Abstract

Aims/Purpose: This study aims to assess clinical effectiveness, outcome and safety of long‐term topical Cyclosporine A 0.1% Cationic Emulsion (CsA 0.1% CE; Ikervis®) treatment in patients with dry eye disease.Methods: Retrospective chart review of 55 patients (110 eyes) with dry eye disease and severe keratitis treated with Ikervis® since 2016 for at least 12 months without interruption was performed. Study outcomes were median change from baseline in corneal fluorescein staining (CFS, Oxford Grade Scale) score, clinical outcome, treatment discontinuation reason, ocular symptom severity and adverse events (AEs) during long follow‐up.Results: The mean age of patients was 65.96 ± 1.9 years, 81.8% women and 18.2% men. The mean follow‐up was 33.8 ± 19.1 (12–80) months. 43.6% eyes had grade III of CFS at baseline and 4.5% had grade I of CFS at the last follow up. The median CFS score reduced from 2 (1–3) at baseline to 0 (0–1) at the last follow up and this reduction was statistically significant (p < 0.001) from the fourth week. Clinical outcome was defined as active/worsening in 1.8%, stabilization in 14.5%, improvement in 69.1% and resolution in 14.5% of the cases. 65.5% of the patients have continued the treatment without interruption during the whole follow‐up, the treatment discontinuation in 35.5% of the cases were due to improvement (14.5%), AEs (5.5%), patient decision (5.5%), treatment failure (3.6%), other reason (5.5%). Ocular symptom severity was significantly reduced from baseline during the follow up (p < 0.001). In 27.3% cases treatment‐related AEs were reported, most of them (64.7%) were mild.Conclusions: This study shows a long‐term clinical effectiveness and persistence of the topical CsA 0.1% CE treatment in patients with dry eye disease. The significantly reduction of the dry eye symptoms severity from the fourth week of the initiated Ikervis® treatment sustains for a long follow up, and thus definitely improves the quality of life of patients.Reference1. Geerling G, Hamada S, Trocmé S, Ræder S, Chen X, Fassari C, Lanzl I; PERSPECTIVE study group. Real‐World Effectiveness, Tolerability and Safety of Cyclosporine A 0.1% Cationic Emulsion in Severe Keratitis and Dry Eye Treatment. Ophthalmol Ther 2022; 11(3): 1101–1117. doi: 10.1007/s40123‐022‐00487‐x.

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