The objective of this study is to evaluate abicipar pegol for safety and treatment effects in participants with neovascular age-related macular degeneration (AMD).

开始日期2018-05-25

申办/合作机构

Allergan UC

NCT03335852

/ Completed临床1期

Evaluation of Safety and Systemic Pharmacokinetics After Abicipar Pegol (AGN-150998) Intravitreal Injections in Japanese Patients With NEovascular Age-Related Macular Degeneration (PINE Study)

This study will evaluate the safety and to characterize the systemic pharmacokinetics of free and vascular endothelial growth factor (VEGF)-bound abicipar following multiple monthly intravitreal injections of abicipar in Japanese patients with neovascular age-related macular degeneration (AMD).

开始日期2017-11-28

申办/合作机构

Allergan UC

NCT02859766

/ Completed临床1期

Evaluation of Safety and Systemic Pharmacokinetics After Single and Repeat Doses of Abicipar Pegol (AGN-150998) Intravitreal Injections in Patients With Neovascular Age-Related Macular Degeneration

This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of free and vascular endothelial growth factor (VEGF)-bound abicipar following single and multiple intravitreal injections of abicipar pegol in treatment-naïve patients with neovascular age-related macular degeneration (AMD).

开始日期2016-12-07

申办/合作机构

Allergan UC

100 项与 Abicipar pegol 相关的临床结果

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100 项与 Abicipar pegol 相关的转化医学

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100 项与 Abicipar pegol 相关的专利（医药）

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项与 Abicipar pegol 相关的文献（医药）

2024-10-02·Expert Opinion on Drug Metabolism & Toxicology

Intraocular drugs: pharmacokinetic strategies and the influence on efficacy and durability

Review

作者: Stewart, Michael W.

INTRODUCTION:

The modern treatment of chorioretinal vascular diseases follows the recent development and rapid adoption of drugs that inhibit vascular endothelial growth factor (VEGF). All anti-VEGF drugs are delivered intravitreally, with clinical behavior, including efficacy, durability, and safety, largely determined by their pharmacokinetic properties.

AREAS COVERED:

Properties of these new drugs include additional binding targets (placental growth factor (PlGF) and angiopoietin 2 (Ang 2)), binding affinity, potency, intravitreal half-life, and increased molar dose. A PubMed search for 'pharmacokinetics of anti-VEGF drugs' was performed from 2000 to 2023. Relevant studies were reviewed and referred to in the manuscript.

EXPERT OPINION:

Early developers concentrated on improving efficacy, but since maximum efficacy with VEGF inhibition has been reached, development has pivoted to extending the duration of action. Durability strategies include inhibiting additional pathways (faricimab), increasing molar dose (abicipar, brolucizumab, faricimab, and aflibercept 8 mg), and prolonging the intravitreal half-life (abicipar and KSI-301). Recent phase 3 trials demonstrated modest improvements in durability, but failures that might be attributed to these strategies (conjugation and manufacturing processes) have occurred. Future drug development focuses on extending duration of action with implantable reservoirs (ranibizumab port delivery system), sustained release devices (tyrosine kinase inhibitors), and gene therapy.

2023-05-05·Vestnik oftalmologii

Modern trends in anti-VEGF therapy for age-related macular degeneration

Article

作者: Budzinskaya, M.V. ; Alkharki, L. ; Plyukhova, A.A.

Age-related macular degeneration (AMD) develops in people aged 50 years and older, its pathogenesis involves progressive destruction of the retinal pigment epithelium and Bruch’s membrane. There are eight currently known anti-VEGF drugs for treating the neovascular form of AMD, four of them have already been registered and are used in clinical practice. The first registered drug was pegaptanib, which selectively blocks VEGF165. Subsequently, a molecule with a similar mechanism of action was developed and named ranibizumab, which is a humanized monoclonal Fab fragment; it was specifically designed for ophthalmology. Its advantage over pegaptanib was neutralization of all active VEGF-A isoforms. Aflibercept and conbercept are recombinant fusion proteins that act as soluble decoy receptors for VEGF family proteins. Phase III data from the VIEW 1 and 2 studies showed that intraocular injections (IVI) of aflibercept every 1 or 2 months for a year resulted in comparable functional outcomes to monthly IVI of ranibizumab for one year. The next molecule for anti-VEGF therapy that showed effectiveness was brolucizumab — a single-chain fragment of a humanized antibody that binds with high affinity to various VEGF-A isoforms. Simultaneously with studying brolucizumab, another study was conducted involving Abicipar pegol, but that drug showed a high rate of complications. The latest drug registered for the treatment of neovascular AMD is faricimab. The molecule of this drug is a humanized immunoglobulin G antibody that acts on two key points of angiogenesis: VEGF-A and angiopoietin-2 (Ang-2). Thus, the strategy for advancing anti-VEGF therapy lies in the development of molecules with greater efficiency (better effect on newly formed vessels leading to resorption of exudate in the retina, under the neuroepithelium and under the retinal pigment epithelium), which allows not just to preserve vision, but to also significantly improve it when there is no macular atrophy.

2023-01-01·Clinical Ophthalmology

Impact of Modifying Abicipar Manufacturing Process in Patients with Neovascular Age-Related Macular Degeneration: MAPLE Study Results.

作者: Callanan, David ; Li, Xiao-Yan ; Le, Grace ; Attar, Mayssa ; Mehta, Shraddha ; Hassan, Tarek ; Khanani, Arshad M ; Badger, Hanh ; Seal, Jennifer ; Eichenbaum, David ; Maturi, Raj K ; Khurana, Rahul N ; Wykoff, Charles C ; Patel, Sunil

Purpose:

To evaluate the impact of modifying the abicipar pegol (abicipar) manufacturing process on the safety and treatment effect of abicipar in patients with neovascular age-related macular degeneration (nAMD).

Methods:

A new process for manufacturing abicipar was developed to reduce host cell impurities. In a prospective, Phase 2, multicenter, open-label, 28-week clinical trial, patients (n=123) with active nAMD received intravitreal injections of abicipar 2 mg at baseline (day 1) and weeks 4, 8, 16, and 24. Outcome measures included proportion of patients with stable vision (<15-letter loss from baseline; primary endpoint), change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), and adverse events.

Results:

Overall, 8.9% (11/123) of patients experienced intraocular inflammation (IOI) and discontinued treatment. IOI cases were assessed as mild (2.4% [3/123]), moderate (4.9% [6/123]), or severe (1.6% [2/123]) and resolved with steroid treatment. Visual acuity in most patients with IOI (8 of 11) recovered to baseline BCVA or better by study end. No cases of endophthalmitis or retinal vasculitis were reported. Stable vision was maintained for ≥95.9% (≥118/123) of patients at all study visits. At week 28, treatment-naïve patients showed a greater mean improvement from baseline in BCVA compared with previously treated patients (4.4 vs 1.8 letters) and a larger mean CRT reduction from baseline (98.5 vs 45.5 μm).

Conclusion:

Abicipar produced using a modified manufacturing process showed a moderately lower incidence and severity of IOI compared with Phase 3 abicipar studies. Beneficial effects of treatment were demonstrated.

项与 Abicipar pegol 相关的新闻（医药）

2023-12-05

·生物制药小编

眼科畅销药躲过安全风暴

近日，FDA更新了Apellis公司补体C3抑制剂Syfovre的安全说明，对于之前备受关注的与视网膜血管炎病例，新增说明部分并不如之前大家预想的那般严厉，FDA并没有给予黑框警告，只是做了相关风险提示。该消息公布后，Apellis股价上涨了14.3%。对于一款眼科药物来说，其安全性是决定其市场接受度最首要的因素。此次惊险渡过安全性风波，对于高度依赖Syfovre的Apellis而言无疑松了一大口气。首款补体C3抑制剂Apellis开发的一款合成环肽，通过靶C3，提供对补体级联反应的全面控制。目前pegcetacoplan已获批了两个适应症。首个适应症阵发性睡眠性血红蛋白尿症（PNH）于2021年5月被FDA批准，商品名为empaveli，是首款获批的补体C3抑制剂。PNH第二个适应症年龄相关性黄斑变性(AMD)相关的继发性地图样萎缩在今年2月获得FDA批准，商品名Syfovre，为全球首款GA治疗药物。遭遇安全性风暴不过今年7月，Syfovre报告了令人担忧的严重不良事件--视网膜血管炎，Apellis确认总共6例视网膜血管炎事件，包括4例闭塞性（存在致盲可能），2例非闭塞性。对于一款眼科药物而言，一旦出现类似视网膜血管炎可能致盲的严重不良事件，会极大的增加其风险/收益率。艾伯维的眼科药物abicipar pegol（治疗nAMD）就因为观察到的眼内炎症率，导致其在美的上市申请被FDA驳回。即便最终通过了监管批准，如果后期报告了类似不良事件，市场接受度也会大大折扣。如诺华的Beovu，作为诺华推出的新一代抗VEGF药物，虽然对比前辈阿柏西普存在明显的给药优势，但临床试验中报道的眼内炎症发生率更高（约前者的一倍)。上市不久，美国视网膜专家协会（ASRS）发布了Beovu的安全性报告，有11例报告了阻塞性视网膜血管炎事件，诺华也确认了这一严重副作用风险。FDA为此在其产品说明书上也添加了黑框警告。这一事件直接限制了其市场渗透，2023前三季度累计销售收入仅为1.51亿美元，与最初的预期销售额有着天壤之别。Syfovre的这一也引发强烈的事件，随即引发强烈的市场担忧，Apellis股价连跌数天。在调查期间，三分之二眼科医生认为该事件医生认为该事件将对未来治疗处方量产生重大影响，公司方面也承认了该严重不良事件可能会影响患者使用。不久Apellis宣布了裁员计划，占比25%（225名员工），并放弃了两条临床前管线，重点推进Syfovre的商业化。8月22日，公司正式发布了调查结果，将该安全事件归因于一种注射针头，公司在调查期间，发现部分注射器中19号过滤针的内部结构有变，公司随后建议立即停止使用19号过滤针。该消息发布后，市场对公司这一解释给出了积极反应，公司股价有所反弹，从30.76美元/股升至40.65美元/股，上涨了32%。公司营收的主力因为GA此前没有任何批准的治疗方案，作为其首款治疗药物，Syfovre上市以来迅速打开了市场，并且大幅甩开其第一个获批适应症的销售额（empaveli上市第一年销售额为6500万美元），成为公司营收的主力。根据公司各季度财报，上市的第一个月（3月1日 - 3月31日），销售额就达到1840 万美元，远超市场预期。Q2季度6730万美元，Q3季度7530万美元。今年的累计销售额超过1.6亿美元。相关分析师预测，Syfovre最终将在年销售额峰值达到30亿美元。目前，Syfovre在欧盟、加拿大、澳大利亚、英国和瑞士等国家用于治疗GA的上市申请正在审批中。参考出处:https://endpts.com/apellis-eye-disease-drug-gets-safety-label-update-for-rare-inflammation-side-effect/https://investors.apellis.com/news-releases/news-release-details/apellis-pharmaceuticals-reports-third-quarter-2023-financial小小针头会是不良事件原因吗？

医药出海申请上市临床研究紧急使用授权

2023-01-11

·FierceBiotech

JPM23, Day 3: Ionis CEO concedes PCSK9 ship may have sailed; Nektar forges ahead after bempeg blowup

While M&A deals may have dried up on Day 2, we're still holding out hope for a JPM-defining blockbuster acquisition. We're off for another day of the J.P. Morgan Healthcare Conference. The flood of licensing agreements may have slowed, but there's still plenty of action to come as companies make pitches to their peers, investors and industry watchers. Some notable highlights from yesterday included Sage Therapeutics setting out its stall for depression drug zuranolone, while Karuna Therapeutics suggested that it didn’t need to take advantage of swirling acquisition rumors to scale up its hotly anticipated schizophrenia drug. And while M&A deals may have dried up on Day 2, we're still holding out hope for a JPM-defining blockbuster acquisition. If that happens, you'll hear about it right here. Our Day 1 conference tracker is available here, and all the Day 2 action is wrapped here. Fierce Pharma’s take on the action so far can be found here and here. 6:05 p.m. ET: It appears that Ionis’ PCSK9 hopes are dimming. CEO Brett Monia told Fierce Biotech in an exclusive interview that the recently returned drug does not fit the company’s plans. The med, ION449, was returned to Ionis from AstraZeneca following a phase 2 data readout last year. The prospects of the company’s factor XI med, fesomersen, are more promising, however. Story 1:08 p.m. ET: Annexon Biosciences CEO Douglas Love said the company is giving itself "two ways to win” in the upcoming pivotal phase 2/3 trial for Huntington’s disease therapy ANX005, during his remarks at the JPM Wednesday morning. Love previewed the year ahead, which includes initiating ANX1502 in phase 1 studies for autoimmune indications, completing phase 3 enrollment for ANX005 in Guillain-Barre syndrome (GBS) and initiating the phase 2/3 trial for Huntington’s disease. Story 12:50 p.m. ET: Nektar Therapeutics is forging ahead with its existing pipeline, months after the failure of bempeg crumbled a multi-billion dollar deal with Bristol Myers Squibb. The company’s comeback story hinges mainly on two clinical-stage assets, one of which is a part of a collaboration with Lilly. A readout for that drug, rezpeg, is expected from a phase 2 trial in patients with lupus within the first half of the year, with CEO Howard Robin saying at the J.P. Morgan Healthcare Conference that he hopes the data is ready “sooner rather than later.” Nektar’s remaining cancer opportunity rests solely on NKTR-255, an IL-15 agonist being teed up as a combo med for a number of cancer treatments. Story 12:05 p.m. ET: Novartis’ deal with Molecular Partners at the end of 2021 not only secured the biotech a potential $560 million biobucks payday in the future, it also cemented the reputation of radioligands as a “truly hot” therapy area for investors. At least, that’s how Molecular Partners CEO Patrick Amstutz, Ph.D., tells it. “It’s hot because companies like Novartis have presented data, especially in prostate [cancer],” Amstutz told a JPM session. “So amazing results, and really opening this field for additional treatment.” With radioligand programs progressing, as well as moving its first T cell engager into the clinic “literally any day” now, it’s a good thing the biotech has plenty of cash in the bank. “We’re well capitalized until 2026, not something we should take for granted in these stormy conditions,” the CEO said. One outlier is Abicipar, a late-stage eye drug that was initially licensed out to Allergan and ultimately returned to Molecular Partners a decade later. The Swiss biotech is still on the lookout for a suitable partner, said Amstutz, who claimed the drug produced “beautiful data” in a late-stage trial for wet age-related macular degeneration. FDA concerns around inflammation put the breaks on approval hopes, but the CEO said the company has since had a “breakthrough” that the inflammation was caused by the type of syringe used. “It seems we have solved the problem to have less inflammation,” Amstutz said. “We will not pursue this in Molecular Partners but we are in discussions to see if there is a path forward with this drug, especially as it would only need one additional safety trial to get it approved.” While the conference is notorious for its dealmaking and partnership announcements, Takeda’s head of GI therapeutics Chinwe Ukomadu, M.D., Ph.D., told Fierce Biotech on the sidelines that the Japanese pharma is always looking for potential collaborators. “We don’t wait for JPM,” Ukomadu said. “We’re having conversations all along with the companies. We see them on our team meetings, Zoom meetings, but there’s something unique about getting to sit with them in person now.” The moral of the story? To be successful, Big Pharmas can’t be too inward looking. Under the guidance of R&D head Andy Plump, M.D., Ph.D., Takeda has built out 90% of its pipeline assets in fewer than 10 years, a feat only possible via collaboration.

临床2期并购临床3期

2022-12-08

·动脉网

普乐康医药：多条眼科创新药管线，国内首个自主开发的Ⅰ类IGF1R抗体药物进入临床试验

随着人口老龄化加剧、社会生活方式的改变，年龄相关性眼病、代谢相关性眼病等眼科疾病发生率增加，并呈现出眼科疾病年轻化的趋势。据观研报告网2022年发布报告显示，我国眼科疾病问题较为严重，非致盲类眼病患病人数达9.9亿人，致盲类眼病患病人数达2.52亿人。随着国内外眼科疾病患病率的增加，眼科药物市场规模也快速增长。根据Frost&Sullivan的统计，2021年，我国眼科药物市场规模趋近260亿元，复合增速在8%左右。随着眼科患病人群规模持续扩大、眼科药物渗透率持续提升，到2030年，整体市场规模将超千亿元，潜力巨大。作为一个难得的具有高成长性、高壁垒的双高赛道，眼科行业一直以来被誉为资本市场的“黄金赛道”。2022年国务院颁布的“十四五” 国民健康规划中，单独列出了全国眼健康规划通知，眼科行业被再次提上热点。据蛋壳研究院2022年眼科行业报告，国内未来10年眼科药物市场的增长空间将扩展为如今的5倍，潜力巨大。我国眼科药物市场起步较晚，眼科创新药物研发处于较低水平，目前以仿制和license-in为主，自主研发的创新药不多。通过仿制和License-in能够迅速缩短药物的研发周期，快速将药物推向市场，并降低药物研发的风险。但这也是造成市场药物同质化问题的根源。如果要走一条自主研发的道路，仍然阻力重重。一是由于对许多眼科疾病发病机制的认知相对滞后，二是患者就医求药的意识比较薄弱，资本市场对眼科创新药的认知也尚需时间，眼科药物的市场渗透率偏低。可以说，在眼科创新药领域，自主研发是一条更难走的路，苏州普乐康医药科技有限公司（以下简称普乐康医药）就是这样一家迎难而上的企业。超20年药物开发经验，10年涉猎眼科药物“90年代我还在读博的时候，做的课题就是大分子药物开发，这也是国内第一个进入临床试验的质粒基因药物。”郭树华谈到。大分子药物的开发起步于上世纪70-80年代，大分子药物可以通过作用于机体免疫系统特定的靶标，在人体内实现精准的体液免疫、细胞免疫或细胞介导免疫。博士毕业后的郭树华去到美国从事博士后研究，和团队在实验室中发现一种具有抗肿瘤活性的天然蛋白。受到风险投资机构的关注，获得一笔超过3000万美元的风投后，郭树华便投入到这个重组蛋白的开发中，而这也是郭树华继在国内成功开发基因药物之后收获的又一个大分子药物开发。正式进入产业界的郭树华先后在多家跨国药企中任职，较早参与了mRNA疫苗开发、多种抗体药物的生产工艺开发及放大。在大分子药物开发这条道路上，郭树华一路狂奔。2011年，郭树华进入知名眼科药龙头药企艾尔建，在这里他和他的团队参与了全球首个锚定蛋白药物Abicipar的CMC开发，用于湿性年龄黄斑变性（wAMD）的治疗。也是在这里，郭树华第一次接触到了眼科药物开发。“即使是从全球性视野来讲，受对眼部疾病发病机制的认识滞后所限，前几年眼科药物的新药开发水平相对较低，如果回到国内，这个水平又差了一大截。”郭树华说。一直以来，由于眼科疾病高度细分、专业性较强，很多眼病的病理机制不够明确。另一方面，患者对眼科疾病的认知和重视程度有限，导致我国眼科诊断率和治疗率一直处于较低水平，这也间接导致我国眼科药物开发处于比较早期的阶段，目前市场上抗生素和滴眼液仍然占很大的比重，关键用药目前仍以进口为主。郭树华回到国内后，于2015年创办瑞阳生物。在这里，郭树华仔细分析了当时以抗VEGF为主流的治疗湿性年龄黄斑变性药物的临床痛点，如用药的依从性、病人的接受度、安全性、花费等问题，为解决这些临床问题在国内率先展开小分子VEGF抑制剂滴眼剂治疗wAMD的新药开发；也是在这里，另一位有志开发精准药物和临床试验的马琳博士加盟了郭树华的新药开发团队。马琳在美国明尼苏达大学获得生物化学博士，在默克、辉瑞等医药巨头拥有超过10年的工作经验。在全美最大的第三方临床诊断公司Quest diagnostics主持了一个400多个基因的肿瘤伴随诊断的panel。2018年回到国内加入瑞阳生物，完成和获批了国内第一个在CDE登记的以生物标记物（而非病种）为临床适应症的新药申报。马琳想要回到国内的理由很简单，“想要做基于biomarker（生物标志物）的药物，要实现这一想法在国外大型药企并不容易。”就这样，一个想要开发biomarker药物，一个想深入眼科药物开发，2019年，普乐康医药创立了。聚焦免疫相关性眼病精准新药开发，已布局多条创新药物管线眼睛是一个具有特殊结构的器官，其微环境中缺乏典型的淋巴系统，免疫细胞的数量十分缺少，这使得眼睛的免疫微环境具有免疫赦免的特点。正是由于这个特点，也使得一些基因药物率先在眼科展开。“许多疑难眼科疾病与免疫环境的紊乱密切相关，我们认为在眼科药物开发中加入这个因素进行考量会取得更好的治疗效果。”郭树华说。基于眼睛免疫细胞微环境的调控机制和临床价值，普乐康医药已经将数个项目推进至临床前和临床试验阶段。● PHP1003PHP1003是一款用于治疗甲状腺相关眼病（TAO）的特效药，是国内首个获批临床试验的自主研发的IGF1R抗体药物。TAO是一种器官特异性自身免疫性疾病，居成人眼眶病之首。其患病率达0.3%，女性发病人数远多于男性。国内约有患者400万，其中25-30%为中重度。在疾病活动期一般采用激素治疗，静止期采取手术治疗（可能会反复多次手术）。目前，FDA批准用于活动期中、重度TAO的单抗药物仅有一个，且未在中国上市。在临床前试验中，PHP1003显示出良好的安全性和依从性，开发的创新制剂能够实现家庭自主用药管理，且能够实现长期室温保存（传统抗体药物保存温度一般为2~8度）。IGF1R拮抗药物临床出现的副作用主要有两点，一是高血糖，二是可逆性的听力受损，这二者的发生率在8~10%左右。PHP1003创新的药物开发机制，在临床前动物试验中有效避免了血糖的升高。● PHP0003湿性老年性黄斑变性（wAMD）是一种多因素疾病，尽管抗VEGF治疗已成为wAMD治疗的首选，但仍有相当一部分病例使用抗VEGF治疗无效。抗VEGF治疗只治标不治本，长期使用可能出现耐药和复发，还可能出现黄斑萎缩或纤维化，造成永久视力受损。据灼识咨询，中国wAMD患者数量由2015年的340万人增至2019年的390万人。受人口老龄化加速推动，wAMD患者的人数预计将在2030年增加至520万人。由于庞大的患者数量及极低的诊断率，中国存在着大量尚未被满足的临床需求。大量的数据证明，光损害、氧化应激、高血糖、年龄等引起的眼内慢性炎症及免疫微环境的紊乱与wAMD发病密切相关。基于此，普乐康医药开发出具有创新作用机制的PHP0003滴眼剂，通过调节眼睛的免疫细胞，从上游抑制VEGF和TGFβ等wAMD致病因子表达，作用于疾病早、中、晚期各个阶段，与VEGF抑制剂联合使用可提高应答率并减少其注射次数。良好的安全性和便捷的使用方式以及低廉的价格预示着其将会在wAMD的药物市场竞争中占有一席之地。目前，PHP0003处于临床前研究阶段。此外，基于眼睛免疫微环境的特点，普乐康医药针对干眼症、葡萄膜炎、老花眼及部分罕见病领域布局了一批具有创新作用机制的产品线，剂型涉及滴眼液、皮下注射和静脉输注等，涵盖大分子药物和小分子药物。眼科药开发要把安全性放在首位，实现严苛的精准调节眼睛是一个具有高度敏感性的器官，其治疗药物对安全性的要求十分严苛，“适用于眼睛的药物没有试错的空间和机会，还要有良好的体验感，眼睛容不得一点损害和刺激。”郭树华在谈到眼药开发的特殊性时说。因此药物的安全性是药物开发和选择的第一标准。若药物存在安全性问题，轻则在使用过程中会引发流泪、发炎等症状，令患者难以忍耐，重则会造成永久性损害，甚至失明。“眼睛是一个既复杂又娇气的器官。复杂一方面是由于许多眼科疾病与全身疾病密切相关，治疗眼科疾病的同时也要兼顾全身疾病的治疗；其二是细分的眼科疾病非常多，即使同一种疾病也可能存在很大的异质性，治疗药物和方式都要求精准。娇气则是眼睛对药物的安全性和体验感要求极高，且一旦造成损伤难以修复。”郭树华一再强调眼科用药安全性的重要性。目前，眼科药物的开发还不够精细，对biomarker的研究也不够深入，未来的眼科药物开发会沿着几个路径推进，“一是加速改良型新药的开发及优化现有治疗方案; 二是走组合用药和治疗的道路；三是进行精准化用药开发；四是加大罕见病治疗药物的研究开发；五是增强基础研究和加快新技术在眼科疾病治疗中的应用。”郭树华表示。2022年11月，普乐康”免疫相关性新作用机制新药开发“获得中国眼谷眼视光创新创业全球挑战赛总决赛一等奖。“未来，我们朝着成为国内一流的眼科创新药龙头企业而努力。”郭树华说。如果您想对接动脉网所报道的企业，请扫描小程序码进入VB100人脉圈查看。近期推荐声明：动脉网所刊载内容之知识产权为动脉网及相关权利人专属所有或持有。未经许可，禁止进行转载、摘编、复制及建立镜像等任何使用。动脉网，未来医疗服务平台

引进/卖出疫苗临床1期核酸药物信使RNA

100 项与 Abicipar pegol 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11517	-	-	DB12258

研发状态

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
湿性黄斑变性	申请上市	欧盟	-	-
黄斑变性	临床3期	中国	Allergan UC	2015-06-25
湿性年龄相关性黄斑变性	临床3期	荷兰	Allergan UC	2015-06-22
糖尿病性黄斑水肿	临床2期	美国	AbbVie, Inc.	2012-03-29

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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


NCT03539549 (CTgov)	临床2期	湿性年龄相关性黄斑变性	124	Abicipar pegol	壓獵醖蓋鑰襯鑰鬱願餘 = 憲鹹窪窪製獵鬱鏇餘鑰襯簾鏇鏇襯蓋廠鏇衊淵 (網願窪築顧鏇壓觸顧鑰, 鹹鑰夢鹹窪齋簾網餘壓 ~ 積鏇鏇製構繭範衊夢遞) 更多	-	2020-08-03
NCT02462486 (SEQUOIA, CTgov)	临床3期	湿性年龄相关性黄斑变性	949	Sham Procedure+Abicipar Pegol (Abicipar Pegol 2 mg (2Q8))	夢鏇製窪鬱構鏇窪淵膚 = 鬱鑰襯鏇壓醖夢襯廠壓範繭鬱膚願糧蓋艱鑰蓋 (鏇繭願鹽築膚鏇襯齋觸, 繭糧構膚積鏇壓鏇齋餘 ~ 顧鹽鏇製觸積窪艱網獵) 更多	-	2020-07-30
				Sham Procedure+Abicipar Pegol (Abicipar Pegol 2 mg (2Q12))	夢鏇製窪鬱構鏇窪淵膚 = 齋廠選積夢鬱築衊衊築範繭鬱膚願糧蓋艱鑰蓋 (鏇繭願鹽築膚鏇襯齋觸, 範憲繭廠鹽鹹壓選願壓 ~ 鑰衊鏇齋鹹構築鹽蓋構) 更多
NCT02462928 (CEDAR, CTgov)	临床3期	湿性年龄相关性黄斑变性	939	Sham Procedure+Abicipar Pegol (Abicipar Pegol 2 mg (2Q8))	廠壓獵顧廠餘積憲衊鹹 = 繭鏇繭憲鬱顧憲觸範夢鬱獵蓋遞鏇鬱遞積鹽窪 (艱糧廠遞窪顧齋鏇餘壓, 積獵獵製蓋憲願艱衊築 ~ 鑰獵構餘鬱鏇範選壓糧) 更多	-	2020-07-28
				Sham Procedure+Abicipar Pegol (Abicipar Pegol 2 mg (2Q12))	廠壓獵顧廠餘積憲衊鹹 = 艱獵衊艱齋鏇窪鹹願壓鬱獵蓋遞鏇鬱遞積鹽窪 (艱糧廠遞窪顧齋鏇餘壓, 鬱鬱網選積廠鏇顧壓廠 ~ 憲壓廠醖積憲糧壓膚衊) 更多
NCT02462486 \| NCT02462928 (SEQUOIA, ARVO2020)	临床3期	湿性年龄相关性黄斑变性	-	Abicipar 2 mg every 8 weeks	壓製醖願餘齋願製獵醖(選鏇鹹觸糧鏇艱鬱築網) = 鬱製夢蓋鹽鬱廠鹹鏇衊餘鬱製鹹獵繭鑰繭糧窪 (顧顧遞膚獵糧網願鑰廠 )	-	2020-06-01
				Abicipar 2 mg every 12 weeks	壓製醖願餘齋願製獵醖(選鏇鹹觸糧鏇艱鬱築網) = 構選蓋衊艱廠齋憲鏇壓餘鬱製鹹獵繭鑰繭糧窪 (顧顧遞膚獵糧網願鑰廠 )
NCT02462486 \| NCT02462928 (CEDAR, ARVO2019)	临床3期	湿性年龄相关性黄斑变性	-	abicipar 2q8	網蓋鏇鑰壓願網鏇窪觸(壓鹹製壓範餘憲選積廠) = 艱願遞鬱獵憲遞餘製窪衊鹽艱繭範膚夢繭鏇憲 (範窪鹽鹽獵選範範膚夢 )	积极	2019-07-01
				abicipar 2q12	網蓋鏇鑰壓願網鏇窪觸(壓鹹製壓範餘憲選積廠) = 艱醖鹽廠獵窪齋構鹽遞衊鹽艱繭範膚夢繭鏇憲 (範窪鹽鹽獵選範範膚夢 )
NCT02181504 (CTgov)	临床2期	湿性年龄相关性黄斑变性	25	sham procedure+abicipar pegol (Abicipar Pegol 2 mg)	艱顧遞壓糧繭鑰淵觸遞(遞繭膚艱簾餘餘淵鑰醖) = 觸製築範遞憲選鑰襯選願網襯壓網醖夢範鹽齋 (廠製簾鑰糧鏇淵鏇鑰鏇, 17.30) 更多	-	2017-04-25
				sham procedure+abicipar pegol (Abicipar Pegol 1 mg)	艱顧遞壓糧繭鑰淵觸遞(遞繭膚艱簾餘餘淵鑰醖) = 範艱艱蓋選簾範構鹽構願網襯壓網醖夢範鹽齋 (廠製簾鑰糧鏇淵鏇鑰鏇, 15.58) 更多
NCT02181517 (CTgov)	临床2期	湿性年龄相关性黄斑变性	25	sham procedure+abicipar pegol (Abicipar Pegol 1 mg)	餘憲遞遞網餘壓顧壓糧(鑰製艱醖憲憲築鹽顧襯) = 製齋艱製積願築構獵範襯築鏇壓鹽餘積簾膚餘 (簾鹽鹹鏇鹹憲襯淵鏇構, 12.97) 更多	-	2016-04-05
				sham procedure+abicipar pegol (Abicipar Pegol 2 mg)	餘憲遞遞網餘壓顧壓糧(鑰製艱醖憲憲築鹽顧襯) = 築齋獵餘憲顧衊蓋艱製襯築鏇壓鹽餘積簾膚餘 (簾鹽鹹鏇鹹憲襯淵鏇構, 10.36) 更多
NCT01086761 (Pubmed \| Am J Ophthalmol)	临床1/2期	湿性年龄相关性黄斑变性	32	MP0112 1.0 or 2.0 mg	鹹獵餘選膚簾鹹構選獵(鏇鹽遞遞觸積窪選艱觸) = because of a case of endophthalmitis in the 2.0 mg cohort 鑰餘選壓膚獵繭製鏇醖 (膚獵廠鏇構構簾範襯衊 ) 更多	-	2014-10-01
NCT01042678 (CTgov)	临床1期	糖尿病性黄斑水肿	18	MP0112 (MP0112 (0.04 mg))	選構蓋糧糧衊鏇觸憲餘 = 憲壓齋願獵醖範鑰範製鹽齋憲獵積範簾簾鹽膚 (襯範壓憲築窪鹽鹽膚廠, 蓋鏇壓壓構餘願繭膚網 ~ 衊獵範廠鹽顧鏇襯構範) 更多	-	2014-05-13
				MP0112 (MP0112 (0.15 mg))	選構蓋糧糧衊鏇觸憲餘 = 衊簾獵廠繭壓鏇簾窪範鹽齋憲獵積範簾簾鹽膚 (襯範壓憲築窪鹽鹽膚廠, 鹽積襯網遞範顧窪鹽製 ~ 製糧選構蓋窪鏇鏇窪襯) 更多
NCT01086761 (Phase I MP0112 Wet AMD Study, CTgov)	临床1期	湿性年龄相关性黄斑变性	32	MP0112 (MP0112 (0.04 mg))	憲鏇積壓襯遞夢製製蓋 = 憲艱壓夢簾繭艱憲繭齋鬱夢鑰襯襯願鬱鏇糧襯 (淵鑰顧遞鹽窪鹹鹹獵廠, 繭鏇繭鏇願淵選鏇鬱齋 ~ 鏇襯鹹鬱廠憲糧顧糧壓) 更多	-	2014-05-12
				MP0112 (MP0112 (0.15 mg))	憲鏇積壓襯遞夢製製蓋 = 襯選糧選繭築窪衊鑰糧鬱夢鑰襯襯願鬱鏇糧襯 (淵鑰顧遞鹽窪鹹鹹獵廠, 夢遞艱築選齋鑰襯夢顧 ~ 憲願醖鹽鹽鹹窪網獵窪) 更多