立他司特能治疗干眼症吗?
能治疗干眼症,该药是 FDA批准的首个治疗干眼病的淋巴细胞功能相关抗原1( LFA-1)拮抗类新药。
About Ritalast
Lifitegrast was designed and developed by SARCODE Bioscience. In 2013, SARCODE Bioscience was acquired by Shire. Shire conducted subsequent development of lifitegrast and was approved by the US FDA for marketing in July 2016 under the trade name Xiidra.
Litalast is the first new lymphocyte function-associated antigen 1 (LFA-1) antagonist drug approved by the FDA for the treatment of dry eye disease. It is also the only drug in the U.S. market that is prescribed as eye drops.目前在全球上市的国家有美国、加拿大和澳大利亚,欧盟EMA正在审评中。另外,该药物并未进口于中国销售,所以在中国具有比较好的发展前景。
The role of Libalast
Ritalast is a new small molecule integrin protein antagonist whose structure is similar to the antigenic determinant of ICAM-1. It works by competitively antagonizing the binding process of ICAM-1 and LFA-1, thereby blocking T cell-mediated inflammatory responses.
Ritalast clinical trial
在OPUS-2中,立他司特组和安慰剂组的角膜荧光素染色评分下降值分别为1.62 and 1.49 (corresponding efficacy score is 0.14, 95% confidence interval is -1.16 to 0.44), and the reduction values of conjunctival lissamine staining scores in the ritasilast group and placebo group were 0.25 and 0.27 respectively (corresponding efficacy score is 0.02, 95% confidence interval is -0.14 to 0.10).
On Day 42, the visual analogue scale (VAS) for dry eyes decreased by 12.6 points in the OPUS-1 5% ritasilast group and by 9.1 points in the placebo group (treatment effect score 4.2, 95% confidence interval 0 to 8.5).
In the OPUS-2 trial, on day 14, the efficacy score was 6.67 (95% confidence interval 3.05-10.30, P=0.000 3); on day 42, the efficacy score was 10.63 (95% confidence interval 6.71-14.55, P<0.000 1).
In the OPUS-3 trial, the VAS treatment effect score for dry eyes was significant. On the 14th day, the efficacy score was 7.85 (95% confidence interval: 4.33-11.37, P<0.000 1); on the 42nd day, the efficacy score was 9.32 (95% confidence interval: 5.44-13.20, P<0.0001).
Summary
From the above experimental data, it can be seen that in terms of corneal fluorescein staining score, conjunctival lissamine staining score, VAS score, and VFSS score, the Ritalast group was better than the placebo group, indicating that the drug has obvious efficacy and can be used for the treatment of dry eye syndrome.
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