Effectiveness and safety of hypotensive therapy of primary glaucoma with a Russian generic fixed combination of dorzolamide and timolol

Purpose: a comparative study of the efficacy and safety of the generic drug Dorzial Plus, an analogue of the original reference drug Cosopt®, in patients with primary open-angle glaucoma (POAG).

Material and methods. The study involved 80 patients of both sexes aged 55–75 with newly diagnosed POAG of the initial and advanced stages with uncompensated intraocular pressure (IOP), of which 40 patients (study group) received Dorzial Plus and 40 patients (comparison group) received the reference drug (Cosopt®). Hypotensive efficacy of the drugs in both groups was assessed using a portable ophthalmic tonometer Icare PRO (Finland) by reducing IOP from the initial level after 1 week, 1 month and 3 months of treatment.

Results. In both groups, the screening showed comparable average IOP values: 26.7 ± 3.2 mm Hg in the reference drug group and 27.4 ± 2.8 mm Hg in the Dorzial Plus group. After 1 week of therapy with Cosopt, IOP showed a significant decrease of 33% (reduction to 17.9 ± 3.2 mm Hg), while the group receiving Dorzial Plus demonstrated a 31% decrease (reduction to 18.9 ± 1.7 mm Hg). After 1 month of the instillation regimen, a slight increase in P0 (of about 3%) was recorded in both groups (increase to 18.7 ± 2.3 and 19.7 ± 2.0 mm Hg, respectively). By the end of the 3 months’ follow-up period, IOP decrease level with respect to the baseline remained practically the same, amounting to 30 and 29% (up to 18.6 ± 1.8 and 19.5 ± 2.3 mm Hg), respectively. The state of the ocular surface showed a slightly negative dynamics of tear film rupture time and OSDI index in the reference drug group, which could be observed throughout 3 months of therapy. In the study group, therapy with preservative-free drug containing a moisturizing agent (sodium hyaluronate) revealed a significantly changed OSDI index, manifesting itself in restructured severity of the evaluated features.

Conclusion. Dorzial Plus reduces IOP in POAG patients by an average of 30% of the baseline, so that its hypotensive efficacy is comparable to the original fixed combination Cosopt. The tolerability analysis of the study drug demonstrates a significant positive dynamic of the state of the ocular surface as soon as 3 months after therapy start.

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