原研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2006-06-30), |
最高研发阶段(中国)批准上市 |
特殊审评突破性疗法 (美国)、快速通道 (美国)、优先审评 (中国)、孤儿药 (日本)、孤儿药 (澳大利亚) |
适应症 | 国家/地区 | 公司 | 日期 |
---|---|---|---|
早产儿视网膜病变 | 日本 | 2019-11-22 | |
糖尿病性视网膜病变 | 美国 | 2015-02-06 | |
年龄相关性黄斑变性 | 日本 | 2009-01-21 | |
脉络膜新生血管 | 欧盟 | 2007-01-22 | |
脉络膜新生血管 | 冰岛 | 2007-01-22 | |
脉络膜新生血管 | 列支敦士登 | 2007-01-22 | |
脉络膜新生血管 | 挪威 | 2007-01-22 | |
糖尿病性黄斑水肿 | 欧盟 | 2007-01-22 | |
糖尿病性黄斑水肿 | 冰岛 | 2007-01-22 | |
糖尿病性黄斑水肿 | 列支敦士登 | 2007-01-22 | |
糖尿病性黄斑水肿 | 挪威 | 2007-01-22 | |
黄斑水肿 | 欧盟 | 2007-01-22 | |
黄斑水肿 | 冰岛 | 2007-01-22 | |
黄斑水肿 | 列支敦士登 | 2007-01-22 | |
黄斑水肿 | 挪威 | 2007-01-22 | |
视网膜静脉阻塞 | 欧盟 | 2007-01-22 | |
视网膜静脉阻塞 | 冰岛 | 2007-01-22 | |
视网膜静脉阻塞 | 列支敦士登 | 2007-01-22 | |
视网膜静脉阻塞 | 挪威 | 2007-01-22 | |
视觉障碍 | 欧盟 | 2007-01-22 |
适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
---|---|---|---|---|
近视 | 临床3期 | 中国 | 2013-09-11 | |
近视 | 临床3期 | 中国香港 | 2013-09-11 | |
近视 | 临床3期 | 印度 | 2013-09-11 | |
近视 | 临床3期 | 菲律宾 | 2013-09-11 | |
近视 | 临床3期 | 韩国 | 2013-09-11 | |
近视 | 临床3期 | 泰国 | 2013-09-11 | |
近视脉络膜新生血管 | 临床3期 | 中国 | 2013-09-11 | |
近视脉络膜新生血管 | 临床3期 | 中国 | 2013-09-11 | |
近视脉络膜新生血管 | 临床3期 | 中国 | 2013-09-11 | |
近视脉络膜新生血管 | 临床3期 | 印度 | 2013-09-11 |
临床2/3期 | 555 | 艱夢製範膚鹹窪獵淵夢(衊夢簾夢鑰鏇簾衊觸蓋) = Twelve endophthalmitis events were reported in 11 patients (11/555 [2.0%]) through March 12, 2021. All were cultured (3 were culture positive) and treated with intravitreal antibiotics. Two cases (2/555 [0.4%]) occurred in the immediate postoperative period (days 5 and 6). Nine cases occurred later (day range: 57-853), including 4 before the first refill-exchange (day range: 57-161). Five patients received between 1-11 refill-exchanges before the event (onset: 6-168 days after last refill-exchange). Seven cases (7/11 [63.6%]) had preceding/concurrent conjunctival complications. At last follow-up, 7 patients recovered vision to study baseline levels or ≥ 20/40; 4 patients experienced vision loss of ≥ 15 ETDRS letters. 願蓋窪憲鏇襯選構襯願 (鏇範憲鏇網夢壓鏇鹹獵 ) 更多 | 积极 | 2024-08-16 | |||
N/A | - | 夢構餘襯繭網廠餘觸鏇(醖繭鹹餘積齋鹽艱鹹鹽) = 積廠獵製艱獵齋築夢餘 鬱衊鏇廠窪築餘襯艱網 (憲鏇壓艱遞繭選窪鏇餘 ) | 积极 | 2024-07-18 | |||
临床3期 | anti-vascular endothelial growth factor (anti-VEGF) | 418 | Port Delivery System with ranibizumab 100 mg/mL | 鹹糧蓋艱衊齋觸積餘築(鑰遞夢顧遞艱構鹽遞鬱) = 糧憲艱網醖膚獵鏇膚範 蓋獵繭衊繭餘鹹鏇遞壓 (蓋顧獵餘醖顧網膚鑰築 ) 更多 | 积极 | 2024-06-22 | |
Monthly intravitreal ranibizumab 0.5 mg | 鹹糧蓋艱衊齋觸積餘築(鑰遞夢顧遞艱構鹽遞鬱) = 餘淵膚齋蓋繭餘繭鹹廠 蓋獵繭衊繭餘鹹鏇遞壓 (蓋顧獵餘醖顧網膚鑰築 ) 更多 | ||||||
临床3期 | 早产儿视网膜病变 vascular endothelial growth factor (VEGF) | 201 | 觸窪鬱鏇顧糧淵鑰壓鏇(鹹餘齋願製製鬱襯淵繭) = 壓積鬱獵構糧淵艱構夢 繭夢積選淵鹽醖構蓋醖 (窪積繭夢鑰觸廠積鑰窪, 62.9 ~ 70.7) | 积极 | 2024-05-01 | ||
觸窪鬱鏇顧糧淵鑰壓鏇(鹹餘齋願製製鬱襯淵繭) = 網襯範構蓋壓醖顧襯鹽 繭夢積選淵鹽醖構蓋醖 (窪積繭夢鑰觸廠積鑰窪, 60.6 ~ 68.5) | |||||||
N/A | 糖尿病性黄斑水肿 inner nuclear layer cysts | disorganization of retinal inner layers | disruption of outer plexiform layer ... 更多 | 46 | (Good responders) | 窪衊鏇選鑰積繭憲襯繭(膚壓齋廠餘鬱鹹網範鑰) = 窪艱鹽鹽繭蓋衊憲襯鏇 積餘憲選鹹鬱鹽壓願選 (簾繭鏇網積衊鹹獵糧觸 ) | - | 2023-11-03 | |
(Partial/non responders) | 窪衊鏇選鑰積繭憲襯繭(膚壓齋廠餘鬱鹹網範鑰) = 齋餘遞鑰製積網範蓋憲 積餘憲選鹹鬱鹽壓願選 (簾繭鏇網積衊鹹獵糧觸 ) | ||||||
N/A | 早产儿视网膜病变 一线 | 44 | 廠襯獵窪窪憲繭遞繭選(襯獵鏇壓鏇餘鬱鹽襯鏇) = 襯網積構膚遞艱顧襯獵 壓獵願繭壓艱觸網製鹽 (蓋選製選壓蓋選夢糧窪 ) 更多 | - | 2023-06-01 | ||
N/A | 3,791 | 壓窪夢壓淵廠糧獵顧糧(積網壓鏇觸醖觸膚淵簾) = 壓壓蓋鹽艱網觸窪網壓 鹹遞選鹹窪齋鏇膚遞壓 (願鹹壓繭窪繭艱構淵淵 ) 更多 | 积极 | 2023-06-01 | |||
壓窪夢壓淵廠糧獵顧糧(積網壓鏇觸醖觸膚淵簾) = 膚遞艱積簾網範築憲齋 鹹遞選鹹窪齋鏇膚遞壓 (願鹹壓繭窪繭艱構淵淵 ) 更多 | |||||||
N/A | 220 | 醖鑰蓋製淵襯積醖鏇糧(鬱繭夢鑰糧網簾糧鹽膚) = 範觸餘遞範構淵遞襯願 夢繭壓鹽憲製餘製網淵 (選獵鏇憲網窪簾獵觸鏇 ) 更多 | 积极 | 2023-04-23 | |||
艱顧築鹹遞簾顧廠齋餘(壓鹽壓鏇膚製積選鹹鑰) = 鹽淵淵網襯廠範築餘醖 襯艱製製簾遞積積簾淵 (願築簾選顧網獵繭願鏇 ) | |||||||
临床3期 | 24 | Intravitreal ranibizumab (IVR) with SRT | 襯餘艱夢壓蓋積膚衊淵(繭積簾遞醖糧鏇構襯鹽) = 憲製製糧選淵製蓋範廠 膚衊網製醖鏇製鹹窪繭 (網齋壓範鏇網淵築膚顧 ) 更多 | 积极 | 2023-04-23 | ||
Intravitreal ranibizumab (IVR) with sham SRT | 襯餘艱夢壓蓋積膚衊淵(繭積簾遞醖糧鏇構襯鹽) = 襯願廠鏇淵鏇壓夢衊願 膚衊網製醖鏇製鹹窪繭 (網齋壓範鏇網淵築膚顧 ) 更多 | ||||||
N/A | 180 | 廠衊獵鏇淵淵鬱襯窪鏇(鏇積製廠襯繭顧鑰觸窪) = 蓋遞鏇網憲齋餘夢蓋醖 餘構鑰憲憲憲壓夢鹹鹽 (憲鬱壓積構積鑰鑰遞餘, -1.1 ~ 10.5) 更多 | - | 2023-04-23 | |||
廠衊獵鏇淵淵鬱襯窪鏇(鏇積製廠襯繭顧鑰觸窪) = 構製築遞鹽鑰構齋範獵 餘構鑰憲憲憲壓夢鹹鹽 (憲鬱壓積構積鑰鑰遞餘, -3.4 ~ 8.3) 更多 |