This study is investigating the use of episcleral brachytherapy (ESB) adjunct to aflibercept compared to aflibercept monotherapy for the treatment of polyploid choroidal vasculopathy (PCV) in patients experiencing an inadequate response to anti-VEGF monotherapy.

开始日期2025-03-01

申办/合作机构

Salutaris Medical Devices, Inc.

NCT06398080 / WithdrawnN/A

Real-World Patient Characteristics, Treatment Patterns, and Outcomes Among Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) Treated With Aflibercept 8 mg in the United States

The purpose of this research study is to observe the patient's clinical care and how EYLEA® HD is used as a treatment in real-world settings. Patients are asked to join the study because they have either neovascular age-related macular degeneration (nAMD/wet age-related macular degeneration [AMD]) or diabetic macular edema (DME). Patients cannot have used EYLEA® HD in the past and the doctor must be planning to treat nAMD or DME with a new prescription of EYLEA® HD (aflibercept 8 mg).

开始日期2024-12-12

申办/合作机构

Regeneron Pharmaceuticals, Inc.

NCT06662994 / Not yet recruiting临床4期IIT

High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy

Patients with diabetic macular edema (DME) sometimes must undergo vitrectomy surgery (PPV) for diabetic and non-diabetic related issues. Patients may have improved DME with anti-VEGF therapy and ranibizumab has been found to reduce central macular thickness (CMT) with anti-VEGF therapy following vitrectomy. Those patients still require intravitreal injections but the pharmacokinetics of a vitrectomized eye are different than those eyes that have not undergone vitrectomy. The clearance of protein molecules is quicker in vitrectomized eyes so these patients may be more refractory to standard of care anti-VEGF therapy. In rabbit models, the half-life of both bevacizumab and ranibizumab were reduced by a factor 1.8 and 1.3, respectively, after pars plana vitrectomy. In a study examining intravitreal triamcinolone acetonide in human eyes, the half-life was found to be 18.6 days in non-vitrectomized eyes and 3.2 days in vitrectomized eyes, but there was considerable intrasubject variation. Patients with various disease states, including neovascular age-related macular degeneration (nAMD) have been managed with monthly anti-VEGF therapy successfully after vitrectomy surgery. Another study performed by the DRCR net showed that patients with DME treated with anti-VEGF are not affected in the long term if they had had a previous vitrectomy. High dose aflibercept may improve anatomic and visual outcomes in this patient population. Also, high dose aflibercept may allow for longer treatment intervals in these vitrectomized eyes.

开始日期2024-11-15

申办/合作机构

Regeneron Pharmaceuticals, Inc.

100 项与阿柏西普相关的临床结果

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100 项与阿柏西普相关的转化医学

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100 项与阿柏西普相关的专利（医药）

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3,358

项与阿柏西普相关的文献（医药）

2025-02-01·Photodiagnosis and Photodynamic Therapy

Comparison of one-year real-world outcomes between red (670 nm) subthreshold micropulse laser treatment and intravitreal aflibercept injection for treatment-naïve diabetic macular edema

Article

作者: Kikushima, Wataru ; Kashiwagi, Kenji ; Furuhata, Yukiko ; Viel Tsuru, Daphne ; Sakurada, Yoichi ; Matsumoto, Mizuki ; Shijo, Taiyo

PURPOSE:

To evaluate the treatment outcomes of subthreshold micropulse laser (SMPL) with a wavelength of 670 nm (red) for treatment-naïve diabetic macular edema (DME).

METHODS:

A retrospective observational study which included 42 eyes in 34 patients diagnosed with treatment-naïve DME was conducted. Twenty-one eyes underwent red SMPL and the other 21 eyes underwent intravitreal injection of aflibercept (IVA) as initial treatment and were followed up for 12 months. Best-corrected visual acuity (BCVA), central retinal thickness (CRT) on optical coherence tomography (OCT), vessel density (VD), and foveal avascular zone area on OCT angiography (OCTA) were measured and compared between the two groups.

RESULTS:

In the red SMPL group, the mean BCVA slightly improved from 0.29 ± 0.28 at baseline to 0.22 ± 0.29 at 12 months (p = 0.18), while the mean CRT significantly decreased from 472 ± 200 µm at baseline to 320 ± 136 µm at 12 months (p = 0.003). At 12 months from baseline, the mean change in BCVA and CRT were similar between the red SMPL and IVA groups (p = 0.79 and p = 0.31, respectively). No significant change was detected in OCTA parameters except for VD at the nasal section in the red SMPL group.

CONCLUSION:

Red SMPL for treatment-naïve DME maintained BCVA and significantly reduced CRT at 12 months. These treatment outcomes were equivalent to IVA in real-world settings, which tend to be inferior to clinical trials.

2025-02-01·AMERICAN JOURNAL OF OPHTHALMOLOGY

Submacular Hemorrhage Rates Following Anti-Vascular Endothelial Growth Factor Injections for Exudative Age-Related Macular Degeneration

Article

作者: Kaufmann, Gabriel T. ; Boucher, Nicholas ; Kaufmann, Gabriel T ; Starr, Matthew R. ; Aggarwal, Nitika ; Starr, Matthew R ; Sharma, Chakshu

PURPOSE:

To examine rates of submacular hemorrhage in patients undergoing anti-vascular endothelial growth factor (VEGF) injections, comparing rates between specific anti-VEGF agents.

DESIGN:

Retrospective clinical cohort study.

METHODS:

All patients in the database from January 2015 to November 2023 with a diagnosis of neovascular age-related macular degeneration and accompanying submacular hemorrhage (SMH). SMH prevalence and associated anti-VEGF injection type were analyzed in 140,915 eyes (of which 9107 had SMH) in a nationwide aggregated electronic health care database using chi-square test of proportion. Visual acuity (VA) data was assessed using 2-sample independent t-tests. The primary outcome was rate of SMH per injection type. Secondary datapoints examined were time between SMH diagnosis and last anti-VEGF injection, number of injections before SMH, treatment interval at time of SMH, VA before and at 12 months after SMH, eyes undergoing pars plana vitrectomy (PPV) within 30 days of SMH, and VA before PPV and at 12 months after PPV.

RESULTS:

The last injection type in eyes with SMH was bevacizumab in 3430 (37.8%) eyes, brolucizumab-dbll in 46 (0.51%) eyes, aflibercept in 3221 (35.4%) eyes. Ranibizumab in 2246 (24.7%) eyes, and faricimab-svoa in 155 (1.7%) eyes. Rates of SMH were significantly higher (P ≤ .001) for last injection with bevacizumab compared to every other injection type. Rates of SMH were significantly lower (P = .0004) for last injection with faricimab-svoa or ranibizumab injections each had significantly shorter (mean and standard deviation 48.9 (27.9), P < .02; mean and standard deviation 59.6 (38.2), P = .003, respectively) mean time between SMH diagnosis and last injection than did patients undergoing any other injection. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type among all patients. The number of patients who underwent PPV were 52 (1.51%) for bevacizumab, 4 (8.7%) for brolucizumab-dbll, 58 (1.8%) for aflibercept, 41 (1.8%) for ranibizumab, and 3 (1.9%) for faricimab-svoa. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type in patients undergoing PPV.

CONCLUSIONS:

Faricimab may be more protective than other anti-VEGF injections against SMH in patients with neovascular age-related macular degeneration.

2025-01-01·SURVEY OF OPHTHALMOLOGY

Evidence-based guidelines for drug dosing in intravitreal injections in silicone oil-filled eyes: Pharmacokinetics, safety, and optimal dosage

Review

作者: Loewenstein, Anat ; Zinkernagel, Martin ; Henderson, Robert ; Melo, Gustavo Barreto ; Chhablani, Jay ; Roth, Janice ; Bernardi, Enrico ; Fung, Adrian T ; Wykoff, Charles C ; Chou, Hung-Da ; Querques, Giuseppe ; Cheung, Chui Ming Gemmy ; Tsui, Edmund ; Wu, Xia Ni ; Sim, Peng Yong ; Subhi, Yousif ; Anguita, Rodrigo ; Wykoff, Charles C. ; Paschon, Karin ; Ferro Desideri, Lorenzo ; Kiilgaard, Jens Folke ; Melo, Gustavo ; Berrocal, Maria ; Desideri, Lorenzo Ferro

We evaluate the pharmacokinetics, safety, and optimal dosages of intravitreal agents in silicone oil (SO)-filled eyes, addressing challenges in administering such therapies. We assessed the pharmacological properties and safety profiles of intravitreal drugs in SO-filled eyes, deriving conclusions and guidance from available literature and expert consensus. Preclinical data suggest comparable half-lives of anti-vascular endothelial growth factoragents in SO-filled eyes, but clinical evidence is mainly from case reports and small series. Available research prioritizes standard dosages, particularly for bevacizumab (1.25 mg), supported by stronger evidence than aflibercept (2 mg) or ranibizumab (0.5 mg). Intravitreal steroids, especially dexamethasone at 0.7 mg, show efficacy and safety, while evidence for fluocinolone acetonide at 0.19 mg is limited. Intravitreal methotrexate has been reported at the dosage of 250-400 μg, with keratitis as the primary expected side effect. Case reports indicate tolerability of standard dosages of antivirals (foscarnet 1.2-2.4 mg/0.1 mL, ganciclovir 4 mg/0.1 mL) and the antibiotic combination piperacillin/tazobactam (250 μg/0.1 mL). We offer guidance based on current, but limited, literature. Standard dosage of intravitreal agents should be carefully considered, along with close monitoring for potential side effects, which should be discussed with patients.

1,079

项与阿柏西普相关的新闻（医药）

2024-12-13

·Pharmaceutical Technology

Roche wins Vabysmo prefilled syringe EU approval to intensify Eylea challenge

Roche’s blockbuster Vabysmo is vying for ophthalmological dominance against Regeneron’s Eylea. Image credit: Shutterstock / Marlon Trottmann. The European Medicines Agency (EMA) has approved Roche’s Vabysmo (faricimab) in single-dose prefilled syringe form for three retinal conditions that cause blindness. Roche’s ready-to-use drug is indicated for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular oedema (DME) and macular oedema following retinal vein occlusion (RVO), as per a 13 December press release. Shares in Roche opened 0.5% down at market open on 13 December, likely due to the separate event of Saratoga Research & Investment Management decreasing its position in the pharma company yesterday by 3.5%. The Swiss drugmaker has a market cap of $203.1bn. Blockbuster Vabysmo has already been available in Europe for the same three diseases in 6.0mg Vabysmo vials. The drug received its most recent approval in July this year when RVO was added to its EU label. Both the prefilled syringe and vials deliver faricimab, a bispecific antibody that blocks vascular endothelial growth factor-A (VEGF-A) and angiopoietin-2 (Ang-2). Blocking these two protein pathways stabilises blood vessels and prevents fluid leakage, the latter being the cause of vision loss in patients with the conditions. Together, nAMD, DME and RVO affect more than nine million people in the EU, according to Roche. AMD is the leading cause of vision loss in people over 50 years of age. A 2022 report by nonprofit Retina International estimated the economic burden of late-stage AMD in Germany was €7.6bn. Regeneron Pharmaceuticals ’ Eylea (aflibercept) currently dominates the ophthalmologic market in Europe. Similar to Vabysmo, it is also available in both vials and prefilled syringes, and administered via intravitreal injection. Eylea, along with a higher-dose version at 8mg, generated global sales of $9.38bn – down 3% from 2022. Vabysmo’s sales, meanwhile, grew 324% to bring in $2.64bn. Eylea took another hit in October when Regeneron lost an attempt to block the launch of a biosimilar developed by Pavblu. The US Food and Drug Administration (FDA) has already approved multiple aflibercept biosimilars this year. GlobalData’s Pharma Intelligence Centre predicts a continued decrease in sales over the next five years for Eylea amid increased competition from Vabysmo and biosimilars. By 2030, Roche’s candidate is forecast to reach global sales of $8.78bn, whilst Eylea stutters to $2bn. Roche’s chief medical officer Levi Garraway said: “Approval of the Vabysmo prefilled syringe in the EU offers a convenient way for ophthalmologists to administer this treatment for people with three of the most common causes of vision loss.” “This simplified administration may thereby help reduce the treatment burden for patients and retina specialists.”

上市批准生物类似药

2024-12-02

·国际糖尿病idiabetes

王红教授：浅谈糖尿病黄斑水肿中Müller细胞的作用

第12届PCV论坛扫描二维码可查看更多内容编者按糖尿病视网膜病变（DR）是糖尿病患者主要的眼部并发症，而在DR的进展中，糖尿病黄斑水肿（DME）是患者视力下降的主要原因。Müller细胞是哺乳动物视网膜中主要的神经胶质细胞之一，在维持内环境稳态和神经元结构完整性、稳定性以及信号转导等方面具有重要作用。人类视网膜中的Müller细胞是直接参与DME发病过程的关键结构之一。在2024年海峡两岸医药卫生交流协会眼科学专委会第十二届PCV论坛暨黄斑病年会上，山东大学齐鲁医院的王红教授基于研究数据和自身丰富的临床经验，就“DME中Müller细胞的作用”这一话题进行了详细阐述，为眼科医师更好地治疗DME拓宽了诊疗思路。 1 DME积液平稳控制的重要性 2018年以后，眼科医师越来越关注DME积液的吸收，抗血管内皮生长因子（VEGF）药物在DME积液吸收中大显身手，如何尽早、尽量、稳定地将DME积液控制在可控范围内，是眼科医师一直关注的重要课题。 ■ 尽早消除积液可快速改善患者的视力： Protocol T事后分析显示[1]，中心凹1mm的视网膜内液（IRF）每降低10nl，最佳矫正视力（BCVA）平均提高0.15个字母数；中心凹1mm的视网膜下液（SRF）每降低10nl，BCVA平均提高0.34个字母数（图1）；图1. 中心凹1mm内积液每减少10nl，BCVA的变化情况 ■ 尽早消除积液有利于恢复椭圆体带（IS/OS）的完整性：一项回顾性研究显示[2]，DME消退后，DME持续时间较短的患者更有可能拥有完整（恢复）的IS/OS（图2）；图2. IS/OS始终破坏组，DME持续时间更长 ■ 尽量消除积液，可改善患者的视力预后：一项真实世界研究显示[3]，积液完全消退患者，第1年视力改善比积液残余患者多12个字母（图3）；图3. 积液完全消退患者，第1年视力改善比积液残余患者多12个字母 ■ 黄斑中心凹厚度（CST）平稳，控制患者2年视力获益高2.35个字母： Protocol V事后分析显示[4]，CST的大幅波动预示着DME患者在2年终点时的视力结局更差（图4）。图4. CST的大幅波动预示着DME患者在2年终点时的视力结局更差尽管眼科医师已经非常重视DME积液的吸收，但是真实世界临床研究发现，仍有相当一部分患者存在治疗不足的情况，抗VEGF单药无法完全解决水肿问题。在水肿消退不彻底、残余水肿持续存在的情况下，患者的外层视网膜会遭到严重破坏，进而导致患者的视力出现不可逆性损伤。由此也引发一个思考，除了血-视网膜屏障破坏、血管内皮细胞紧密连接破坏以外，可能还有其他因素参与DME积液形成，造成水肿波动。 2 Müller细胞受损与DME积液 DME的实质是血管渗漏导致的黄斑积液（图5），分为IRF和SRF。IRF除了与血-视网膜屏障有直接关系以外，与Müller细胞的引流功能也存在密切联系，Müller细胞的引流功能出现障碍后就会导致积液出现，因此眼科医师对于IRF的关注度提升之后，也会引入对Müller细胞的关注。IRF除了会造成视力下降，造成光传输衍射或受阻，还会造成神经感觉层光传输障碍，并造成双极细胞或光感受器细胞的轴突出现拉伸变化，阻止光感受器向神经节细胞的信号传递。1999年，DME被分型为海绵状弥漫性视网膜增厚（DRT/SDRT）、黄斑囊样水肿（CME）和浆液性视网膜脱离（SRD）。CME中包含许多与Müller细胞相关的生物标志物，例如DRIL、桥状连接、视网膜囊内高反射物质（ICHRM）等。图5. DME的实质是血管渗漏导致的黄斑积液王红教授随即分享了一位长达9年应用抗VEGF治疗的DME患者的治疗过程（图6、图7），该患者于2015年~2024年持续治疗，总计给予抗VEGF治疗34针（雷珠单抗、康柏西普、阿柏西普）。在治疗过程中，IRF起起伏伏，不停复发，但是随着规范治疗进程的推进，患者的水肿囊腔慢慢消退，并呈现出不同的表现，除了形态、直径大小有变化以外，水肿囊腔内容物有清亮液体、高反射物质和高反射点（图8），这种情况与Müller细胞密切相关。图6. 患者基本情况图7. 患者初诊时眼底检查图8. 患者不同时期水肿囊腔的不同表现 1851年，德国解剖学家Heinrich Müller在视网膜上发现了一种新的大胶质细胞——Müller细胞。每个Müller细胞与一个视锥细胞、大约十个视杆细胞以及几个视网膜内神经元相连，这些神经元被称为视网膜神经元的柱状微孔，是视觉“前向信息处理”所需的最小功能单元。Müller细胞的主要功能是调节细胞膜内外离子和水的平衡、调节代谢、恢复神经递质和抗氧化。在无明显血管造影血管渗漏的情况下，Müller细胞肿胀也会导致CME的发展。非人类灵长类动物黄斑组织学切片可见，当IRF和SRF存在时，会直接造成Müller细胞的形态发生异常。胶质反应性是DR的早期特征。高血糖早期，三种神经胶质细胞的反应性表现为Müller细胞增生、星形胶质细胞密度降低和小胶质细胞活化。胶质反应性变化早于血-视网膜屏障的破坏，高血糖刺激会造成Müller细胞的细胞膜中钠钾ATP酶异常，以及VEGF和Kir4.1表达异常，最终造成细胞内水肿（图9）。胶质纤维酸性蛋白（GFAP）是一种常见于星形胶质细胞中的蛋白质，Müller细胞中GFAP的表达被认为是视网膜损伤的标志物。在糖尿病大鼠动物模型中[5]，可见Müller细胞中GFAP的表达明显增加（图10）。图9. Müller细胞中VEGF和Kir4.1表达异常的发生机制图10. 糖尿病大鼠动物模型可见Müller细胞中GFAP的表达明显增加临床中也有很多和Müller细胞相关的生物标志物： ■ DRIL：其与Müller细胞和GFAP水平的降低存在相关性。研究可见，基线时存在大片DRIL，是累及中心凹的DME（CI-DME）视力下降的预测因子（图11）。当DRIL出现面积和直径增加时，往往提示患者的Müller细胞已经出现严重的损害，患者抗VEGF治疗的视力预后较差[6-7]；图11. DRIL是CI-DME视力的预测因子 ■ Müller细胞锥： Müller细胞锥是Gass提出的概念，认为黄斑中心凹存在2种类型的Müller细胞：中心凹的Müller细胞、“Z型”的位于中心凹壁的Müller细胞，中心凹的Müller细胞也称Müller细胞锥。三位DME患者的OCT图像可见（图12），左图中心凹Müller细胞锥完整（黄色星号）；中图严重DME患者的旁中心凹Z型结构变垂直，难以分辨Henle’s 纤维层和外核层；右图中心凹Müller细胞锥完全破坏（红色箭头）。Müller细胞锥的存在往往提示患者Müller细胞的功能尚可，当Müller细胞锥严重损坏以后，会影响Müller细胞的液体吸收功能以及外丛状层中光感受器的突触形成能力，导致抗VEGF治疗后较差的视力及CST应答；图12. 三位DME患者中心凹Müller细胞锥图像 ■ ICHRM： ICHRM是DME患者OCT上视网膜内囊腔存在的高反射物质团（图13），且区隔于高反射点或硬性渗出，一般在DME发生7个月后出现，是DME眼OCT的另一项发现，有可能成为一种预测DME预后的新生物标志物，存在ICHRM预示视力结局不佳[8]。在DME患者眼OCT上ICHRM非常多的情况下，可以考虑在基线时联合激素治疗。图13. ICHRM的OCT特征小结：王红教授最后总结道，DME的实质为黄斑积液，积液存在会影响视网膜组织/结构，导致视力损伤。持久、平稳控制积液可带来更大视力获益，积液完全消退，视力预后更佳。胶质细胞和炎症因子在DME的发生发展中发挥了重要作用，眼科医师关注Müller细胞和胶质反应性，有助于平稳控制DME，希望未来有更多数据支持Müller细胞的相关研究。参考文献（上下滑动可查看） [1]Roberts PK, et al. JAMA Ophthalmol. 2020 Sep 1;138(9):945-953. [2]Muftuoglu IK, et al. Eur J Ophthalmol. 2017 Aug 30;27(5):585-590. [3]Penaud B, et al. J Fr Ophtalmol. 2017;40:839-843. [4]Starr MR, et al. Am J Ophthalmol. 2021 Dec;232:90-97. [5]Mat Nor MN, et al. J Anat. 2023;243(4):697-705. [6]Sun JK,et al. JAMA Ophthalmol. 2014 Nov;132(11):1309-16. [7]Sun JK, et al. Diabetes. 2015 Jul;64(7):2560-70. [8]Venkatesh R et al. Intracystic hyperreflective material in centre-involving diabetic macular oedema. Graefes Arch Clin Exp Ophthalmol. 2021 Sep;259(9):2533-2544. 声明：本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。最新《国际糖尿病》读者专属微信交流群建好了，快快加入吧！扫描左边《国际糖尿病》小助手二维码（微信号：guojitnb），回复“国际糖尿病读者”，ta会尽快拉您入群滴！（来源：《国际眼科时讯》编辑部）

申请上市临床研究ASH会议

2024-11-29

·药时代

股价大跌80%！Outlook撞不完的南墙

欢迎参加2024肝病新药联盟年会暨减重新药论坛！麻绳总挑细处断，厄运专找苦命人。 2024年11月27日，Outlook Therapeutics宣布其核心管线ONS-5010（贝伐珠单抗生物类似药），在用于湿性年龄相关性黄斑变性（wAMD）的3期NORSE EIGHT 试验中，未能达到非劣效终点。受此消息影响，Outlook股价暴跌至多81%，最低报0.87美元/股。 ONS-5010是贝伐珠单抗的剂型改良款。后者原研为基因泰克（当时尚未被罗氏收购），2004年首次获批用于转移性结直肠癌，虽批准的是肿瘤适应症，但在上市后不久却出现了超适应症治疗wAMD的案例。 wAMD也称为渗出性AMD或新生血管性AMD（nAMD），影响全球超过1500万人，约占70岁及以上人口的5%。该疾病是60≥岁个体中心视力丧失的主要原因之一。实际上，同年（2004年）Eyetech和辉瑞推出了全球首款抗VEGF眼科药物Macugen，用于治疗wAMD。那为何有“正规药”不用，却选择超适应症用药？原因很简单，贝伐珠单抗的使用价格更为经济实惠。 2006年，FDA批准了基因泰克/诺华的雷珠单抗，用于wAMD。由于该药物在临床疗效上优于Macugen，上市首年便实现了7.1亿美元的销售额。可以说，在2011年之前（再生元的阿柏西普还未上市），雷珠单抗几乎独占眼科抗VEGF药物市场，其巅峰销售额超过43亿美元。按理来说，有了雷珠单抗，应该就无需使用贝伐珠单抗超适应用药了吧？并非如此。截止日前，美国市场上已有的5款wAMD等视网膜疾病抗VEGF疗法的普遍价格在2000美元左右，而重新包装的贝伐珠单抗，一针的价格约为75美元。两者选其一，对于许多经济能力有限的患者而言，价格为王。创新药太难，门槛过高，wAMD市场需求摆在眼前，剂型改良成为机遇。2010年，Outlook成立，公司致力于推动贝伐单抗眼科制剂ONS-5010的商业化，目前该药物已于今年获得了欧盟和英国监管部门的批准。对于Outlook而言，最想吃下的“蛋糕”还是美国市场。因为美国上市药品具有自主定价权，高额的价格差将会给ONS-5010带来不错的市场竞争力。至此，Outlook开启了与FDA之间的鏖战。 2019年4月，Outlook宣布FDA已经批准了ONS-5010用于治疗wAMD、糖尿病性黄斑水肿和分支视网膜静脉阻塞的IND申请； 2022年3月，Outlook向FDA递交上市申请；同年5月，因FDA要求Outlook提供更多补充信息，Outloo自愿撤回了ONS-5010的BLA；同年8月，Outlook收到CRL，FDA指出ONS-5010在分装过程中，存在CMC问题； 2023年11月，Outlook解决了相关的CMC问题，并与FDA进行A类会议。FDA要求增设非劣效性研究，拟定的研究为一项为期3个月的非劣效性研究，需对比ONS-5010与雷珠单抗治疗初治wAMD患者的疗效和安全性。研究的主要终点测量时间点为第2个月。然后，就有了如今NORSE EIGHT试验失败，Outlook仍然宣布计划在2025年第一季度重新提交BLA的“抓马”情节。值得一提的是，在这期间，Outlook的股价一路下跌，未曾止步。 Outlook之所有不愿意放弃，是因为增设的非劣效性研究为期3个月，而此次公布的是数据为两个月的数据。Outlook认为，自己还有机会。 NORSE EIGHT研究结果显示，治疗第8周，在意向性治疗（ITT）人群中，ONS-5010组和雷珠单抗组的BCVA平均值差异不显著（+4.2 vs +6.3个字母，差异为-2.257，95% CI: -4.044, -0.470；P=0.0863），未达到FDA在特殊方案评估（SPA）中预先指定的非劣效性范围下限（-3.5），也未达到P值要求（P>0.025）。 “我们仍然坚信，ONS-5010是治疗湿性AMD的一种重要疗法，可替代未获监管批准用于眼科的贝伐珠单抗非标制剂。”Outlook嘴硬道。 2011年，再生元的阿柏西普强势杀出，凭借其最长可以三个月给药一次的优势，力压雷珠单抗，成就眼科药王。 2022年，罗氏携新一代VEGF双抗Vabysmo“找回场子”。与阿柏西普相比，Vabysmo将治疗周期延长到了每4个月一次，且疗效优异。眼科抗VEGF药物市场早已今非昔比，双抗迭代单抗，药王生物类似药“泛滥”。截至目前，已有五款阿柏西普的生物类似药获得FDA批准，最新批准的为安进在2024年8月获批上市的Pavblu。如此环境下，能与原研药竞争的ONS-5010，能在雷珠单抗生物类似药与阿柏西普生物类似药中，幸存下来吗？封面图来源：pixabay 诺和诺德旗下诺和盈®正式国内上市，掀开中国肥胖防治新篇章 2024-11-28 写在全球肺癌关注月 | “筛、诊、治、管”：中国肺癌患者长生存再进一步 2024-11-27 又一ATTR重磅药上市，辉瑞的劲敌？ 2024-11-26 版权声明/免责声明本文为原创文章。本文仅作信息交流之目的，不提供任何商用、医用、投资用建议。文中图片、视频、字体、音乐等素材或为药时代购买的授权正版作品，或来自微信公共图片库，或取自公司官网/网络，部分素材根据CC0协议使用，版权归拥有者，药时代尽力注明来源。如有任何问题，请与我们联系。衷心感谢! 药时代官方网站:www.drugtimes.cn 联系方式: 电话:13651980212 微信:27674131 邮箱:contact@drugtimes.cn 点击报名参会！

临床申请生物类似药并购

100 项与阿柏西普相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D09574	阿柏西普	L01XX44 S01LA05	DB08885

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
早产儿视网膜病变	日本	Bayer Yakuhin Ltd.	2022-09-26
新生血管性青光眼	日本	Bayer Yakuhin Ltd.	2020-03-25
结直肠癌	日本	Sanofi KK	2017-03-30
糖尿病性视网膜病变	美国	Regeneron Pharmaceuticals, Inc.	2015-03-25
黄斑水肿	日本	Bayer Yakuhin Ltd.	2013-11-22
视网膜静脉阻塞	欧盟	Bayer AG	2012-11-21
视网膜静脉阻塞	冰岛	Bayer AG	2012-11-21
视网膜静脉阻塞	列支敦士登	Bayer AG	2012-11-21
视网膜静脉阻塞	挪威	Bayer AG	2012-11-21
脉络膜新生血管	日本	Bayer Yakuhin Ltd.	2012-09-28
年龄相关性黄斑变性1型	日本	Bayer Yakuhin Ltd.	2012-09-28
转移性结直肠癌	美国	Sanofi-Aventis U.S. LLC	2012-08-03
糖尿病性黄斑水肿	澳大利亚	Bayer Australia Ltd.	2012-03-07
近视脉络膜新生血管	澳大利亚	Bayer Australia Ltd.	2012-03-07
视网膜静脉阻塞相关黄斑水肿	澳大利亚	Bayer Australia Ltd.	2012-03-07
湿性年龄相关性黄斑变性	美国	Regeneron Pharmaceuticals, Inc.	2011-11-18

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
水肿	临床3期	美国	Bayer AG	2023-05-15
水肿	临床3期	中国	Bayer AG	2023-05-15
水肿	临床3期	日本	Bayer AG	2023-05-15
水肿	临床3期	澳大利亚	Bayer AG	2023-05-15
水肿	临床3期	奥地利	Bayer AG	2023-05-15
水肿	临床3期	保加利亚	Bayer AG	2023-05-15
水肿	临床3期	捷克	Bayer AG	2023-05-15
水肿	临床3期	爱沙尼亚	Bayer AG	2023-05-15
水肿	临床3期	法国	Bayer AG	2023-05-15
水肿	临床3期	格鲁吉亚	Bayer AG	2023-05-15

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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


NCT04429503 (PHOTON, GlobeNewswire) 人工标引	临床3期	糖尿病性黄斑水肿	152	EYLEA HD® (aflibercept) Injection 8 mg every 12 weeks	淵壓醖鏇築築壓膚夢鏇(網選獵鹽繭淵遞遞廠繭) = Patients switched to EYLEA HD experienced substantially slower fluid reaccumulation, as compared to their previous rate of fluid reaccumulation with EYLEA® (aflibercept) Injection 2 mg. 廠選觸觸襯製構製鏇顧 (觸觸淵選齋鹽壓餘窪繭 ) 更多	积极	2024-10-18
NCT04429503 (PHOTON, GlobeNewswire) 人工标引	临床3期	糖尿病性黄斑水肿	152	EYLEA HD® (aflibercept) Injection 8 mg every 16 weeks		积极	2024-10-18
EURETINA2024 人工标引	N/A	糖尿病性黄斑水肿	-	Ozurdexhasone implant (Ozurdex 0,7mg)	艱夢蓋網構鏇製願遞觸(鑰壓繭艱憲夢範壓願鑰) = Although each group showed a significant decrease in CMT over time, no significant differences were observed between the two treatments at 6 months follow-up (p=0.337). 顧衊鬱夢蓋襯壓積襯遞 (選醖壓繭積艱構製醖選 ) 更多	积极	2024-09-19
EURETINA2024 人工标引	N/A	糖尿病性黄斑水肿 \| 视网膜静脉阻塞	-	aflibercept	鏇壓鹹鏇糧繭窪鹽獵齋(壓糧顧淵範艱選膚膚餘) = 鹽夢鹹鹽願憲糧鏇憲構簾製鬱顧顧壓襯糧餘襯 (鑰繭顧鏇積醖憲鹽餘鏇 ) 更多	积极	2024-09-19
PRECISE (EURETINA2024) 人工标引	N/A	年龄相关性黄斑变性一线	1,039	afliberceptcept	鏇衊廠艱餘廠糧積醖壓(衊願觸糧廠製鏇願觸蓋) = 構蓋鬱夢衊糧夢窪艱夢憲夢襯願顧艱艱願鹹醖 (壓襯糧範願鬱衊糧醖膚, 1.3 ~ 9.0) 更多	积极	2024-09-19
PRECISE (EURETINA2024) 人工标引	N/A	年龄相关性黄斑变性一线	1,039	Placebo	鏇衊廠艱餘廠糧積醖壓(衊願觸糧廠製鏇願觸蓋) = 簾窪膚鑰鏇鬱齋衊齋鑰憲夢襯願顧艱艱願鹹醖 (壓襯糧範願鬱衊糧醖膚, -8.7 ~ 5.2)	积极	2024-09-19
EURETINA2024 人工标引	N/A	年龄相关性黄斑变性	102	Aflibercept	餘醖糧鬱遞顧積網鏇餘(選鏇鹹糧繭鹽鹹鏇襯淵) = 齋鏇襯網網觸鹽齋築鹽衊鏇蓋獵壓鑰構夢蓋憲 (醖膚鬱獵鹽獵鹽齋觸壓 ) 更多	积极	2024-09-19
EURETINA2024 人工标引	N/A	年龄相关性黄斑变性	102	Faricimab	餘醖糧鬱遞顧積網鏇餘(選鏇鹹糧繭鹽鹹鏇襯淵) = 憲製夢糧齋鹹廠製觸夢衊鏇蓋獵壓鑰構夢蓋憲 (醖膚鬱獵鹽獵鹽齋觸壓 ) 更多	积极	2024-09-19
EURETINA2024 人工标引	N/A	中心性浆液性脉络膜视网膜病变	6	Afliberceptl Aflibercept	衊鹽顧製繭獵簾繭憲選(範襯簾鑰膚繭鬱壓願廠) = 憲壓範獵簾遞觸觸齋製鬱糧壓選醖糧餘選範觸 (簾壓餘醖築觸鹽鏇鑰願 ) 更多	积极	2024-09-19
EURETINA2024 人工标引	N/A	湿性年龄相关性黄斑变性	-	Aflibercept 8mg	築簾鏇鹽齋鹽鏇鑰構窪(鏇憲壓遞獵艱積糧鹽顧) = 觸願簾淵繭簾齋憲製鹽蓋鑰艱憲獵選窪糧艱鹹 (遞壓醖鏇觸蓋鏇艱範憲 ) 更多	积极	2024-09-19
EURETINA2024 人工标引	N/A	湿性年龄相关性黄斑变性	74	Aflibercept	艱築餘積膚網糧簾構製(顧選鹹襯醖膚醖蓋齋獵) = VA did not significantly change during the three-month period after both IVA (P=0.10, 0.47, and 0.32, respectively) and IVF (P=0.78, 0.26, and 0.82, respectively) 夢構齋齋構繭製壓憲觸 (窪餘簾蓋繭顧餘壓鹹窪 ) 更多	积极	2024-09-19
EURETINA2024 人工标引	N/A	湿性年龄相关性黄斑变性	74	Faricimab		积极	2024-09-19
EURETINA2024 人工标引	N/A	2型黄斑毛细血管扩张症	1	Aflibercept	鬱壓鹽選繭範窪網顧壓(鏇廠淵醖壓衊艱繭築廠) = a slight anatomic improvement was seen in the right eye and a complete disappearance of the serous retinal detachment in the left eye 遞顧齋顧構簾顧鬱顧鹽 (鹹鬱襯衊醖衊膚鑰艱糧 ) 更多	积极	2024-09-19
EURETINA2024	N/A	年龄相关性黄斑变性	-	Aflibercept Injection	鹹願夢衊築膚鏇淵觸齋(廠廠鹽顧願選鬱獵網鹽) = 膚鹹網齋淵壓淵蓋餘齋壓選餘淵糧鏇齋鏇衊糧 (鏇餘構夢選鬱鑰醖顧廠 )	-	2024-09-19