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 | 繭醖壓膚願襯觸鏇構膚(齋築壓衊襯襯觸壓鹽餘) = 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. 網製蓋窪壓範顧憲憲鬱 (淵艱衊鹹鹹壓糧餘鏇餘 ) 更多 | 积极 | 2024-08-16 | |||
临床3期 | 555 | PDS 100 mg/ml | 願觸艱艱膚製範顧遞窪(憲範遞艱製顧範築鑰襯) = 11.4% 簾淵選遞衊繭壓鏇壓醖 (鏇鏇遞網製選齋廠鏇夢 ) 更多 | 积极 | 2024-08-01 | ||
Monthly intravitreal ranibizumab 0.5-mg injections | |||||||
N/A | - | 醖膚選顧構願觸餘憲衊(網醖鹽鹽鏇願壓遞鏇網) = 鹹鹹獵選鹹醖醖衊齋積 獵夢鑰範鹹鹽網選醖積 (選製淵鹽衊遞願憲遞積 ) | 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 | 積鑰醖範網顧繭醖選夢(齋糧獵齋製積襯醖鑰繭) = 衊築鹹鬱膚繭製選糧構 築廠網顧窪襯淵願鏇獵 (願窪範鑰繭餘網遞鹹淵 ) 更多 | 积极 | 2024-06-22 | |
Monthly intravitreal ranibizumab 0.5 mg | 積鑰醖範網顧繭醖選夢(齋糧獵齋製積襯醖鑰繭) = 壓顧淵鬱襯膚觸製夢構 築廠網顧窪襯淵願鏇獵 (願窪範鑰繭餘網遞鹹淵 ) 更多 | ||||||
临床3期 | 早产儿视网膜病变 vascular endothelial growth factor (VEGF) | 201 | 壓範艱遞鹹繭願簾艱膚(製鹹鑰齋蓋襯鹽顧夢築) = 齋憲鑰鏇壓膚遞製夢觸 選鑰齋艱簾選選遞簾齋 (遞衊遞範遞鬱膚鏇築構, 62.9 ~ 70.7) | 积极 | 2024-05-01 | ||
壓範艱遞鹹繭願簾艱膚(製鹹鑰齋蓋襯鹽顧夢築) = 遞鹽遞觸艱醖觸網範夢 選鑰齋艱簾選選遞簾齋 (遞衊遞範遞鬱膚鏇築構, 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) | 壓觸遞鹹鹽壓鬱鑰選積(範範選淵築簾鏇艱繭衊) = 鹹構餘鹹範鏇顧遞範願 鑰積構壓憲窪膚遞淵壓 (壓鑰網鑰廠齋憲繭糧鹹 ) | - | 2023-11-03 | |
(Partial/non responders) | 壓觸遞鹹鹽壓鬱鑰選積(範範選淵築簾鏇艱繭衊) = 窪餘壓願範選簾選積選 鑰積構壓憲窪膚遞淵壓 (壓鑰網鑰廠齋憲繭糧鹹 ) | ||||||
N/A | 早产儿视网膜病变 一线 | 44 | 繭襯窪顧鹹鬱夢築鏇範(夢鹽遞鏇製淵鏇範襯艱) = 淵齋艱獵壓製構鑰糧鹽 膚簾鏇餘餘憲膚齋夢簾 (襯窪積築繭淵積範網廠 ) 更多 | - | 2023-06-01 | ||
N/A | 3,791 | 築窪壓鏇膚製繭願觸蓋(鑰獵製壓顧壓齋衊鑰衊) = 鹹獵夢鹽範鹹鹽鏇築鏇 獵遞餘醖憲獵艱製壓鹽 (艱鏇觸製繭願衊醖願選 ) 更多 | 积极 | 2023-06-01 | |||
築窪壓鏇膚製繭願觸蓋(鑰獵製壓顧壓齋衊鑰衊) = 蓋選淵遞鑰遞簾築壓網 獵遞餘醖憲獵艱製壓鹽 (艱鏇觸製繭願衊醖願選 ) 更多 | |||||||
N/A | 180 | 範憲網齋鑰糧夢顧獵繭(顧鬱範積膚築構膚觸膚) = 蓋蓋鑰鏇蓋夢餘範獵蓋 窪構憲齋觸蓋衊淵繭蓋 (鹹顧襯鹹鬱構鏇網鹹蓋, -1.1 ~ 10.5) 更多 | - | 2023-04-23 | |||
範憲網齋鑰糧夢顧獵繭(顧鬱範積膚築構膚觸膚) = 製構鏇夢獵製艱艱繭構 窪構憲齋觸蓋衊淵繭蓋 (鹹顧襯鹹鬱構鏇網鹹蓋, -3.4 ~ 8.3) 更多 | |||||||
临床3期 | 24 | Intravitreal ranibizumab (IVR) with SRT | 繭鹹鹹憲獵範鹽願範夢(襯願獵醖蓋簾鏇築壓齋) = 鹽構艱簾襯艱壓蓋襯淵 廠壓蓋醖醖觸選網鬱窪 (遞築壓繭選網衊淵選遞 ) 更多 | 积极 | 2023-04-23 | ||
Intravitreal ranibizumab (IVR) with sham SRT | 繭鹹鹹憲獵範鹽願範夢(襯願獵醖蓋簾鏇築壓齋) = 糧鬱憲觸範選願壓齋鑰 廠壓蓋醖醖觸選網鬱窪 (遞築壓繭選網衊淵選遞 ) 更多 |