Results of a Multicenter, Randomized, Double-Masked, Placebo-Controlled Clinical Study of the Efficacy and Safety of Visomitin Eye Drops in Patients with Dry Eye Syndrome

Abstract

IntroductionThis article presents the results of an international, multicenter, randomized, double-masked, placebo-controlled clinical study of Visomitin (Mitotech LLC, Moscow, Russian Federation) eye drops in patients with dry eye syndrome (DES). Visomitin is the first registered (in Russia) drug with a mitochondria-targeted antioxidant (SkQ1) as the active ingredient.MethodsIn this multicenter (10 sites) study of 240 subjects with DES, study drug (Visomitin or placebo) was self-administered three times daily (TID) for 6 weeks, followed by a 6-week follow-up period. Seven in-office study visits occurred every 2 weeks during both the treatment and follow-up periods. Efficacy measures included Schirmer’s test, tear break-up time, fluorescein staining, meniscus height, and visual acuity. Safety measures included adverse events, slit lamp biomicroscopy, tonometry, blood pressure, and heart rate. Tolerability was also evaluated.ResultsThis clinical study showed the effectiveness of Visomitin eye drops in the treatment of signs and symptoms of DES compared with placebo. The study showed that a 6-week course of TID topical instillation of Visomitin significantly improved the functional state of the cornea; Visomitin increased tear film stability and reduced corneal damage. Significant reduction of dry eye symptoms (such as dryness, burning, grittiness, and blurred vision) was also observed.ConclusionBased on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage.FundingMitotech LLC.

Mitochondria-Targeted Triphenylphosphonium-Based Compounds: Syntheses, Mechanisms of Action, and Therapeutic and Diagnostic Applications

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NETosis: Molecular Mechanisms, Role in Physiology and Pathology

“…Dry eye syndrome, which often occurs as a manifestation of the “graft versus host” reaction after bone marrow transplantation [ 77 ], and Sjogren’s autoimmune syndrome [ 78 ] are also characterized by accumulation of NETs in the lacrimal fluid. Interestingly, the mitochondria-targeted antioxidant SkQ1 (an acting component of the eye drops “Visomitin”) was proven to be highly effective in the treatment of dry eye syndrome of various etiologies [ 79 ]. It can be assumed that this effect of SkQ1 is partly related to the suppression of NETosis described in our study [ 16 ].…”

Mitochondrial Dysfunctions May Be One of the Major Causative Factors Underlying Detrimental Effects of Benzalkonium Chloride

“…Damaged action of BAC on rat liver mitochondria and yeast cells associated with its prooxidant effect can be considerably diminished by SkQ1, a mitochondria-addressed (transported exclusively in mitochondria) antioxidant (Figures 7 and 8). These promising results may be considered as a rationale for advisability of using mitochondrial-targeted antioxidants in ophthalmic formulations containing BAC and, more generally, for mitigating diseases related to oxidative stress and mitochondrial dysfunctions [70][71][72][73][74].…”