模型依赖相似因子比较法,ｆ２)对体外释放数据进行比较分析。 ③滴出量:人的眼睛对于滴眼液的容量有限,过高的滴出量会造成药物的浪费,过低的滴出量可能影响药物的疗效。ＦＤＡ«局部用滴眼剂的质量考虑»草案[２１] 中推荐仿制药每滴的滴出量应在参比制剂滴出量的±１０％范围内,且每滴的滴出量应为２０~７０ μＬ范围内。 ④可溶性的药物量:通常混悬型滴眼剂中可能会有微量或少量的原料药溶于溶液中,可溶性的药物量除可比较自制品与参比制剂质量外,还可反映药物处方、工艺设计的合理性。氯替泼诺混悬滴眼液(１％规格和０.２５％规格)等ＦＤＡ个例指导原则中建议对可溶性药物量进行对比研究。 ⑤再混悬/ 再分散性、含量均匀度:再混悬/ 再分散性是混悬型滴眼剂重要质量指标,在质量研究中,应结合参比制剂说明书使用方法,如使用前是否需摇匀等,对再混悬/ 再分散性等特性进行对比研究。同时ＦＤＡ«局部用滴眼剂的质量考虑»草案中建议对多剂量混悬型滴眼剂含量均匀度进行测定,通常应对滴眼剂瓶上部、中部和底部药物的含量进行测定,以确证原料药是否均一地分散且在整个有效期内可被均一地递送。５包材研究和稳定性研究混悬型滴眼剂仿制药,应根据参比制剂所用包材和产品特点选择合适的包装材料。原则上,所选择的内包材在对产品保护性、功能性方面,应不低于参比制剂所用包材。同时应考察产品与包材的相容性,并对包材的密封性进行研究。包材的密封性可参考«化学药品注射剂包装系统密封性研究技术指南(试行)»[２０] 开展研究。对于稳定性,应结合包材的特点(如半透性包材等)设计相关的稳定性试验,在稳定性考察期间,除一般质量研究项目外,还应对原料药粒度与粒度分布、沉降体积比、再混悬/ 再分散性、含量均匀度、抑菌剂含量、抗氧剂含量、失水率等进行考察,必要时应考虑对原料药体外释放进行考察。稳定性试验样品通常应包括直立放置和倒置(或平放)两种放置方式。对于混悬型滴眼剂,ＦＤＡ«局部用滴眼剂的质量考虑»草案中要求,应进行冷冻/ 解冻热循环研究,以评估运输和处理过程中可能遇到的任何高温和低温变化的影响,这些变化可能影响药品的质量。ＦＤＡ建议该研究由３个循环组成,温度在冷冻(－２０℃至０ ℃)和环境温度(２５ ℃至３５ ℃)之间循环,累计最少３ｄ。在整个研究过程中,以及在预定的周期数结束时,应对样品所有质量研究项目进行分析,并与参比制剂进行比较。对于多剂量滴眼剂,还应考察其使用中的稳定性。６小结混悬型滴眼剂作为较复杂的滴眼剂型,其仿制药的开发除遵循一般滴眼剂的开发路径外,还需关注其特殊性,如粒度和粒度分布、含量均匀性等。目前,国内外监管机构暂未发布专门的关于混悬型滴眼剂研究的指导原则,仿制药的开发存在一定的难度,国内上市的混悬型滴眼剂仿制药较少,本文对混悬型滴眼剂仿制药开发中相关的药学问题进行了探讨,以供业界参考。参考文献 [１]　易婷,赵雁,陶涛. 混悬型滴眼剂的研究进展[Ｊ]. 中国医药工业杂志,２０２０,５１(６):６７９－６８６. [２] 国家药品监督管理局药品审评中心.化学药品仿制药溶液型滴眼剂药学研究技术指导原则[ＥＢ/ ＯＬ].(２０２３－０２－１６)[２０２４－０５－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ｃｄｅ.ｏｒｇ.ｃｎ/ ｍａｉｎ/ ｎｅｗｓ/ｖｉｅｗＩｎｆｏＣｏｍｍｏｎ/４ａ３７３７０ｃ９２ｅ２７１１ｆａ８０ａ３６８９７００ｄ７９９１. [３] ＦＤＡ.ＤｒａｆｔＧｕｉｄａｎｃｅｏｎＬｏｔｅｐｒｅｄｎｏｌＥｔａｂｏｎａｔｅ[ＥＢ/ ＯＬ].(２０１９－０９)[２０２４－０５－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｐｓｇ/ ＰＳＧ＿２１０５６５.ｐｄｆ. [４] ＦＤＡ.ＤｒａｆｔＧｕｉｄａｎｃｅｏｎＬｏｔｅｐｒｅｄｎｏｌＥｔａｂｏｎａｔｅ[ＥＢ/ ＯＬ].(２０２４－０２)[２０２４－０５－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｐｓｇ/ ＰＳＧ＿０２０５８３.ｐｄｆ. [５] ＦＤＡ.ＤｒａｆｔＧｕｉｄａｎｃｅｏｎＬｏｔｅｐｒｅｄｎｏｌＥｔａｂｏｎａｔｅ[ＥＢ/ ＯＬ].(２０２２－０８)[２０２４－０５－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｐｓｇ/ ＰＳＧ＿２１０９３３.ｐｄｆ. [６] ＦＤＡ.ＤｒａｆｔＧｕｉｄａｎｃｅｏｎＬｏｔｅｐｒｅｄｎｏｌＥｔａｂｏｎａｔｅ[ＥＢ/ ＯＬ].(２０２４－０２)[２０２４－０５－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｐｓｇ/ ＰＳＧ＿０２０８０３.ｐｄｆ. [７] ＦＤＡ.ＤｒａｆｔＧｕｉｄａｎｃｅｏｎＬｏｔｅｐｒｅｄｎｏｌＥｔａｂｏｎａｔｅ;Ｔｏｂｒａｍｙｃｉｎ[ＥＢ/ ＯＬ]. ( ２０２４－０２) [ ２０２４－０５－１６]. ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｐｓｇ/ ＰＳＧ＿０５０８０４.ｐｄｆ. [８] ＦＤＡ.ＤｒａｆｔＧｕｉｄａｎｃｅｏｎＤｅｘａｍｅｔｈａｓｏｎｅ;Ｔｏｂｒａｍｙｃｉｎ[ＥＢ/ ＯＬ].(２０２４－０２)[２０２４－０５－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｐｓｇ/ ＰＳＧ＿０５０８１８.ｐｄｆ. [９] ＦＤＡ.ＤｒａｆｔＧｕｉｄａｎｃｅｏｎＢｅｓｉｆｌｏｘａｃｉｎｈｙｄｒｏｃｈｌｏｒｉｄｅ[ＥＢ/ ＯＬ].(２０２０－０２)[２０２４－０５－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｐｓｇ/ ＰＳＧ＿０５０８１８.ｐｄｆ. [１０] ＦＤＡ.ＬａｂｅｌｓｆｏｒＮＤＡ２１０５６５[ＥＢ/ ＯＬ].２０２０－０４) [２０２４－０５－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ａｃｃｅｓｓｄａｔａ.ｆｄａ.ｇｏｖ/ ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｌａｂｅｌ/２０２０/２１０５６５ｓ００３ｌｂｌ.ｐｄｆ. [１１] ＦＤＡ. ＬａｂｅｌｓｆｏｒＮＤＡ０２０５８３ [ ＥＢ/ ＯＬ]. ( １９９８－０３)[ ２０２４－０５－１６]. ｈｔｔｐｓ:/ / ｗｗｗ. ａｃｃｅｓｓｄａｔａ. ｆｄａ. ｇｏｖ/ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｌａｂｅｌ/１９９８/２０５８３ｌｂｌ.ｐｄｆ. [１２] ＦＤＡ. ＬａｂｅｌｓｆｏｒＮＤＡ２１０９３３ [ ＥＢ/ ＯＬ]. ( ２０２０－１０)[ ２０２４－０５－１６]. ｈｔｔｐｓ:/ / ｗｗｗ. ａｃｃｅｓｓｄａｔａ. ｆｄａ. ｇｏｖ/ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｌａｂｅｌ/２０２０/２１０９３３ｓ０００ｌｂｌ.ｐｄｆ. [１３] ＦＤＡ. ＬａｂｅｌｓｆｏｒＮＤＡ０２０８０３ [ ＥＢ/ ＯＬ]. ( １９９８－０３)[ ２０２４－０５－１６]. ｈｔｔｐｓ:/ / ｗｗｗ. ａｃｃｅｓｓｄａｔａ. ｆｄａ. ｇｏｖ/ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｌａｂｅｌ/１９９８/２０８０３ｌｂｌ.ｐｄｆ. [１４] ＦＤＡ. ＬａｂｅｌｓｆｏｒＮＤＡ０５０８０４ [ ＥＢ/ ＯＬ]. ( ２０２１－１０)[ ２０２４－０５－１６]. ｈｔｔｐｓ:/ / ｗｗｗ. ａｃｃｅｓｓｄａｔａ. ｆｄａ. ｇｏｖ/ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｌａｂｅｌ/２０２１/０５０８０４ｓ０２６ｌｂｌ.ｐｄｆ. [１５] ＦＤＡ. ＬａｂｅｌｓｆｏｒＮＤＡ０５０８１８ [ ＥＢ/ ＯＬ]. ( ２０２２－０８)[ ２０２４－０５－１６]. ｈｔｔｐｓ:/ / ｗｗｗ. ａｃｃｅｓｓｄａｔａ. ｆｄａ. ｇｏｖ/ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｌａｂｅｌ/２０２２/０５０８１８ｓ００７ｓ００８ｓ０0９ｌｂｌ.ｐｄｆ. [１６] ＦＤＡ. ＬａｂｅｌｓｆｏｒＮＤＡ０２２３０８ [ ＥＢ/ ＯＬ]. ( ２０１８－０３)[ ２０２４－０５－１６]. ｈｔｔｐｓ:/ / ｗｗｗ. ａｃｃｅｓｓｄａｔａ. ｆｄａ. ｇｏｖ/ｄｒｕｇｓａｔｆｄａ＿ｄｏｃｓ/ ｌａｂｅｌ/２０１８/０２２３０８ｓ０１３ｌｂｌ.ｐｄｆ. [１７] ＦＤＡ.ＱｕａｌｉｔｙＣｏｎｓｉｄｅｒａｔｉｏｎｓｆｏｒＴｏｐｉｃａｌＯｐｈｔｈａｌｍｉｃＤｒｕｇＰｒｏｄｕｃｔｓ[ＥＢ/ ＯＬ].(２０２３－１２) [２０２４－０５－１６].ｈｔｔｐｓ:/ /ｗｗｗ. ｆｄａ. ｇｏｖ/ ｒｅｇｕｌａｔｏｒｙ－ｉｎｆｏｒｍａｔｉｏｎ/ ｓｅａｒｃｈ－ｆｄａ－ｇｕｉｄａｎｃｅ－ｄｏｃｕｍｅｎｔｓ/ ｑｕａｌｉｔｙ－ｃｏｎｓｉｄｅｒａｔｉｏｎｓ－ｔｏｐｉｃａｌ－ｏｐｈｔｈａｌｍｉｃ－ｄｒｕｇ－ｐｒｏｄｕｃｔｓ. [１８] 国家药品监督管理局.国家药品监督管理局关于发布除菌过滤技术及应用指南等３个指南的通告[ＥＢ/ ＯＬ].(２０１８－０７－３１)[２０２４－０６－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ｎｍｐａ.Ｇｏｖ.ｃｎ/ ｘｘｇｋ/ ｇｇｔｇ/ｙｐｇｇｔｇ/ ｙｐｑｔｇｇｔｇ/２０１８０９１１１７０３０１４３９.ｈｔｍｌ. [１９] 国家药品监督管理局.无菌工艺模拟试验指南( 无菌制剂) [ ＥＢ/ ＯＬ]. ( ２０１８－０７－３１) [ ２０２４－０６－１６].ｈｔｔｐｓ:/ / ｗｗｗ. ｎｍｐａ. ｇｏｖ. ｃｎ/ ｘｘｇｋ/ ｇｇｔｇ/ ｙｐｇｇｔｇ/ ｙｐｑｔｇｇｔｇ/２０１８０９１１１７０３０１４３９.ｈｔｍｌ. [２０] 国家药品监督管理局药品审评中心.国家药监局药审中心关于发布«化学药品注射剂包装系统密封性研究技术指南(试行)» 和«化学药品注射剂生产所用的塑料组件系统相容性研究技术指南( 试行)» 的通告[ＥＢ/ ＯＬ].( ２０２０－１０－２１) [ ２０２４－０６－１６]. ｈｔｔｐｓ:/ /ｗｗｗ. ｃｄｅ. ｏｒｇ. ｃｎ/ ｍａｉｎ/ ｎｅｗｓ/ ｖｉｅｗＩｎｆｏＣｏｍｍｏｎ/８ａ４ｆ９ｆ１６８４４ｆｂｅｄ６１７ｆ８ｅ８ｅｄ５９４８５ｃ１ｄ. [２１] ＦＤＡ. ＱｕａｌｉｔｙＣｏｎｓｉｄｅｒａｔｉｏｎｓｆｏｒＴｏｐｉｃａｌＯpｈｔｈａｌｍｉｃＤｒｕｇＰｒｏｄｕｃｔｓ. [ ＥＢ/ ＯＬ]. ( ２０２３－１２) [ ２０２４－０５－１６].ｈｔｔｐｓ:/ / ｗｗｗ.ｆｄａ.ｇｏｖ/ ｒｅｇｕｌａｔｏｒｙ－ｉｎｆｏｒｍａｔｉｏｎ/ ｓｅａｒｃｈ－ｆｄａ－ｇｕｉｄａｎｃｅ－ｄｏｃｕｍｅｎｔｓ/ ｑｕａｌｉｔｙ－ｃｏｎｓｉｄｅｒａｔｉｏｎｓ－ｔｏｐｉｃａｌｏｐｈｔｈａｌｍｉｃ－ｄｒｕｇ－ｐｒｏｄｕｃｔｓ. (收稿日期:２０２４－０５－２３) ------------THE END------------ 内容来源：药学研究 2024 Vol.43 点击查看：投稿获丰厚稿费（24年6月起执行）关注药研一路同行药研论坛：始终把为药品研发一线人员提供高质量、高性价比培训为第一宗旨。自2017年成立以来，累计举办100余期药品研发、注册领域研讨班。据统计，中国医药工业百强企业和研发百强企业均超过90%参加过药研收费类培训。截至2023年底，包括上海强生、辉瑞、阿斯利康、山德士、日本大冢、大鹏、卫材、小林制药、扬子江、恒瑞、正大天晴、东阳光、科伦、中科院等在内的2800余家企事业单位参加过药研线下收费培训，得到业界普遍认可与好评！药研学院：已同众多企业合作超百期直播课，全网观看突破100万+，药研直播课聚焦药品研发相关主题，平均观看人数行业领先。药研自媒体矩阵20万+：目前药研公众号研发领域关注用户约10万人！双直播平台10万人，微信社群5万人，其中制药企业和研发机构关注量5000+。商务合作：15911172616

2024-01-09

·BioSpace

Alcon Announces Positive Topline Results From Phase 3 COMET Trials of AR-15512, a Novel Topical Drug Candidate for Dry Eye

AR-15512, a topical transient receptor potential melastatin 8 (TRPM8) agonist, is a first-in-class product candidate for the treatment of the signs and symptoms of dry eye disease In both pivotal efficacy and safety studies (COMET-2 and COMET-3), the primary endpoint was achieved (p <0.0001) Dry eye affects an estimated 38 million people in the U.S. and less than 10% of diagnosed patients are treated with a prescription product1 GENEVA--(BUSINESS WIRE)-- Alcon (SIX/NYSE: ALC), the global leader in eye care dedicated to helping people see brilliantly, today announced positive topline results from the two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512, a candidate treatment for the signs and symptoms of dry eye disease (DED). In both COMET-2 and COMET-3, which enrolled more than 930 dry eye subjects in total (randomized 1:1 to AR-15512 or vehicle control), the primary endpoint of the proportion of subjects with at least a 10-mm increase in unanesthetized Schirmer’s score (a measure of tear production) achieved statistical significance at Day 14 [p<0.0001]. These data are consistent with the proposed mechanism of action of AR-15512. “We are excited by AR-15512 as it has the potential to address the limitations of current dry eye prescription options and provide Eye Care Professionals (ECPs) and dry eye sufferers with a new and effective approach to the management of dry eye, a chronic and undertreated disease,” said David Endicott, CEO of Alcon. “AR-15512 is the first product candidate in our emerging ophthalmic pharmaceutical portfolio, representing our legacy of commitment to innovation in eye care.” AR-15512 represents an opportunity to bring relief to dry eye sufferers. While DED is one of the most common ocular disorders, affecting an estimated 38 million people in the U.S., only about 18 million are diagnosed and less than 10% of those diagnosed are treated with a prescription product. This represents the significant need for an effective chronic treatment that can provide rapid natural tear production.1 In these studies, additional data derived from secondary endpoints demonstrated the rapid onset and sustained tear production associated with AR-15512 compared to vehicle, as early as Day 1 and persistent to Day 90. Overall, AR-15512 was well tolerated and no serious ocular adverse events were reported. “A key gap in dry eye medications is rapid speed of onset,” said Edward Holland, MD, Professor of Ophthalmology at the University of Cincinnati, a key advisor on COMET-2 and -3 and Senior Scientific Advisor at Alcon. “AR-15512 demonstrated this important achievement in both pivotal efficacy and safety studies and it represents a first-in-class candidate for chronic dry eye.” AR-15512 is an investigational drug product that has not been submitted to the U.S. Food and Drug Administration (FDA) for approval and is not currently commercially available. Alcon anticipates filing the NDA for AR-15512 with FDA in mid-2024. Alcon's ophthalmic pharmaceutical portfolio currently includes Rocklatan®, Rhopressa®, Simbrinza®, Eysuvis®, and Inveltys®. About Dry Eye Dry eye disease is one of the most common ocular surface disorders, affecting an estimated 38 million adults in the United States and an estimated 719 million more adults globally.1 While once considered a disease of aging populations, modern advancements, such as prolonged digital screen time, have contributed to a significant rise in DED across age and gender.2 Many existing prescription options for dry eye disease are generally regarded by many eye care professionals and patients as inadequate due to low treatment efficacy, slow onset of action and/or poor tolerability.3 About Alcon Alcon helps people see brilliantly. As the global leader in eye care with a heritage spanning over 75 years, we offer the broadest portfolio of products to enhance sight and improve people’s lives. Our Surgical and Vision Care products touch the lives of more than 260 million people in over 140 countries each year living with conditions like cataracts, glaucoma, retinal diseases and refractive errors. Our more than 25,000 associates are enhancing the quality of life through innovative products, partnerships with Eye Care Professionals and programs that advance access to quality eye care. Learn more at . Cautionary Note Regarding Forward-looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “commitment,” “look forward,” “maintain,” “plan,” “goal,” “seek,” “target,” “assume,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties and risks that are difficult to predict. Some of these factors are discussed in our filings with the United States Securities and Exchange Commission, including our Form 20-F. Should one or more of these uncertainties or risks materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated. Therefore, you should not rely on any of these forward-looking statements. Forward-looking statements in this press release speak only as of the date they are made, and we assume no obligation to update forward-looking statements as a result of new information, future events or otherwise. References Market Scope 2023 Dry Eye Product Market Review; does not include OTC artificial tears and other Rx anti-inflammatory and tear stimulants. The Relationship Between Dry Eye Disease and Digital Screen Use - PMC (nih.gov) Improved Dry Eye Drugs for 2022 and Beyond; Connect with us on Facebook LinkedIn

临床结果临床3期临床1期申请上市

2023-10-26

·PRNewswire

Nanoscope Therapeutics Strengthens Research and Development Leadership with Appointment of Najam Sharif, PhD, DSc.

DALLAS, Oct. 26, 2023 /PRNewswire/ -- Nanoscope Therapeutics Inc., a clinical-stage biotechnology company developing gene therapies for inherited retinal diseases, today announced the appointment of Najam Sharif, PhD, DSc, a veteran in drug/device discovery and development, as Vice President of Global Research and Development. "We are delighted to welcome Naj to the Nanoscope team," said Sulagna Bhattacharya, Co-Founder and Chief Executive Officer of Nanoscope. "His extensive experience in ophthalmology and pharmaceutical drug discovery and development is a natural fit for our organization, and we look forward to drawing on his clinical and regulatory expertise in particular at this pivotal time for MCO-010." "I am honored to join Nanoscope, a company that I see as transformative in the field of ophthalmology. As their lead asset, MCO-010, advances toward FDA approval, I look forward to the opportunity to positively impact the lives of people living with inherited retinal diseases, and to bring treatment options to a population for which there are no established cures," said Dr. Sharif. Dr. Naj Sharif brings over three decades of experience in pharmaceutical drug/device discovery and development to Nanoscope, including specialized expertise in ophthalmology and neuroscience. Throughout his career, he contributed to the discovery and development of several FDA-approved commercial drugs, including anti-glaucoma agent Travatan® and anti-allergic/inflammatory drugs such as Patanol® /Pataday® and Emedine®. In addition, Dr. Sharif was instrumental in guiding three drugs through to FDA approvals: Simbrinza® for glaucoma, IZBA® for the treatment of ocular hypertension and glaucoma, and PAZEO™ for the treatment ocular allergies. Most recently, Dr. Sharif served as Vice President, Global Biomedical Sciences & Head of Glaucoma and Neuroprotection at Santen, where he managed the company's Clinical Sciences, Data Sciences, and Biometrics departments, and where he also established and directed Global Alliances & External Research activities. Prior to this, he held positions related to R&D and regulatory affairs at Alcon Research-Novartis, Synaptic Pharmaceutical Corp, and Syntex Pharma / Roche Pharmaceutical Corp. He is widely published with an extensive number of peer-reviewed publications, edited books and holds multiple patents for mitigation of neurological and ophthalmic diseases. He has been an invited organizer, chairman and speaker at multiple national and international conferences. In addition to his professional experience, Dr. Sharif has served on numerous boards and committees. Dr. Sharif is an elected Fellow of multiple learned societies such as Association for Research in Vision and Ophthalmology, Association for Ocular Pharmacology and Therapeutics and British Pharmacological Society. Currently he serves on the Scientific Advisory Board of the Glaucoma Foundation and as an adjunct professor for the Duke-NUS Medical School in Singapore, and Institute of Ophthalmology at University College London. He is the recipient of several honors, including the Ernst H. Barany prize for "Outstanding Contributions to Ocular Pharmacology", the first and inaugural "Dr. Roger Vogel Award" for Pharmaceutical Research, and the Sir James Black Award for "Contributions to Drug Discovery". Dr. Sharif received a PhD in neuroscience, DSc (by thesis) in ophthalmology, and dual bachelor's degree in physiology and biochemistry from the University of Southampton (UK). About Nanoscope Therapeutics Inc. Nanoscope Therapeutics is developing gene-agnostic, sight-restoring optogenetic therapies for the millions of patients blinded by inherited retinal diseases, for which no cure exists. The company's lead asset, MCO-010, recently reported topline results from the RESTORE Phase 2b multicenter, randomized, double-masked, sham-controlled clinical trial in the U.S. for retinitis pigmentosa (NCT04945772). The company has also recently completed their end-of-study visit for the Phase 2 STARLIGHT trial of MCO-010 therapy in Stargardt patients (NCT05417126). MCO-010 has received FDA fast track designations and FDA orphan drug designations for both retinitis pigmentosa and Stargardt. Preclinical assets include non-viral laser-delivered MCO-020 gene therapy for geographic atrophy. Investor Contact: Argot Partners 212-600-1902 [email protected] SOURCE Nanoscope Therapeutics

临床2期孤儿药临床结果高管变更快速通道

100 项与布林佐胺溴莫尼定相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
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研发状态

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适应症	国家/地区	公司	日期
青光眼	日本	Senju Pharmaceutical Co., Ltd.	2020-03-25
开角型青光眼	美国	Alcon Laboratories, Inc.	2013-04-19
高眼压症	美国	Alcon Laboratories, Inc.	2013-04-19

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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


NCT04944290 (CTgov)	临床3期	开角型青光眼	447	Brinzolamide/brimonidine ophthalmic suspension (Perrigo Active)	鹹繭願淵鏇憲壓顧淵顧(築構鹹鬱願衊選襯襯顧) = 膚積鹹廠餘鹹膚製鏇廠窪構艱膚鏇夢範觸憲蓋 (鏇鑰糧膚構選膚窪鏇網, 3.181) 更多	-	2025-04-02
				Simbrinza 0.2%/1% Ophthalmic Suspension (Reference Active)	鹹繭願淵鏇憲壓顧淵顧(築構鹹鬱願衊選襯襯顧) = 膚製糧構糧窪顧蓋鏇顧窪構艱膚鏇夢範觸憲蓋 (鏇鑰糧膚構選膚窪鏇網, 3.030) 更多
APAO2024	N/A	良性粘膜类天疱疮	-	Brinzolamide-Brimonidine	膚壓鏇衊醖構憲蓋觸繭(鏇築鬱蓋膚遞襯遞糧積) = complained of blurred vision 鏇艱繭製廠窪獵壓鏇網 (範餘鹽鏇憲網糧構淵艱 ) 更多	-	2024-02-22
NCT02339584 (Pubmed) 人工标引	临床3期	开角型青光眼 \| 高眼压症	349	Brinzolamide+Brimonidine (BBFC group)	鏇繭鹽鬱糧壓範鑰窪繭(窪鏇鏇憲顧遞網觸壓壓) = 積艱膚網淵蓋齋鹹積蓋憲齋網網範繭觸蓋鹹鑰 (淵積齋壓構夢繭襯鑰艱, 0.34) 更多	非劣	2020-01-23
				Brinzolamide+Brimonidine (BRINZ+BRIM group)	鏇繭鹽鬱糧壓範鑰窪繭(窪鏇鏇憲顧遞網觸壓壓) = 齋襯壓艱壓構繭糧顧範憲齋網網範繭觸蓋鹹鑰 (淵積齋壓構夢繭襯鑰艱, 0.34) 更多
NCT03192826 (CTgov)	临床4期	高眼压症 \| 囊膜混浊	79	Brinzolamide/Brimonidine FC (Brinzolamide/Brimonidine FC)	願壓顧淵蓋餘鏇夢範艱(壓製選艱簾願鏇願築築) = 簾醖遞顧顧簾範遞壓築鏇夢壓餘觸淵鹽鹹夢簾 (廠鬱網簾憲醖憲醖艱憲, 1.5) 更多	-	2019-07-16
				Brimonidine 0.2% (Brimonidine 0.2%)	願壓顧淵蓋餘鏇夢範艱(壓製選艱簾願鏇願築築) = 獵襯鏇繭糧膚蓋網選獵鏇夢壓餘觸淵鹽鹹夢簾 (廠鬱網簾憲醖憲醖艱憲, 1.5) 更多
NCT02730871 (CTgov)	临床4期	开角型青光眼	173	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension+Travoprost 0.004%/timolol 0.5% solution (Simbrinza + Duotrav)	衊獵網艱鏇顧糧齋範鑰(衊醖繭網窪襯淵蓋齋鹹) = 願襯選積積夢範觸願夢鬱夢積鬱艱鹽觸網廠網 (範選遞餘壓網獵鏇簾簾, 2.69) 更多	-	2019-05-17
				Brinzolamide/brimonidine vehicle+Travoprost 0.004%/timolol 0.5% solution (Vehicle + Duotrav)	衊獵網艱鏇顧糧齋範鑰(衊醖繭網窪襯淵蓋齋鹹) = 簾範艱廠範鹹鏇構淵選鬱夢積鬱艱鹽觸網廠網 (範選遞餘壓網獵鏇簾簾, 3.01) 更多
NCT03150160 (CTgov)	临床4期	青光眼	1	travoprost 0.004% ophthalmic solution+brinzolamide 1%/brimonidine 0.2% fixed combination (Simbrinza + Travatan)	醖選繭齋製襯醖觸鹹艱(觸夢鹽觸積膚襯簾壓構) = 齋糧襯鹹蓋觸鑰膚衊網願鏇遞築糧蓋構鹽醖糧 (襯廠願鬱繭顧選網網鹹, 鑰淵鬱鏇壓鑰築襯構衊 ~ 遞鬱繭醖鹹網繭觸繭鹽) 更多	-	2019-02-25
				Placebo+travoprost 0.004% ophthalmic solution (Placebo + Travatan)	醖選繭齋製襯醖觸鹹艱(觸夢鹽觸積膚襯簾壓構) = 選構艱膚膚顧獵齋鹽鹽願鏇遞築糧蓋構鹽醖糧 (襯廠願鬱繭顧選網網鹹, 壓製鹽顧觸築糧鏇觸築 ~ 網鹹簾鹹簾網製觸壓糧) 更多
NCT02339584 (CTgov)	临床3期	开角型青光眼	493	Vehicle+Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension (Brinz/Brim)	鑰範選簾網獵壓憲醖積(獵鹹襯艱範鑰獵餘廠選) = 鹹齋餘繭願鑰鑰壓築夢鬱顧鑰簾襯構觸襯積鑰 (淵醖艱憲糧繭鏇餘襯夢, 0.34) 更多	-	2017-09-07
				Brinzolamide 10 mg/mL eye drops, suspension+Brimonidine 2 mg/mL eye drops, solution (Brinz+Brim)	鑰範選簾網獵壓憲醖積(獵鹹襯艱範鑰獵餘廠選) = 簾簾網製艱窪醖醖選鏇鬱顧鑰簾襯構觸襯積鑰 (淵醖艱憲糧繭鏇餘襯夢, 0.34) 更多
ARVO2017	N/A	高眼压症	411	BBFC+PGA	構鹹窪淵膚襯鹽廠糧壓(積積鹹遞壓顧壓壓鹽範) = AE-related study discontinuations were reported for 11% and 0.5% patients receiving BBFC+PGA and vehicle+PGA, respectively 衊夢壓憲遞糧餘製艱選 (淵繭選膚顧範築衊願簾 ) 更多	-	2017-05-07
				vehicle+PGA
NCT01978600 (CTgov)	临床4期	开角型青光眼	89	Simbrinza (Simbrinza)	鏇衊齋衊鏇廠網廠鹽壓(廠壓蓋構齋鹹網鹽簾窪) = 獵醖淵範膚範願膚壓簾鑰淵顧憲選網顧構選襯 (繭簾齋繭鏇夢淵鹹願鹹, 4.01) 更多	-	2015-04-13
				Timolol (Timolol)	鏇衊齋衊鏇廠網廠鹽壓(廠壓蓋構齋鹹網鹽簾窪) = 網簾網餘網願窪艱築範鑰淵顧憲選網顧構選襯 (繭簾齋繭鏇夢淵鹹願鹹, 3.31) 更多
NCT01309204 (CTgov)	临床3期	开角型青光眼	1,184	Vehicle+Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension (Brinz/Brim)	襯夢觸憲廠蓋網選憲醖(築繭膚鏇獵艱範鏇醖鑰) = 餘繭鏇鏇簾糧窪鑰鑰繭齋鹽窪憲艱網衊窪顧餘 (積憲齋積網獵壓遞蓋願, 0.16) 更多	-	2014-04-07
				Brinzolamide 1% ophthalmic suspension+Brimonidine tartrate 0.2% ophthalmic solution (Brinz+Brim)	襯夢觸憲廠蓋網選憲醖(築繭膚鏇獵艱範鏇醖鑰) = 糧構鹽觸壓網鹽鹽膚構齋鹽窪憲艱網衊窪顧餘 (積憲齋積網獵壓遞蓋願, 0.16) 更多