Initial hypotensive therapy of primary glaucoma with the domestic latanoprost generic: efficacy and safety

Abstract

Purpose: a comparative study of the efficacy and safety of the Latanoprost-Optic drug and the original latanoprost drug administered to previously untreated patients with primary open-angle glaucoma (POAG). Material and methods. A double-blind, randomized, parallel-group study involved 60 patients (70 eyes) with newly diagnosed POAG, who were randomly divided into 2 groups of equal size. The patients of the main group (34 eyes) received Latanoprost-Optic, whilst the control group received the original preparation of latanoprost, 1 instillation in the evening. The reference points were the values of intraocular pressure, visual acuity, perimetric indices (standard deviation, standard deviation pattern), the average thickness of the retinal nerve fiber layer, the minimum width of the neuroretinal girdle, the thickness of the retinal nerve fiber layer in the macula, the thickness of the ganglion cell layer in the macula, the thickness of the inner plexiform layer, and the safety (adverse events). The observation period was 12 weeks. Results. After 2 weeks, both groups showed a statistically significant decrease in intraocular pressure, which remained stable after 6 and 12 weeks. The average decrease in intraocular pressure of those receiving Latanoprost-Optic was 30% and at no control point a statistically significant difference from the original drug was revealed. A positive dynamic of visual acuity, static perimetry indices and optical coherence tomography was registered, showing n significant intergroup differences. This may indicate that the drugs have an indirect neuroprotective effect. The adverse events included discomfort and redness of the bulbar conjunctiva, which were recorded in 7 out of 30 patients in the study group and in 6 out of 30 patients in the control group. All of them were mild and completely reversible. No serious or systemic adverse events were reported. Conclusion. Latanoprost-Optic has an efficacy comparable to that of the original latanoprost drug and has a comparable favorable safety profile.