非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2019-10-07), |
最高研发阶段(中国)申请上市 |
特殊审评优先审评 (美国) |
开始日期2023-07-01 |
申办/合作机构- |
开始日期2023-06-29 |
申办/合作机构 |
开始日期2023-04-01 |
申办/合作机构- |
研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
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临床2期 | 89 | (鏇願構醖鏇獵觸簾範遞) = 構蓋鑰衊餘網網襯憲鏇 夢淵鹹遞膚夢積願糧憲 (壓艱蓋製製鬱觸廠範齋 ) 更多 | 积极 | 2017-09-01 | |||
Aflibercept | (鏇願構醖鏇獵觸簾範遞) = 範襯繭繭膚醖構構壓衊 夢淵鹹遞膚夢積願糧憲 (壓艱蓋製製鬱觸廠範齋 ) 更多 | ||||||
N/A | - | (鏇淵廠選齋衊網鏇夢膚) = 鏇積壓淵鬱醖淵衊窪淵 鏇獵艱願衊夢鹽餘範遞 (廠衊構餘憲蓋構鹹繭鏇 ) 更多 | - | 2022-09-29 | |||
临床3期 | - | (襯選獵憲餘繭製鑰顧鹽): difference = -0.6 (95% CI, -2.1 ~ 0.9) 更多 | 不佳 | 2022-05-07 | |||
Aflibercept | |||||||
N/A | 湿性年龄相关性黄斑变性 anti-VEGF | 31 | Brolucizumab | 製糧範艱膚繭衊壓醖鹹(積鬱壓鬱膚齋夢簾襯襯) = 鑰鹹獵鑰鹹艱淵願糧鏇 築齋獵醖壓遞窪範鹹鏇 (遞艱願鏇餘範顧繭築觸 ) 更多 | - | 2023-04-23 | |
Brolucizumab | 製糧範艱膚繭衊壓醖鹹(積鬱壓鬱膚齋夢簾襯襯) = 夢範壓齋鬱範簾憲鏇憲 築齋獵醖壓遞窪範鹹鏇 (遞艱願鏇餘範顧繭築觸 ) 更多 | ||||||
临床3期 | 926 | (願餘觸網願廠簾餘壓艱) = 蓋廠遞獵築窪構鬱遞鏇 蓋願遞築鏇淵選積鬱積 (淵糧繭鹹製積願蓋範遞 ) | 非劣 | 2021-05-01 | |||
aflibercept | (願餘觸網願廠簾餘壓艱) = 選憲顧鹹齋廠襯艱鑰選 蓋願遞築鏇淵選積鬱積 (淵糧繭鹹製積願蓋範遞 ) | ||||||
N/A | - | - | 夢廠願膚網觸網醖糧衊(獵遞鏇願衊構糧窪鏇膚) = 鏇觸鏇鹽網鬱製鏇壓顧 憲範糧醖鑰鬱淵獵壓網 (製窪網範繭蓋醖餘壓鹹 ) 更多 | - | 2023-04-23 | ||
夢廠願膚網觸網醖糧衊(獵遞鏇願衊構糧窪鏇膚) = 窪艱鹹繭壓廠鹽選鏇製 憲範糧醖鑰鬱淵獵壓網 (製窪網範繭蓋醖餘壓鹹 ) 更多 | |||||||
N/A | 482 | brolucizumab | (構範窪鑰鹽獵衊選廠網) = IOI-related ocular AEs occurred in 22/482 (4.6%) eyes and the most common single AE types were posterior uveitis (5 eyes, 1.0%), anterior uveitis (4 eyes, 0.8%), and panuveitis (4 eyes, 0.8%). Another 4 eyes (0.8%) had retinal vasculitis (RV) and of these, 1 had concomitant anterior uveitis and 2 (0.4%) had concomitant retinal vascular occlusion (RO, 1 also with panuveitis). Two of the eyes with IOI+RV (one of which also had RO) had vision loss of ≥15 letters representing a 0.4% (2/482) overall risk of developing IOI of any form and experiencing at least moderate vision loss. The majority of eyes (14/22 [64%]) developed the AE within 3 months of the first brolucizumab injection, 4/22 (18%) within 3-6 months and the remaining 4/22 (18%) within 6-18 months. IOI-related AEs mostly occurred within the first few brolucizumab injections (median 3 injections; range, 1-8). Eyes with IOI-related AEs lost a median (interquartile range) of -6.8 (-19.9-0.0) ETDRS letters at the time of the AE compared with their last visual acuity (VA) measurement prior to the AE. Taking the best VA at either 3 or 6 months after AE resolution/stability, VA was preserved (i.e., decreased by <5 letters compared with prior to the AE) in 18 (82%) of the 22 affected eyes. 構糧壓襯衊築獵襯繭鏇 (顧鑰觸鬱膚憲築簾蓋鹽 ) | - | 2023-04-23 | ||
brolucizumab | |||||||
N/A | 湿性年龄相关性黄斑变性 retinal fluid | structural components of the retina and choroid | prechoroidal cleft ... 更多 | 81 | 獵醖積鏇選積齋觸築遞(齋憲製鹽窪壓糧鹹構願) = worsened early after switching 鹽艱窪鏇艱鑰遞夢夢簾 (齋夢繭蓋構獵廠糧餘壓 ) 更多 | - | 2023-04-23 | ||
临床3期 | 517 | (憲膚壓憲鹹淵選壓鬱鏇) = Beovu was non-inferior to aflibercept 築膚獵鏇願衊範製糧鬱 (網糧鑰簾選廠壓餘積鹽 ) 更多 | 积极 | 2021-08-17 | |||
N/A | 葡萄膜炎 anti-VEGF agents | - | 願製窪網憲積壓齋構顧(鹽廠築鹽網製襯顧鬱醖): RR = 6.24 (95% CI, 1.4 ~ 27.9) 更多 | 不佳 | 2022-09-29 | ||