Cyclosporin (0.09%) Ophthalmic Solution for the Treatment of Dry Eye Disease – A Narrative Review

PURPOSE: Dry eye disease (DED) is a multifactorial ocular surface disorder characterized by tear film instability, hyperosmolarity, and inflammation. Although the exact etiology may vary between patients, inflammation remains a central pathogenic mechanism. Key inflammatory pathways in DED include T-cell activation and the upregulation of cytokines such as interleukin-1 (IL-1), tumor necrosis factor-alpha (TNF-α), and matrix metalloproteinases (MMPs). Cyclosporine A (CsA) is an immunomodulatory agent that reduces ocular surface inflammation by inhibiting calcineurin, thereby suppressing T-cell activation. METHODS: This narrative review summarizes the available evidence on the role of topical CsA 0.09% in DED, including its formulation characteristics, mechanism of action, efficacy, safety, and tolerability. Relevant preclinical and clinical studies of the aqueous nanomicellar formulation of CsA 0.09% (OTX-101 0.09%) were reviewed. RESULTS: Conventional ophthalmic preparations of CsA are oil-based or oil-in-water emulsions, which have several limitations, including poor ocular tolerability and a slow onset of efficacy. An aqueous nanomicellar formulation of CsA 0.09% (OTX-101 0.09%) has been approved by the US Food and Drug Administration and the European Medicines Agency. It is widely used for treating DED, enhancing ocular bioavailability while improving ocular tolerability. Clinical studies have demonstrated that nanomicellar CsA 0.09% therapy significantly improves both signs and symptoms of DED, supporting its utility as an effective and well-tolerated treatment option. CONCLUSION: Nanomicellar CsA 0.09% therapy significantly improves both signs and symptoms of DED, supporting its utility as an effective and well-tolerated treatment option.