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Philippe Daull, Laurence Feraille, Stefano Barabino, Jean-Sebastien Garrigue; Efficacy evaluation of a cationic emulsion of cyclosporine in a mouse model of dry eye. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4468. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
Dry eye disease is a complex, multifactorial pathology characterized by corneal epithelium lesions and inflammation. The severity of these assaults is often correlated to the severity of the disease. The aim of the present study was to evaluate the efficacy of a cationic emulsion of cyclosporine (CsA) in a mouse model that mimics severe dry eye.
Eight to 12-week-old female C57BL6 mice with tail patches of scopolamine (replaced every other days) were housed in controlled environment chambers (CEC) to induce dry eye. At day three, following dry eye confirmation by corneal fluorescein staining (CFS, score 0-15) and phenol red thread (PRT) lacrimation test, the mice (n=10/gp) were either treated 3 times a day in both eyes with: drug-free cationic emulsion, a 0.1% CsA-loaded cationic emulsion, and 1% methylprednisolone (positive control), or left untreated. Aqueous tear production, CFS score, Goblet cell density in the conjunctiva and CD11b+ count in flat mounted cornea were evaluated at the end of the treatment period (at day 10).
The PRT lacrimation test confirmed the scopolamine-induced decrease in aqueous production by the lacrimal gland. After 7 days of treatment, the CFS score was reduced by 59% with the 0.1% CsA-loaded cationic emulsion (CFS score at D3 before treatment: 12.1 ± 1.7; vs D10: 5.5 ± 2.0). The beneficial effect of the cationic emulsion vehicle itself on keratitis was also clearly evidenced by its better performance over the 1% methylprednisolone eye drop, -36%, vs. -28%, respectively. The Goblet cell density and the tear production were not markedly improved by any treatment in this model. A reduction in inflammatory markers was also observed for the 0.1% CsA-loaded cationic emulsion when compared to the untreated group.
This study indicates that the cationic emulsion of cyclosporine (0.1%) was a very effective formulation for the management of corneal epithelium lesions in a severe dry eye disease mouse model. In addition, it performed better than a potent glucocorticosteroid (1% methylprednisolone). This cationic emulsion of cyclosporine (0.1%) represents a promising new treatment strategy for the management of the signs of dry eye.
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