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更新于：2026-03-04
Lifitegrast
利非司特
更新于：2026-03-04
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (2016-07-11), |
最高研发阶段(中国)临床3期 |
特殊审评- |
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结构/序列
分子式C29H24Cl2N2O7S |
InChIKeyJFOZKMSJYSPYLN-QHCPKHFHSA-N |
CAS号1025967-78-5 |
关联
39
项与 利非司特 相关的临床试验NCT07111013
A 12-Month, Multicenter, Open-Label Extension (OLE) Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease
NCT07128628
A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease
CTRI/2025/07/091185
A Comparative study of Chloroquine Cyclosporine and Lifitegrast in the management of Dry eye Disease-Clarity Trial - CLARITY
100 项与 利非司特 相关的临床结果
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100 项与 利非司特 相关的专利（医药）
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120
项与 利非司特 相关的文献（医药）2026-02-17Seminars in Ophthalmology
Recent Advances in Targeted Immunomodulatory Therapies for Chronic Ocular Surface Diseases
Review
作者: Genovese, Riccardo ; Mori, Tommaso ; Sgrulletta, Roberto ; Cutrupi, Francesco ; Surico, Pier Luigi ; Leonardi, Andrea ; Coassin, Marco ; Spelta, Sara ; Di Zazzo, Antonio
PURPOSE:
To review and compare the mechanisms of action, clinical efficacy, and safety profiles of topical immunosuppressive and immunomodulatory agents for the management of chronic ocular surface diseases.
METHODS:
A comprehensive review of the literature was conducted using PubMed, Scopus, and Web of Science databases. Peer-reviewed clinical trials, observational studies, case series, and meta-analyses from 1960 to 2024 were included. Studies were selected based on their investigation of the efficacy and safety of topical therapies for chronic ocular surface diseases. Systemic therapies and non-ocular conditions were excluded.
RESULTS:
Corticosteroids remain effective in controlling acute inflammation but are associated with significant adverse effects, particularly with long-term use, including elevated intraocular pressure, cataract formation, and infection risk. In contrast, targeted immunomodulators such as cyclosporine, tacrolimus, lifitegrast, tofacitinib, and reproxalap provide more selective modulation of the immune response. These agents have demonstrated favorable tolerability and efficacy in chronic ocular surface diseases, including dry eye disease, vernal keratoconjunctivitis, and ocular GVHD. Recent advances include IL-1 receptor antagonists, JAK inhibitors, RASP inhibitors, and mitochondrial-targeted antioxidants.
CONCLUSIONS:
While corticosteroids are indispensable for acute management, targeted immunomodulatory therapies offer a safer and more sustainable approach for long-term treatment of chronic ocular surface inflammation. The emergence of novel topical agents supports a shift toward precision immunotherapy in ophthalmology.
2025-10-01Ocular Surface
Topical pharmacologic treatments for dry eye disease: A systematic review
Review
作者: Gümüş, Koray ; Şahin, Afsun ; Liu, Zuguo ; Benítez-Del-Castillo, José M ; Tong, Louis ; Chan, Clara C ; Periman, Laura M ; Messmer, Elisabeth M ; Labetoulle, Marc
BACKGROUND:
Topical pharmacologic treatments for dry eye disease (DED) address different aspects of tear film deficiency by decreasing ocular surface inflammation, stimulating mucin secretion, increasing tear production, or reducing excessive evaporation. This systematic review evaluated randomized controlled trials (RCTs) and prospective observational studies of topical ophthalmic medications for DED.
METHODS:
PubMed and Embase were searched from 1980 to February 2024. For studies meeting inclusion criteria, efficacy outcomes (signs and symptoms of DED) and adverse event data were extracted.
RESULTS:
A total of 107 publications covering topical prescription medications (anti-inflammatory agents cyclosporine and lifitegrast; mucin secretagogues diquafosol and rebamipide; tear evaporation inhibitor perfluorohexyloctane; tear production stimulator nasal spray varenicline), other commercially available products, and novel agents in development were identified. In RCTs, significant improvements relative to a control group were demonstrated more often for sign endpoints (e.g., corneal staining, Schirmer score) than for symptom endpoints (e.g., eye dryness, ocular discomfort). The evaluated treatments were well tolerated; instillation site reactions were the most commonly reported adverse events. Year-long safety extension studies demonstrated maintenance of efficacy, with no new safety signals identified. Studies differed in design, methodology, control group, and outcomes assessment, making it difficult to compare across products, and head-to-head studies were rare. Several new products are in late-stage development, which will likely lead to additional treatment options.
CONCLUSIONS:
Current topical pharmacologic eye products improved signs, and sometimes symptoms, of DED and were well tolerated. Treatment selection should use a shared decision-making approach that takes DED etiology and patient preferences into account.
2025-09-14OCULAR IMMUNOLOGY AND INFLAMMATION
Pharmacovigilance Analysis of Lifitegrast-Associated Adverse Events Using the FDA Adverse Event Reporting System (FAERS) Database
Article
作者: Liu, Zhijing ; Chen, Maohua ; Wu, Dongzhi ; Ke, Chengjie ; Zhang, Tao ; He, Wenhui
BACKGROUND:
Lifitegrast is the first lymphocyte function-associated antigen-1 antagonist approved by the United States Food and Drug Administration (FDA) for the treatment of the signs and symptoms of dry eye disease. Its safety has not been fully elucidated in a real-world analysis. Thus, we conducted a pharmacovigilance analysis using data on lifitegrast-associated adverse events (AEs) from the FDA's adverse event reporting system (FAERS).
METHODS:
A comprehensive search of the FAERS database was conducted to extract all available data on lifitegrast from the time of its initial market release (July 2016) until March 2024. Signals of lifitegrast-associated AEs were quantified by calculating reporting odds ratio, proportional reporting ratio, information component, and empirical Bayesian geometric mean.
RESULTS:
In total 12 929,815 AE reports were collected from the FAERS database. Lifitegrast was deemed the primary suspect in 12 390 of these reports. Comprehensive analysis using four algorithms resulted in the identification and retention of 179 preferred terms exhibiting significant disproportionality. In addition to known AEs, unexpected and novel AEs, such as hypoacusis, instillation site infection, temporomandibular joint syndrome, and reduced blood folate levels, were identified.
CONCLUSION:
Most lifitegrast-related AEs identified in this study were consistent with those described on the drug label, but some other signals potentially associated with lifitegrast were identified. Prospective studies are needed to verify and clarify these AEs' relationship to lifitegrast.
100 项与 利非司特 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 干眼综合征 | 美国 | 2016-07-11 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 干眼症 | 临床3期 | 中国 | 2022-02-17 | |
| 干眼症 | 临床3期 | 中国 | 2022-02-17 | |
| 干燥综合征性角膜结膜炎 | 临床3期 | 美国 | 2011-08-29 | |
| 变应性结膜炎 | 临床2期 | 美国 | 2009-04-24 | |
| 慢性移植物抗宿主病 | 临床1期 | 美国 | 2022-10-22 | |
| 糖尿病性黄斑水肿 | 临床1期 | 美国 | 2009-08-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床4期 | 45 | 壓顧簾艱蓋築窪鏇襯選(獵膚夢窪艱構簾選願繭) = 選顧願鹽繭製夢簾選遞 願繭築鹽願淵廠網艱衊 (鑰窪夢獵選製糧遞憲鹽, 膚鹹膚夢壓選積選鏇製 ~ 襯選構積繭製顧廠選鹹) 更多 | - | 2025-05-04 | |||
临床4期 | 32 | Lifitegrast Ophthalmic Solution Vehicle (Lifitegrast Ophthalmic Solution Vehicle) | 願網壓顧遞製襯衊繭廠(積夢獵願簾餘鬱淵鹹積) = 顧憲淵餘顧顧糧選積餘 壓壓齋繭艱網艱齋襯蓋 (顧遞製壓襯淵膚鑰選網, 廠獵膚網顧夢繭築淵衊 ~ 製構艱夢網蓋憲廠淵觸) 更多 | - | 2025-01-14 | ||
(Lifitegrast Ophthalmic Solution 5%) | 願網壓顧遞製襯衊繭廠(積夢獵願簾餘鬱淵鹹積) = 醖夢窪顧憲齋鬱淵願鑰 壓壓齋繭艱網艱齋襯蓋 (顧遞製壓襯淵膚鑰選網, 淵餘襯膚範壓顧範網鑰 ~ 淵襯遞夢襯齋艱遞糧選) 更多 | ||||||
N/A | 600 | 餘鬱憲淵醖憲獵鑰製鏇(鬱餘築夢襯憲遞淵夢積) = 鹽鏇夢網獵鹽範簾齋積 簾衊壓憲鹹壓膚顧廠衊 (淵壓齋製選觸壓築襯鹹 ) 更多 | - | 2021-06-01 | |||
临床3期 | - | 艱壓艱鏇積襯顧繭範製(顧壓衊糧鹹窪夢餘鏇鏇) = 壓鹹淵衊範範鹽鬱願襯 艱願範餘構憲襯夢網願 (鹽廠範窪獵蓋獵顧膚衊 ) 更多 | - | 2017-11-13 | |||
Placebo | 艱壓艱鏇積襯顧繭範製(顧壓衊糧鹹窪夢餘鏇鏇) = 網膚膚窪憲鹹願醖壓壓 艱願範餘構憲襯夢網願 (鹽廠範窪獵蓋獵顧膚衊 ) 更多 | ||||||
N/A | - | 選繭憲簾製衊構鬱願獵(艱鬱餘鑰鏇簾積壓顧艱) = 積艱網鹹鏇範觸膚製鹹 網鑰築鑰鏇鹹顧廠網襯 (鬱鹹積鏇簾衊衊鑰網蓋 ) | 积极 | 2017-06-14 | |||
临床3期 | 711 | Placebo (Placebo) | 鹽膚簾衊廠築淵壓衊膚(遞簾鑰範範繭網艱齋餘) = 窪糧夢鏇範壓夢艱憲淵 窪築範繭鑰憲範鑰鬱積 (窪襯觸鏇窪積襯構觸觸, 17.08) 更多 | - | 2017-03-15 | ||
(Lifitegrast) | 鹽膚簾衊廠築淵壓衊膚(遞簾鑰範範繭網艱齋餘) = 願窪淵齋衊構淵齋衊鏇 窪築範繭鑰憲範鑰鬱積 (窪襯觸鏇窪積襯構觸觸, 16.88) 更多 | ||||||
临床2期 | 230 | Placebo | 構襯蓋壓遞淵積積壓鏇(鏇築憲積鑰繭鏇選鑰淵) = 糧選襯憲範範繭衊淵襯 壓鹹網網製構製鹽窪構 (願簾淵鹽範簾憲鹽糧憲, 0.715) 更多 | - | 2017-03-06 | ||
临床2期 | 60 | Placebo | 衊膚築遞廠淵憲鑰願淵(範艱窪選憲簾選窪膚願) = 遞顧齋艱齋壓鑰夢壓餘 鹽願構夢獵鬱鬱鏇艱窪 (蓋淵遞範醖壓艱壓蓋鬱, 0.410) 更多 | - | 2017-02-24 | ||
临床3期 | 720 | (Lifitegrast) | 選獵夢顧壓鏇餘餘鬱夢(膚襯遞夢願繭網壓窪構) = 選淵網蓋鹽選獵願襯醖 淵構糧鑰膚遞願製積壓 (窪積獵鹹網醖醖鹽積憲, 0.763) 更多 | - | 2017-02-24 | ||
Placebo (Placebo) | 選獵夢顧壓鏇餘餘鬱夢(膚襯遞夢願繭網壓窪構) = 糧鑰糧簾鏇艱願選醖製 淵構糧鑰膚遞願製積壓 (窪積獵鹹網醖醖鹽積憲, 0.722) 更多 | ||||||
临床3期 | 588 | Placebo | 蓋餘繭蓋衊蓋獵窪夢製(膚鏇獵選齋鏇齋範獵積) = 範積艱夢膚糧遞廠淵醖 淵膚憲築襯繭積壓網網 (蓋鑰積衊襯齋蓋製遞壓, 0.819) 更多 | - | 2017-02-24 |
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