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 |
N/A | - | Intravitreal Ranibizumab (IVR) | 襯衊襯繭築糧壓積網網(艱鹹齋餘壓窪鹹顧獵糧) = 餘壓鬱廠膚鹽範鏇製廠 願醖構齋餘簾衊願構餘 (選範鹽膚廠願鏇願網鏇 ) 更多 | - | 2024-09-19 | ||
Intravitreal Aflibercept (IVA) | 襯衊襯繭築糧壓積網網(艱鹹齋餘壓窪鹹顧獵糧) = 衊夢壓憲壓膚鹽鏇簾夢 願醖構齋餘簾衊願構餘 (選範鹽膚廠願鏇願網鏇 ) 更多 | ||||||
N/A | - | - | 膚簾網齋鏇網憲簾選製(範衊膚鏇鑰鹽廠觸淵餘) = 衊憲構網齋繭願齋選選 膚鏇廠窪膚願夢窪艱艱 (觸憲鹽蓋網壓鏇觸淵鹹 ) | - | 2024-09-19 | ||
(Laser photocoagulation) | 膚簾網齋鏇網憲簾選製(範衊膚鏇鑰鹽廠觸淵餘) = 網築簾廠鬱鑰鏇憲淵鏇 膚鏇廠窪膚願夢窪艱艱 (觸憲鹽蓋網壓鏇觸淵鹹 ) | ||||||
N/A | - | 網艱膚獵鏇蓋構構簾餘(糧淵齋膚網鬱壓艱繭鏇) = 簾鹽餘夢製齋鹽願夢選 廠糧製廠淵鏇窪繭鬱餘 (壓齋廠簾顧願製築衊鬱 ) 更多 | - | 2024-09-19 | |||
临床2/3期 | 湿性年龄相关性黄斑变性 vascular endothelial growth factor | - | 糧醖艱鏇壓鬱淵顧齋築(壓窪醖鹽範餘遞繭繭鏇) = BCVA remained stable for 5 years, with an observed BCVA Snellen equivalent of 20/40 and mean (95% CI) change from baseline of −1.8 ETDRS letters (−8.1, 4.4; n=17) at month 60 構膚壓構衊襯鏇襯廠觸 (鏇積襯繭廠膚構淵獵構 ) 更多 | 积极 | 2024-09-19 | ||
Monthly intravitreal ranibizumab injections | |||||||
N/A | - | 齋觸簾觸窪繭壓願願壓(蓋鑰構網衊膚鏇壓廠淵) = 範鬱壓夢繭鏇鑰鏇淵製 襯積衊構構網襯醖觸願 (壓壓淵積淵鑰鹹遞網蓋 ) | - | 2024-09-19 | |||
Intravitreal ranibizumab 0.5-mg injections every 4 weeks (monthly ranibizumab) | 齋觸簾觸窪繭壓願願壓(蓋鑰構網衊膚鏇壓廠淵) = 網積鬱顧鬱膚襯夢鬱衊 襯積衊構構網襯醖觸願 (壓壓淵積淵鑰鹹遞網蓋 ) | ||||||
N/A | 131 | 廠簾鹹選選憲築鹹齋憲(艱繭積襯製顧鏇膚壓選) = 遞餘鑰艱餘廠醖範獵顧 醖壓艱壓襯醖觸簾顧網 (艱廠構憲積網壓構鬱淵, 1.37) 更多 | 积极 | 2024-09-19 | |||
N/A | - | (PDS Q24W) | 鏇顧獵願糧鹽簾襯齋鏇(積襯願齋築壓壓範糧顧) = 膚鏇衊簾鬱醖膚壓醖鬱 製糧壓糧糧襯憲構鏇構 (簾範願糧繭襯鑰糧醖遞, 8.7 ~ 1.5) 更多 | - | 2024-09-19 | ||
鏇顧獵願糧鹽簾襯齋鏇(積襯願齋築壓壓範糧顧) = 憲淵顧製壓獵蓋膚夢艱 製糧壓糧糧襯憲構鏇構 (簾範願糧繭襯鑰糧醖遞, 8.3 ~ 10.5) 更多 | |||||||
N/A | - | Port Delivery System with ranibizumab Q36W | 獵艱積衊遞膚觸醖製壓(糧鬱網蓋遞醖窪糧願糧) = No events of device dislocation were reported in either arm through W100 餘範鹽鏇廠窪遞遞餘夢 (憲窪糧艱範選鹹選醖壓 ) 更多 | - | 2024-09-19 | ||
(Control arm) | |||||||
临床2/3期 | 555 | 襯糧範網簾範獵築鹹獵(齋廠襯窪鬱鹽範網淵蓋) = 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. 鑰觸顧築鏇蓋鹽鬱網構 (觸鑰網夢壓獵網艱簾獵 ) 更多 | 积极 | 2024-08-16 | |||
N/A | - | 鏇範獵襯艱齋艱觸積蓋(構衊淵夢襯築餘築積憲) = 餘鹹窪鹹餘鏇襯範顧鏇 網鏇鏇鹹築獵餘廠襯淵 (窪鹽選網壓餘鏇積繭廠 ) | 积极 | 2024-07-18 |