1Federal State Budgetary Educational Institution of Higher Education North-Western State Medical University named after I.I. Mechnikov, Ministry of Health of the Russian Federation, 41 Kirochnaya St., Saint Petersburg, 195067, Russia
2Saint Petersburg State Budgetary Healthcare Institution City Polyclinic No. 94 of the Nevsky District, 24 Tovarishchesky Ave., Lit. A, Saint Petersburg, 193231, Russia
3Saint Petersburg State Budgetary Healthcare Institution City Polyclinic No. 23, 17 Kosinova St., Saint Petersburg, 198095, Russia
4Federal State Budgetary Educational Institution of Higher Education First Saint Petersburg State Medical University named after Academician I.P. Pavlov, Ministry of Health of the Russian Federation, 6-8 Lev Tolstoy St., Saint Petersburg, 197022, Russia
Brief summary
Purpose of the study: to conduct a comparative analysis of the efficacy and safety of Russian generic latanoprost formulations in the treatment of primary open-angle glaucoma (POAG).
Materials and Methods.
The study included patients with stage I and II POAG (59 patients, 109 eyes) receiving prostaglandin analogues. The patients were divided into three groups: group 1: patients treated with the Russian generic «Latanoprost-Optic» (LEKKO) - 16 patients (31 eyes); group 2: patients treated with the Russian generic «Trilactan» (Solopharm) - 19 patients (34 eyes); group 3: patients treated with the original drug «Xalatan» (Pfizer, Belgium) - 24 patients (44 eyes).
A retrospective analysis of outpatient medical records was performed, including best-corrected visual acuity, static perimetry data (Pericom automated perimeter), intraocular pressure measured by Maklakov tonometry, and optical coherence tomography of the optic nerve head (Huvitz Hoct-1F tomograph). The follow-up period was 12 months. In addition, a prospective assessment of drug tolerability wasconducted using a specially designed questionnaire.
Results.
Comparative analysis demonstrated a statistically significant reduction in intraocular pressure in all three groups (p < 0,05), with a mean decrease of approximately 8 mm Hg, which was maintained throughout the entire follow-up period. The safety profiles of the generic drugs were comparable to that of the original medication. The use of latanoprost generics was associated with adverse effects generally characteristic of prostaglandin analogues.
Conclusion.
Russian-produced latanoprost generics (Latanoprost-Optic and Trilactan) are not inferior to the original prostaglandin analogue in terms of efficacy and safety and maybe considered an optimal therapeutic alternative.