Purpose

To comprehensively review the efficacy and safety of OC-01 varenicline nasal spray versus vehicle nasal spray (VNS) in the treatment in dry eye disease (DED).

Methods

A systematic review that included full-length randomized controlled studies (RCTs), as well as post hoc analyses of RCTs reporting new findings on OC-01 VNS treatment in three databases, PubMed, Scopus and Web of Science, was performed according to the PRISMA statement. The search period included studies published between December 2021 and September 2023. The Cochrane risk of bias tool was used to analyze the quality of the studies selected.

Results

A total of 8 studies were included in this systematic review. OC-01 VNS treatment achieved higher improvement than vehicle in all reported variables. The mean differences between both groups were in favor of OC-01 VNS treatment and were as follow: eye dryness score base on a visual analogue scale (EDS-VAS) of −7.5 ± 2.2 points [-11.6 to −5.6], Schirmer test (ST) with anesthesia of 6.6 ± 2.3 mm [4.9 to 11.8] and total corneal fluorescein staining (tCFS) of −1.2 ± 0.01 points [-1.2 to −1.1]. Similar improvements were reported with OC-01 VNS 0.03 mg and 0.06 mg. Adverse events (AEs) were 15.5 ± 19.4 % [-13 to 80.5] higher in the OC-01 VNS group with an overall adherence > 93 %.

Conclusions

OC-01 VNS improves dry eye symptoms and signs with a satisfactory tolerability. Therefore, OC-01 VNS seems to be a safe and effective treatment that could be recommended in patients with DED. This new treatment could be particularly useful in those patients who have difficulties with the administration of traditional topical therapies.

中文翻译：

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双侧 OC-01（伐尼克兰溶液）鼻喷雾剂缓解干眼病体征和症状的功效：系统评价

目的

全面评价 OC-01 伐尼克兰鼻喷雾剂与载体鼻喷雾剂 (VNS) 治疗干眼病 (DED) 的疗效和安全性。

方法

根据 PRISMA 进行了系统评价，其中包括完整的随机对照研究 (RCT) 以及在 PubMed、Scopus 和 Web of Science 三个数据库中报告 OC-01 VNS 治疗新发现的 RCT 事后分析陈述。检索期包括 2021 年 12 月至 2023 年 9 月期间发表的研究。Cochrane 偏倚风险工具用于分析所选研究的质量。

结果

本次系统评价共纳入 8 项研究。OC-01 VNS 治疗在所有报告的变量中均取得了比媒介物更高的改善。两组之间的平均差异有利于 OC-01 VNS 治疗，具体如下：基于视觉模拟量表 (EDS-VAS) 的眼干评分为 -7.5 ± 2.2 分 [-11.6 至 -5.6]，Schirmer 检验(ST) 麻醉为 6.6 ± 2.3 mm [4.9 至 11.8]，总角膜荧光素染色 (tCFS) 为 -1.2 ± 0.01 点 [-1.2 至 -1.1]。据报道，OC-01 VNS 0.03 mg 和 0.06 mg 也有类似的改善。OC-01 VNS 组的不良事件 (AE) 增加了 15.5 ± 19.4 % [-13 至 80.5]，总体依从性 > 93 %。

结论

OC-01 VNS 可改善干眼症状和体征，且具有令人满意的耐受性。因此，OC-01 VNS 似乎是一种安全有效的治疗方法，可推荐用于 DED 患者。这种新疗法对于那些难以接受传统局部疗法的患者特别有用。