Chauchat Laure, Guerin Camille, Rebika Hayette, Sahyoun Marwan, Collignon Nathalie
Laboratoires Horus Pharma, 22 Allée Camille Muffat, 06200, Nice, France.
Centre Hospitalier Universitaire de Clermont-Ferrand, Clermont-Ferrand, France.
Ophthalmol Ther. 2024 Oct;13(10):2661-2677. doi: 10.1007/s40123-024-01013-x. Epub 2024 Aug 12.
The purpose of this study is to assess the real-life efficacy and tolerance of a new preservative-free, surfactant-free latanoprost (PFSF-LAT) formulation.
Retrospective, multicentre, non-comparative, observational study in patients with ocular hypertension or open angle glaucoma, naïve or non-naïve to previous intraocular pressure (IOP)-lowering treatment, and treated for at least 3 months with the study eye drop. IOP for worse eye, ocular signs and symptoms, and concomitant use of artificial tears were collected at study drug initiation and at last visit under treatment. Reasons for discontinuing the study eye drop (if relevant) and investigators' satisfaction were also assessed.
In the per protocol population (103 eyes; 63 naïve, 39 switched, 1 not classified because of missing data), IOP decreased significantly (p < 0.001) from 21.6 ± 5.0 mmHg at baseline to 16.1 ± 3.5 mmHg at the end of the study (mean reduction of - 5.5 ± 4.6 mmHg; - 25.5%). IOP in naïve patients was significantly improved, with a mean reduction of 7.1 mmHg (- 30.7%), which was within expected latanoprost IOP-lowering effect. Interestingly, in previously treated patients, switching to PFSF-LAT also allowed for a further 2.9 mmHg decrease in IOP (p < 0.001). The incidence of ocular side effects at study initiation was significantly (p < 0.001) reduced from 31.1% to 11.3% in the overall population, and from 65.0% to 7.5% in switched patients. This included conjunctival hyperaemia and superficial punctate keratitis (from 42.5% to 2.5% and from 37.5% to 2.5% in switched patients, respectively). According to investigators, tolerance and efficacy of the study eye drop were satisfactory or very satisfactory in 98.1% and 83.2% of patients, respectively.
PFSF-LAT is an efficient treatment for patients with glaucoma with an improved tolerance profile. It can be considered as initial therapy in naïve patients or in patients with poor ocular tolerance to previous IOP-lowering eye drops.
本研究旨在评估一种新型无防腐剂、无表面活性剂的拉坦前列素（PFSF-LAT）制剂在实际应用中的疗效和耐受性。
对患有高眼压症或开角型青光眼的患者进行回顾性、多中心、非对照、观察性研究，这些患者既往未接受过或接受过降低眼压（IOP）治疗，且使用研究眼药水治疗至少3个月。在开始使用研究药物时以及治疗期间的最后一次随访时，收集患眼情况较差的眼睛的眼压、眼部体征和症状以及人工泪液的使用情况。还评估了停用研究眼药水的原因（如相关）和研究者的满意度。
在符合方案人群（103只眼；63只初次治疗，39只转换治疗，1只因数据缺失未分类）中，眼压从基线时的21.6±5.0 mmHg显著降低（p＜0.001）至研究结束时的16.1±3.5 mmHg（平均降低-5.5±4.6 mmHg；-25.5%）。初次治疗患者的眼压显著改善，平均降低7.1 mmHg（-30.7%），这在拉坦前列素预期的降眼压效果范围内。有趣的是，在既往接受过治疗的患者中，转换为PFSF-LAT后眼压进一步降低2.9 mmHg（p＜0.001）。在总体人群中，研究开始时眼部副作用的发生率从31.1%显著降低（p＜0.001）至11.3%，在转换治疗的患者中从65.0%降至7.5%。这包括结膜充血和浅层点状角膜炎（在转换治疗的患者中分别从42.5%降至2.5%和从37.5%降至2.5%）。根据研究者的评估，分别有98.1%和83.2%的患者对研究眼药水的耐受性和疗效满意或非常满意。
PFSF-LAT是一种对青光眼患者有效的治疗方法，耐受性有所改善。它可被视为初次治疗患者或对既往降眼压眼药水眼部耐受性差的患者的初始治疗方法。
