立他司特滴眼液治疗干眼症效果如何？

干眼病(DED)又名角结膜干燥症(KCS),是指任何原因造成的泪液质或量异常或动力学异常，导致泪膜稳定性下降,不适和眼表组织病变特征的多种疾病的总称。 It is currently the most common ocular surface disease, and the main treatment method is the use of artificial tears. ( Lifitegrast)滴眼液( Xiidra)由英国Shire制药公司研发,于2016年7月11日获得美国食品和药物管理局( FDA)批准,用于干眼病( DED)症状和体征的治疗,这是FDA批准的首个治疗干眼病的淋巴细胞功能相关抗原1( LFAH)拮抗类新药。 For the treatment of dry eye disease, Ritalast is of milestone significance. So, how effective is Ritalast eye drops in treating dry eye disease?

The effect of Ritalast eye drops in treating dry eye syndrome

Throughout the OUPS-2 trial, the ocular discomfort VAS score in the ritasilast group decreased by 26.46, while the placebo group decreased by 16.73 (score 9.67, 95% confidence interval 5.27~14.28, P<0.0001). On days 14 and 84 of the OPUS-3 trial, after comparing the average VAS scores of burning/stinging, foreign body sensation, discomfort, and photophobia, it was found that there was no significant difference in the VAS scores of these items between the ritilalast group and the placebo group; however, on day 42 of the OPUS-2 trial, compared with the placebo group, a significant improvement in the VAS scores of eye itching, foreign body sensation, and eye discomfort was observed in the ritilalast group (P<0.05).

The safety of Libalast

The tolerability and safety of Ritalast were evaluated in the randomized, double-blind, multicenter SONATA trial.试验对象需满足下述条件:年龄大于18岁干眼症患者、最好校正视力不低于0.7、 角膜荧光素染色评分至少在一个区域内不低于2、眼部干燥或者不适VAS评分大于等于40、在过去6月使用或(和)想要使用人工泪液、泪液分泌试验结果在1~10 mm。 The patients received Ritalast 5% eye drops (n=220) or placebo (n=111) twice a day for a total of 360 days.

The primary safety endpoint of the SONATA trial is the occurrence of ocular and non-ocular treatment-emergent adverse events (TEAEs). The compliance rate of the 5% Ritalast group was 84.1%, and the compliance rate of the placebo group was 81.1%, indicating that Ritalast eye drops are well tolerated when used.

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