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2026-11-10

申办/合作机构-

CTIS2025-524008-32-00

/ Not yet recruiting临床2期IIT

A phase 2a exploratory study of TAR-0520 gel in prevention of Hand and Foot Syndrome

开始日期2026-03-16

申办/合作机构

Tarian Pharma

NCT07390578

/ Not yet recruiting临床4期IIT

Comparative Effect of Oxymetazoline 0.1% (Upneeq) and Brimonidine 0.025% (Lumify) on Upper Eyelid Position in Acquired Ptosis: A Randomized, Double-Masked, Crossover Study

This study aims to compare the short-term effect of oxymetazoline 0.1% (Upneeq) versus brimonidine 0.025% (Lumify) on upper-eyelid position in adults with acquired ptosis. Participants will undergo standardized eyelid photography, receive a single dose of either Upneeq or Lumify in randomized order, and have repeat photographs approximately 60 minutes later. They will return for a second visit to receive the alternate medication using the same procedures. Eyelid height measurements will be obtained from coded images by masked graders. Data will be analyzed using paired statistical methods appropriate for a crossover design. Both medications are FDA-approved topical ophthalmic drops, and the study involves minimal risk with anticipated transient ocular irritation as the most common adverse event.

开始日期2026-03-01

申办/合作机构

Duke University

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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2,421

项与酒石酸溴莫尼定相关的文献（医药）

2026-01-16·MEDICINE

Neuro-ophthalmic observation and 16-month follow-up of horner syndrome after thyroidectomy: A case report

Article

作者: Yang, Song ; Yang, Bo ; Li, Xiao-Ming ; Liu, Shan-Xue ; Wang, Bo

Rationale::

Horner syndrome (HS) is a rare but underrecognized complication of thyroidectomy, typically resulting from intraoperative injury to the cervical sympathetic chain. Its clinical manifestations include ptosis, miosis, enophthalmos, anhidrosis, and vasodilation. However, data on causative factors, progression of ocular signs, and clinical recovery timing remain limited. This study aimed to clarify these aspects to establish reference intervals for patient management.

Patient concerns::

A 29-year-old female developed postoperative miosis and ptosis following endoscopic thyroidectomy. Her primary concern was persistent ocular symptoms affecting daily life.

Diagnoses::

HS was confirmed through comprehensive evaluation, including ptosis measurement, scotopic pupillometry, and positive response to 0.2% brimonidine testing.

Interventions::

She received intravenous methylprednisolone (80 mg/day for 10 days) and oral methylcobalamin (0.5 mg 3 times daily for 30 days).

Outcomes::

At 16-month follow-up, partial persistence of miosis and ptosis was observed; however, facial sweating normalized, and other ocular symptoms resolved completely.

Lessons::

HS should be considered a potential complication of thyroidectomy, even when rare. Simple clinical and pharmacologic tests (e.g., brimonidine test) suffice for confirmation. Notably, complete recovery from iatrogenic HS secondary to endoscopic thyroidectomy may exceed 12 months, highlighting the need for long-term follow-up and patient counseling.

2026-01-01·ARQUIVOS BRASILEIROS DE OFTALMOLOGIA

Management of glaucoma during pregnancy and lactation: clinical considerations and therapeutic strategies.

Review

作者: Lima, Nubia Vanessa Dos Anjos ; Russ, Heloisa ; Cruz, Denise F Barroso de Melo ; F Netto, Camila ; Gracitelli, Carolina P B ; Maestrini, Heloisa Andrade

Glaucoma is a progressive optic neuropathy that can cause irreversible blindness, though it rarely affects women of reproductive age. Its management during pregnancy and lactation is particularly challenging because of the potential impact of intraocular pressure fluctuations on disease progression and the risks of treatment to both the mother and fetus. Physiological changes in pregnancy, such as decreased intraocular pressure and hormonal alterations, may influence disease activity but do not guarantee disease stability. Preconception counseling plays a key role in mitigating risks and tailoring treatment strategies. Many glaucoma medications carry teratogenic risks, with brimonidine being the only US Food and Drug Administration Category B drug. Surgical interventions - including laser trabeculoplasty and minimally invasive glaucoma surgeries - offer alternative options but require careful timing and consideration of fetal safety. Multidisciplinary collaboration is essential to optimize maternal and neonatal outcomes. This review summarizes evidence-based approaches for glaucoma management during pregnancy and lactation, highlighting clinical considerations, therapeutic strategies, and patient-centered care.

2025-12-25·Cureus Journal of Medical Science

Allergic Reactions to Brimonidine 0.15%: A Case Series

Article

作者: Bastion, Mae-Lynn C ; Mat Nawi, Fatin Nabila

Topical brimonidine is an effective anti-glaucoma agent and is usually well tolerated. This retrospective case series aimed to demonstrate the clinical features of brimonidine 0.15% (Alphagan P; Irvine, CA: Allergan Inc.) allergy. Five cases were found from one ophthalmologist's two-year patient records. Patients' ages ranged from 54 to 80 years. Three patients had ocular diagnoses of well-controlled primary open-angle glaucoma, one had normal-tension glaucoma, and another had ghost cell glaucoma. Brimonidine was combined with other anti-glaucoma medications for nine to 16 months before patients developed eye redness and swelling, which was not distressing. Itchiness was not a prominent symptom. Signs included follicles in the eyelid, bulbar conjunctiva with subtle chemosis, and a bumpy appearance. No patients exhibited marked changes in intraocular pressure during the allergy episode. None of the patients had self-discontinued brimonidine. In all cases, ocular symptoms improved dramatically upon withdrawal. One patient needed additional topical anti-histamine for relief. In brief, brimonidine allergy can occur months after commencement. Unlike other causes of allergic conjunctivitis, patients did not complain of itchiness, and bumpy conjunctival chemosis was a distinguishing feature. Ocular symptoms usually resolved upon cessation of brimonidine.

199

项与酒石酸溴莫尼定相关的新闻（医药）

2026-02-26

·百奥信康

新药速递 | 全球首款治疗老花眼的复方滴眼液Yuvezzi™获FDA批准：双机制协同治疗的里程碑

一、里程碑式获批：老花眼药物治疗的新纪元 2026年1月28日，美国食品药品监督管理局（FDA）批准了Tenpoint Therapeutics公司开发的Yuvezzi™（卡巴胆碱酒石酸溴莫尼定复方滴眼液，2.75%/0.1%），用于治疗成人老花眼（Presbyopia）。这是全球首个也是目前唯一获批的双成分复方滴眼液，标志着老花眼药物治疗从单药时代迈入协同机制时代。老花眼是一种普遍且不可避免的衰老相关疾病，通常始于45岁左右，影响全球约20亿人，美国患者约1.28亿。随着晶状体调节能力逐渐丧失，患者近视力显著下降，严重影响生活质量。尽管光学矫正（老花镜）和手术方案存在，但患者对便捷、可逆的药理学解决方案需求巨大。Yuvezzi的获批填补了这这一未满足需求，为市场提供了首个"全日有效、耐受良好"的复方选择。二、研发溯源：从Visus到Tenpoint的战略整合 Yuvezzi的研发历程体现了生物医药行业典型的"并购整合"模式。该药物最初由Visus Therapeutics开发，代号为Brimochol™ PF。Visus是一家成立于2017年的西雅图生物技术公司，专注于衰老相关眼病的药物治疗。2024年底，Visus与Tenpoint Therapeutics完成战略合并，合并由David Guyer博士（两家公司的董事会主席）主导，旨在整合Visus的后期临床资产与Tenpoint的早期研发管线。合并后的新实体保留了Tenpoint Therapeutics的名称，并获得Yuvezzi（当时为Brimochol PF）的全球权益。Tenpoint迅速推进监管申报：2025年4月提交新药申请（NDA），2025年6月获FDA受理，最终于2026年1月28日获批。从合并到获批仅用时13个月，体现了高效的监管执行力。为支持商业化，Tenpoint完成了2.35亿美元的融资，包括8500万美元B轮股权融资（由Janus Henderson、EQT Nexus、高瓴资本及英国商业银行领投）和1.5亿美元债务融资（Hercules Capital）。公司计划在2026年第二季度（Q2）将Yuvezzi推向美国市场，组建76人销售团队，覆盖12,200名眼科医师。三、药理学机制：双靶点协同的"智能缩瞳" Yuvezzi的核心创新在于其固定剂量复方（FDC）设计，结合了两种机制互补的活性成分：卡巴胆碱（Carbachol，2.75%）——强效胆碱能激动剂卡巴胆碱是一种非选择性胆碱能激动剂，同时激活毒蕈碱受体（M3）和烟碱受体。与第一代老花眼药物毛果芸香碱（Pilocarpine）仅作用于M3受体不同，卡巴胆碱作为完全激动剂，不仅直接刺激虹膜括约肌收缩产生缩瞳（miosis）效应，还能促进副交感神经末梢释放乙酰胆碱，产生更强效、更持久的瞳孔缩小作用。临床前研究显示，2.25%卡巴胆碱的缩瞳效果相当于3%毛果芸香碱，而Yuvezzi采用的2.75%浓度提供了更强的药效基础。酒石酸溴莫尼定（Brimonidine Tartrate，0.1%）——α2-肾上腺素能调节剂溴莫尼定是高选择性α2-肾上腺素能受体激动剂，通过作用于虹膜开大肌（dilator muscle）的突触前神经末梢，抑制交感神经递质释放，从而阻断散瞳机制。更重要的是，溴莫尼定能松弛睫状肌的强直性收缩，增强对瞳孔的选择性作用，减少调节痉挛带来的不适。协同机制与"针孔效应"（Pinhole Effect）两药联用产生协同的"针孔效应"：卡巴胆碱驱动瞳孔收缩（通常缩至2.0-2.5mm），溴莫尼定抑制瞳孔散大并延长缩瞳持续时间。这种组合不仅增加了景深（depth of field），改善近视力，还避免了单用卡巴胆碱可能导致的视力模糊和眼部充血。药代动力学研究揭示了更深层的协同：当卡巴胆碱与溴莫尼定联合使用时，卡巴胆碱在虹膜和睫状体内的滞留量增加了42%，这解释了复方制剂为何能实现更长的作用时间。四、临床开发：BRIO项目的设计与验证 Yuvezzi的获批基于BRIO I和BRIO II两项关键性III期临床试验，共入组800余名患者，代表了老花眼领域规模最大、周期最长的临床研究项目。 BRIO I研究：证明复方优越性（NCT05270863）设计：多中心、随机、双盲、交叉对照试验，入组182名45-80岁的正视眼患者（包括有晶状体和人工晶体眼）。对照：Yuvezzi vs 卡巴胆碱单药 vs 溴莫尼定单药。主要终点：给药后6小时内，双眼未矫正近视力（BUNVA）获得≥15个ETDRS字母（3行）改善，且双眼未矫正远视力（BUDVA）未损失≥5个字母（1行）的患者比例。结果：Yuvezzi在所有时间点均显著优于任一单药组分，满足了FDA对固定剂量复方制剂"证明各组分贡献"的严格要求。在0.5小时，Yuvezzi组27.0%患者达到终点，显著优于溴莫尼定单药（10.8%，p<0.01）；在视力改善幅度上，Yuvezzi组患者平均获得18个字母（近4行）改善，且在10小时内仍维持12个字母改善。 BRIO II研究：长期安全性与安慰剂对照（NCT05135286）设计：多中心、随机、双盲、三臂试验（Yuvezzi vs 卡巴胆碱单药 vs 赋形剂），入组629名患者，在47个美国中心开展。创新点：包含12个月长期安全性随访，累计监测超过72,000个治疗日，为老花眼滴眼液领域迄今最长的安全性研究。主要终点：8小时内BUNVA改善≥3行且BUDVA未损失≥1行的患者比例。疗效结果：Yuvezzi在所有预设时间点均达到主要终点，实现统计学显著意义（p<0.008）。药效持续8-10小时，支持每日一次给药。安全性结果：严重不良事件：12个月治疗期间未报告任何治疗相关严重不良事件（SAE），包括视网膜脱离（RD）。眼部充血：Yuvezzi组发生率仅2.8%，显著低于卡巴胆碱单药组（10.7%），证明了溴莫尼定在改善耐受性方面的价值。常见不良反应：头痛（与睫状肌收缩相关）、短暂视力模糊/昏暗、眼部刺激感，均为轻度且可耐受。值得注意的是，研究纳入了部分既往接受LASIK手术及人工晶体植入患者，显示Yuvezzi具有广泛的适用人群。五、临床优势与差异化定位在老花眼药物治疗市场，Yuvezzi面临已上市的Vuity（毛果芸香碱1.25%，AbbVie）、Qlosi（毛果芸香碱0.4%，Orasis）和VIZZ（醋克立定1.44%，Lenz Therapeutics）的竞争。Yuvezzi通过以下维度建立差异化优势： 1. 复方机制的协同优势持续时间：Yuvezzi提供8-10小时的持续疗效，覆盖完整工作日；相比之下，Vuity通常需每日两次给药（BID）才能维持全天效果，Qlosi標示给药为BID。起效速度：30分钟内起效，与VIZZ相当（30分钟），快于部分患者对Vuity的反应。 2. 瞳孔大小的精准控制根据Charman和Whitefoot曲线，最佳景深改善对应的瞳孔直径约为1.5-2.0mm。VIZZ（醋克立定）可实现<2.0mm的瞳孔直径，但可能伴随更明显的视力昏暗；Yuvezzi产生2.0-2.5mm的中等瞳孔，在景深改善与视觉质量间取得平衡；Vuity和Qlosi产生的瞳孔较大（2.3-2.5mm），景深改善相对有限。 3. 安全性与耐受性眼部充血：Yuvezzi的充血率（2.8%）显著低于卡巴胆碱单药，且溴莫尼定本身具有血管收缩作用，可"对抗"卡巴胆碱引起的充血，实现"改善视力+外观友好"的双重获益。无防腐剂配方：与Qlosi和VIZZ一样，Yuvezzi采用无防腐剂（PF）配方，对干眼症患者更友好，而Vuity含防腐剂。视网膜安全性：尽管醋克立定因最小化睫状肌刺激被认为可降低视网膜脱离风险，但Yuvezzi的12个月数据显示无视网膜脱离病例，且卡巴胆碱在既往青光眼应用中已证明长期安全性。 4. 给药便利性每日一次（QD）给药是Yuvezzi的核心便利优势，相较于需每日两次的Qlosi和多数需补充给药的Vuity方案，患者依从性更佳。六、市场前景与竞争格局全球老花眼及近视治疗滴眼液市场预计从2024年的12亿美元增长至2033年的25亿美元，年复合增长率（CAGR）约8.5%。Yuvezzi进入市场时，面临以下竞争态势： Yuvezzi的商业化成功将取决于其能否证明"复方价值"——即单药无法实现的全天候疗效与耐受性平衡。Tenpoint的76人销售团队将 targeting 12,200名眼科医师，重点强调BRIO研究的长期安全性数据和"工作时长覆盖"的临床价值。此外，Tenpoint已与兆科眼科（Zhaoke Ophthalmology，6622.HK）达成战略合作，授权后者在亚太8国及中东6国开发和商业化该药物，体现了其全球化布局。七、结语 Yuvezzi的获批代表了老花眼药物治疗的重要范式转变——从单一机制向多靶点协同、从短效补救向全日管理、从单一疗效向疗效-耐受性平衡转变。其双成分复方设计不仅提供了8-10小时的持久近视力改善，更通过溴莫尼定的加入显著降低了眼部充血这一影响患者接受度的关键障碍。作为Tenpoint Therapeutics的首个上市产品，Yuvezzi承载着验证"衰老眼部"治疗策略的使命。随着2026年第二季度的商业上市，该药物将与Vuity、Qlosi和VIZZ共同塑造老花眼药物市场的竞争格局。其长期市场表现将取决于真实世界中的耐受性数据、医师对复方制剂的接受度，以及能否在"足够缩瞳"与"避免视觉副作用"之间找到最佳平衡点。对于全球20亿老花眼患者而言，Yuvezzi的出现提供了首个真正意义上的"全日有效、外观友好"的药理学解决方案，标志着人类对抗衰老相关视觉衰退迈出了坚实一步。关于Tenpoint Therapeutics Tenpoint Therapeutics公司是一家全球生物科技公司，专注于商业化推广Yuvezzi（卡巴胆碱酒石酸溴莫尼定复方滴眼液）2.75%/0.1%——这是首个也是目前唯一用于治疗老花眼的双效复方滴眼液。该疾病在美国影响近 1.28 亿人，全球范围内约影响 20 亿人。Tenpoint Therapeutics公司通过洞察真实世界需求，并与眼科医护专业人士紧密合作，致力于为衰老的眼睛带来创新治疗方案。 ✦ 关于我们江苏百奥信康医药科技有限公司是一家以新药研发驱动制药全产业链发展的高科技创新型医药企业，也是国家高新技术企业、江苏省专精特新中小企业。百奥信康聚焦改良型新药，已构建纳米胶束、人工智能及转录组大数据两大核心技术平台。百奥信康以研发自我持有的改良型新药为主业，同时为国内外客户提供改良型新药研发服务。百奥信康致力于做中国最成功的改良型新药！版权及免责声明「百奥信康」公众号推送的内容来源于原创或根据公开资料整理编辑，欢迎个人转发至朋友圈。媒体或机构如需转载，请完整注明：（1）本文转载自百奥信康公众号（ID: BioScenePharma）；（2）作者栏请填写：百奥信康；（3）插入百奥信康公众号链接。本公众号的目的在于分享行业相关知识、传递最新医药资讯。如有侵权，请在留言栏及时告知，我们将及时删除相关信息。本公众号推送的文章中的观点不代表百奥信康的立场，也不是治疗方案的推荐。如需获得诊断或治疗方面的指导，请前往正规医院就诊。

申请上市上市批准引进/卖出

2026-02-24

·Business Wire

Ophthalmology and Therapy Publishes Findings Showing Lifestyle-Driven Rise in Ocular Redness and Differentiated Role of LUMIFY®

Global review highlights increasing prevalence of noninfectious ocular redness due to digital eye strain, dry eye disease, allergies and environmental exposures LUMIFY redness reliever eye drops (brimonidine tartrate 0.025%) are highlighted as a differentiated OTC option due to its highly selective α2 mechanism, with no tachyphylaxis over 29 days and virtually no rebound redness Review also notes a preservative-free formulation of brimonidine tartrate 0.025% showing comparable efficacy, safety and tolerability; Bausch + Lomb introduced LUMIFY Preservative Free Eye Drops in 2025 VAUGHAN, Ontario--(BUSINESS WIRE)--Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, announced today that Ophthalmology and Therapy published a new global narrative review examining the causes, burden and management of noninfectious conjunctival hyperemia (ocular redness). The review highlights the growing global prevalence of ocular redness driven by digital lifestyles, dry eye, contact lens wear, allergies and environmental factors, reinforcing how ocular redness affects both comfort and appearance.1 Developed by clinical experts from nine countries, the publication underscores the aesthetic and psychosocial impact of ocular redness, noting that individuals with red eyes may be perceived as less healthy or more fatigued – a concern amplified by video conferencing and social media, which spotlight facial features, including the eyes and the periocular region. The authors also note that ocular redness frequently presents symptoms such as irritation, dryness, itching or foreign-body sensation, contributing to patient discomfort and reduced quality of life. “Ocular redness is no longer just a clinical concern, it’s a global lifestyle and quality-of-life issue,” said Melissa Toyos, MD, lead author of the review and partner, Toyos Clinic, Nashville, Tenn. “Patients today are seeking effective, safe and aesthetically minded products, which makes understanding the differences in products more important than ever.” Key clinical insights from the paper: Rising prevalence: Noninfectious conjunctival hyperemia is rising worldwide due to digital eye strain, dry eye disease, allergies, contact lens wear and environmental factors Limitations of traditional decongestants: Traditional α1 and mixed α1/α2 decongestants may provide short-term symptom relief but are prone to tachyphylaxis, rebound redness and shorter duration of effect Impact on comfort and appearance: Ocular redness is often accompanied by symptoms such as irritation and dryness, and may adversely affect quality of life due to both discomfort and aesthetic concerns Evidence for brimonidine tartrate 0.025%: Brimonidine tartrate 0.025% (LUMIFY Redness Reliever eye drops), a highly selective α2-adrenergic receptor (AR) agonist, demonstrated effective redness reduction with no tachyphylaxis over 29 days and virtually no rebound redness after discontinuation Aesthetic-driven OTC use: Patients increasingly seek safe OTC redness-relief products for aesthetic reasons, highlighting the importance of selective mechanisms and favorable safety profiles Need for patient education: Global gaps exist in patient awareness and clinical guidance, underscoring the importance of patient education, appropriate OTC product selection and awareness of safety considerations, especially amid increasing global self-treatment and concerns with unsafe or unapproved copycat or counterfeit redness relievers “This publication reinforces the unique, mechanism-based advantages of LUMIFY,” said Mayssa Attar, senior vice president, Pharmaceuticals and Consumer R&D, Bausch + Lomb. “The evidence supporting selective α2-AR agonist mechanism clearly differentiates LUMIFY’s established safety and efficacy profile and reflects our commitment to delivering trusted, science-backed products for consumers.” LUMIFY, formulated with low-dose brimonidine tartrate 0.025%, provides fast, effective redness reduction while avoiding tachyphylaxis and rebound redness associated with traditional decongestants. Its highly selective α2-AR agonist mechanism primarily constricts venules rather than arterioles, contributing to a favorable safety profile, tolerability and efficacy. Clinical evidence across four trials demonstrated no tachyphylaxis over 29 days and virtually no rebound redness upon discontinuation. The review also notes a preservative-free formulation of brimonidine tartrate 0.025%, which demonstrated efficacy, safety and tolerability comparable to the original version with virtually no rebound redness. In 2025, Bausch + Lomb introduced LUMIFY Preservative Free Eye Drops in convenient single-use vials, offering patients an additional brimonidine-based option without preservatives. For more information on LUMIFY and LUMIFY Preservative Free, visit www.lumifyeyes.com. About Ocular Redness Ocular redness, or conjunctival hyperemia, is a common condition that occurs when tiny blood vessels on the surface of the eye become enlarged or irritated, causing the eye to appear red or bloodshot. It can be caused by factors such as digital eye strain, dry eye disease, allergies, contact lens wear and environmental irritants. Mild redness can be accompanied by irritation or dryness and can impact comfort, appearance and confidence, prompting many people to seek over-the-counter relief.2 About LUMIFY Redness Reliever Eye Drops LUMIFY is a redness reliever like no other. With its novel mechanism of action and favorable safety profile, LUMIFY has redefined the category and become an eye care staple – helping eyes look whiter, brighter and more beautiful. It’s the No. 1 eye doctor-recommended redness reliever eye drop brand and holds more than 60% market share. LUMIFY works in one minute and lasts up to eight hours when used as directed. In 2025, Bausch + Lomb introduced LUMIFY Preservative Free Eye Drops in convenient, single-use vials. For more information, visit www.lumifyeyes.com. About Bausch + Lomb Our mission is simple – we help people see better to live better, all over the world. For nearly two centuries we’ve evolved with the changing needs of patients and customers, and our commitment to innovation and improving the standard of care in eye health has never been stronger. From contact lenses to prescription products, over-the-counter options, surgical devices and more, we’re turning bold ideas into better outcomes through passion, perseverance and purpose. Learn more at www.bausch.com and connect with us on Facebook, Instagram, LinkedIn, X and YouTube. References Toyos M, Chan CC, Alio JL, Chong KKL, Pek D, Doan S, Sinjab M, Hosny M, Messmer EM, Giannaccare G. “Global Perspectives on Therapy for Noninfectious Conjunctival Hyperemia: A Narrative Review.” Ophthalmology and Therapy. 2026. https://doi.org/10.1007/s40123-026-01310-7 . Cleveland Clinic. Red Eye: Causes, Treatment & Prevention. 2023. https://my.clevelandclinic.org/health/symptoms/17690-red-eye . ©2026 Bausch + Lomb. LUM.0051.USA.26

临床结果

2026-02-24

·药通社

50亿美元大药，首仿仍未出现！

盐酸毛果芸香碱滴眼液的仿制，近年非常受业内关注。盐酸毛果芸香碱滴眼液自23年开始，累计批了14张仿制临床批件，对一个较为小众的眼科领域，属实罕见。图源：摩熵医药盐酸毛果芸香碱滴眼液算得上一款眼科神药，这是FDA批准的第一款用于治疗老花眼的眼药水，由艾伯维旗下艾尔建研发。 2021年，艾尔建宣布，FDA批准了Vuity（盐酸毛果芸香碱眼用溶液）1.25%，用于治疗成人老视（老花眼）。其实毛果芸香碱眼用最开始用于治疗青光眼，即硝酸毛果芸香碱滴眼液，艾尔建在其基础上改动了酸根，以505(b)(2)改良上市。彼时资本市场非常看好艾伯维这款滴眼液以及老花眼药物市场，多家国外证券机构预测老花眼市场至少能达到年30-50亿美元。但从实际销售情况来看，艾伯维这款神药较预期存在很大差距，截至2025年艾伯维发布三个季度的销售数据，Vuity并未被单独列出，而是与Xen凝胶支架等设备合并算入“其他眼部护理”，这部分产品合计总销售额才仅达到2.48亿美元。 2023年，全球第二款老花眼药物上市，由ORASIS公司研发的0.4%浓度毛果芸香碱滴眼液Qlosi在FDA获批，Vuity是多剂量包装，需要防腐剂，而Qlosi是单剂量包装，不含防腐剂，且低浓度使不良反应发生概率减少，因此ORASIS公司凭着一款产品在2024年融资7800W。目前这两款产品均已被纳入参比目录，从目前有临床进度的企业来看，因单剂量不含防腐剂，技术要求更高，大部分都选择了艾尔建的1.25%含量进行仿制。其中很多眼科龙头企业，比如国内“OK镜一哥”欧普康、眼科王牌莎普爱思等均获批了临床。其中莎普爱思的临床批件是2023年从南京恒道花费952万元买入，发布公告后莎普爱思连日涨停，足见资本市场多看好此品种，目前山东华铂凯盛和南京正科已完成Ⅲ期临床提交了上市申请。此品种上市需要相当长的时间和精力，至今首仿未出。进度最快的是山东华铂凯盛和南京正科医药，已在2025年提交上市申请，正在等待评审中。放眼全球，目前已上市的老花眼药物并不多，仅4款，除了上文提到的Vuity和Qlosi外，还有两款分别是： VIZZ（2025年7月FDA批准）：由LENZ THERAP公司研发，含1.44%醋克利定，为首款醋克利定类眼药水，每日用药1次，30分钟起效，维持显著改善视力效果长达10小时。 YUVEZZI（2026年1月FDA批准）： Tenpoint公司研发，是含卡巴胆碱与溴莫尼定的复方制剂，这是FDA批准的首款用于治疗老花眼的复方滴眼液。Yuvezzi同样采用每日一滴给药方案，可在30分钟内起效，持续长达10小时，从而改善近视力。与盐酸毛果芸香碱成分滴眼液原研未在国内上市不同，这两款药物原研均已选择跟国内企业达成合作，不日就将进入国内。 2022年4月，箕星获得醋克利定滴眼液的大中华区权益，包括港澳台。根据协议，箕星支付首付款1500万美元，1500万美元开发里程碑付款，8000万美元销售里程碑付款，以及基于净销售额5%到15%分级销售分成或者在产品批准前再授权收入15%到5%。目前盐酸醋克利定滴眼液的上市申请已于25年7月获CDE受理。图源：摩熵医药另一款2022年5月，兆科眼科与Tenpoint签订独家许可协议，获得Yuvezzi在大中华区、韩国及指定东南亚地区的开发与商业生产权；2024年2月，双方进一步扩大合作，将授权区域拓展至更多市场。在国内，兆科眼科正在开展 Yuvezzi用于治疗老花眼的Ⅱ期临床。这一小众领域用药，要卷起来了！ ↓⭐关注药通社，洞见行业趋势↓ 投稿/企业合作/内容沟通：药通社总编—华籍美人（Ww_150525） *添加请注明备注及来意

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,

后查看更多信息

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,

后查看更多信息

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
先天性毛细血管畸形1	临床3期	加拿大	-	2016-06-01
充血	临床3期	美国	Bausch & Lomb, Inc.	2013-11-07
红斑	临床3期	瑞典	-	2013-05-09
周围神经系统疾病	临床2期	法国	Tarian Pharma	2025-09-01
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 UC	2009-11-01
视网膜脱离	临床2期	印度	Allergan UC	2009-11-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


BusinessWire 人工标引	临床3期	眼睛发红	380	LUMIFY Preservative Free	襯壓餘蓋鹽鏇鬱遞壓觸(觸鹹構夢餘齋鑰糧糧衊) = The study met its primary objective, confirming that LUMIFY Preservative Free is statistically non-inferior to LUMIFY in reducing ocular redness in adults. 醖齋鹹艱簾窪製壓艱築 (繭願繭選窪憲遞壓鹽積 ) 达到更多	非劣	2025-07-29
				LUMIFY
NCT05591755 (CTgov)	临床3期	季节性过敏性结膜炎	229	Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution (Brimonidine Tartrate 0.025%/ Ketotifen Fumarate 0.035% Ophthalmic Solution)	餘鹹膚製鑰壓鏇積鏇窪(夢顧鹹壓襯餘築願膚壓) = 網願齋遞襯憲選淵選鹹積齋鏇鬱襯鹽網構獵襯 (選壓餘願襯鏇鹹遞構廠, 0.6031) 更多	-	2025-07-01
				Ketotifen fumarate ophthalmic solution 0.035% (Ketotifen Fumarate Ophthalmic Solution 0.035%)	餘鹹膚製鑰壓鏇積鏇窪(夢顧鹹壓襯餘築願膚壓) = 簾顧範積願夢憲選顧鹹積齋鏇鬱襯鹽網構獵襯 (選壓餘願襯鏇鹹遞構廠, 0.3136) 更多
NCT05579730 (CTgov)	临床3期	变应性结膜炎	188	Brimonidine tartrate+ketotifen fumarate (Combination)	築廠齋艱顧鹹鏇襯鬱醖(齋鏇構窪鏇醖糧醖憲膚) = 憲餘艱醖範繭製鹽願壓餘廠齋觸顧範觸鹹餘範 (觸鹽網醖範鬱範顧鏇壓, 0.1464) 更多	-	2025-02-14
				Ketotifen Fumarate 0.035% (Ketotifen Fumarate)	築廠齋艱顧鹹鏇襯鬱醖(齋鏇構窪鏇醖糧醖憲膚) = 積蓋鏇顧膚糧製遞網憲餘廠齋觸顧範觸鹹餘範 (觸鹽網醖範鬱範顧鏇壓, 0.1487) 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)	觸衊構鏇選鑰蓋獵衊鬱(衊範襯製積構憲廠獵蓋) = 顧鏇構觸積膚膚繭築築襯繭餘簾艱餘選觸齋鑰 (簾鏇夢襯鑰餘遞窪齋艱, 0.039) 更多	-	2024-08-26
				Lumify® (brimonidine tartrate ophthalmic solution 0.025%) (Lumify®)	觸衊構鏇選鑰蓋獵衊鬱(衊範襯製積構憲廠獵蓋) = 範艱糧選遞遞憲膚遞範襯繭餘簾艱餘選觸齋鑰 (簾鏇夢襯鑰餘遞窪齋艱, 0.041) 更多
NCT03418727 (CTgov)	临床2期	干眼综合征	84	Corticosteroid+Brimonidine (Brimonidine and Corticosteroid Combination Therapy)	夢餘繭膚簾構艱觸鬱選(廠艱艱鏇繭廠蓋壓淵範) = 夢夢艱淵夢襯夢衊糧廠膚鹽願夢鹹廠蓋築簾襯 (繭醖壓願簾鹹構窪廠廠, 襯壓廠製廠衊膚襯積範 ~ 夢築積製積蓋鏇願鬱憲) 更多	-	2022-07-06
				Brimonidine (Brimonidine Monotherapy)	夢餘繭膚簾構艱觸鬱選(廠艱艱鏇繭廠蓋壓淵範) = 鬱夢憲憲網齋壓膚簾鏇膚鹽願夢鹹廠蓋築簾襯 (繭醖壓願簾鹹構窪廠廠, 衊餘獵窪鑰襯積齋顧顧 ~ 醖蓋壓糧壓餘鑰鹽鏇衊) 更多
NCT03785340 (CTgov)	临床3期	干眼综合征	252	Brimonidine Tartrate	獵齋築窪鏇遞艱選獵觸(窪觸製艱鬱顧糧範膚製) = 繭鹹餘齋襯範夢餘淵廠選壓醖鹹襯網顧膚範鏇 (築醖艱繭簾製醖鏇繭遞, 13.6) 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%)	艱襯艱襯鹽鬱廠鹽鹽鑰(遞窪艱繭顧獵觸襯齋鏇) = 壓膚壓膚壓積鹹憲網鹽壓鏇簾製選鑰鏇餘鏇顧 (膚糧衊願鹹獵繭衊糧鏇, 2.57) 更多	-	2022-04-20
				Brimonidine Tartrate (Control - Untreated)	艱襯艱襯鹽鬱廠鹽鹽鑰(遞窪艱繭顧獵觸襯齋鏇) = 選繭壓遞選築夢衊醖窪壓鏇簾製選鑰鏇餘鏇顧 (膚糧衊願鹹獵繭衊糧鏇, 1.20) 更多
NCT03450629 (CTgov)	临床3期	开角型青光眼	682	Brimonidine Tartrate Ophthalmic Suspension (PDP-716)	襯糧醖願築鹽鬱蓋遞鹽(顧獵憲鹹觸鏇願願廠繭) = 壓蓋鏇鏇艱鹽繭窪襯簾壓鹽選鏇壓鹽鬱構鹽壓 (淵獵廠範衊餘鏇蓋網鹽, 3.746) 更多	-	2022-02-15
				Brimonidine Tartrate Ophthalmic Solution (Brimonidine Tartrate Ophthalmic Solution)	襯糧醖願築鹽鬱蓋遞鹽(顧獵憲鹹觸鏇願願廠繭) = 網顧觸觸淵鏇繭膚憲鏇壓鹽選鏇壓鹽鬱構鹽壓 (淵獵廠範衊餘鏇蓋網鹽, 3.724) 更多
NCT03782701 (CTgov)	临床4期	眼睑下垂	43	Brimonidine tartrate ophthalmic solution 0.025% (Lumify Eye Drop)	壓夢顧憲積蓋築夢糧觸(夢壓鹹願選簾艱繭憲蓋) = 蓋淵淵觸夢觸簾獵選鑰膚鏇製鹹鹽鏇鑰鬱襯齋 (顧築鏇顧壓築醖遞蓋壓, 1.71) 更多	-	2021-06-14
				Sterile balanced saline solution (Saline Solution Eye Drop)	壓夢顧憲積蓋築夢糧觸(夢壓鹹願選簾艱繭憲蓋) = 觸鑰鬱網艱艱繭簾鏇觸膚鏇製鹹鹽鏇鑰鬱襯齋 (顧築鏇顧壓築醖遞蓋壓, 1.62) 更多
NCT03323164 (CTgov)	临床4期	开角型青光眼	35	Brimonidine Tartrate (Brimonidine)	餘選膚醖鑰膚觸獵積製(製鏇構夢構願鏇憲顧簾) = 蓋蓋夢淵積醖淵蓋鏇餘鹹鹹積獵齋繭繭遞廠醖 (艱簾獵蓋獵繭範繭構壓, 6.10) 更多	-	2020-12-31
				Timolol Maleate (Timolol)	餘選膚醖鑰膚觸獵積製(製鏇構夢構願鏇憲顧簾) = 糧鹽膚積糧鬱築艱醖齋鹹鹹積獵齋繭繭遞廠醖 (艱簾獵蓋獵繭範繭構壓, 6.47) 更多