Changing Paradigms of Treating Severe Keratitis in Dry Eye Disease

Abstract

These proceedings are based on a symposium, presented at the European Society of Ophthalmology 2015 Congress in Vienna, Austria on 8 June 2015. The symposium was arranged by Santen to bring together leaders in ophthalmology with the objective of exploring advances in the treatment of severe keratitis in dry eye disease (DED). DED is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance and tear instability with potential damage to the ocular surface. Abnormalities at the ocular surface can affect all tear dynamic components, resulting in a vicious cycle that reinforces/sustains DED. Ciclosporin (CsA) is thought to exert an anti-inflammatory effect on ocular surface cells. This compound should be in the near future one of the principal advances in the treatment of DED for blocking the vicious cycle of the disease. Extensive formulation development work has led to the availability of a well-tolerated, stable cationic nanoemulsion, designated as Novasorb® technology. This technology has been used in the first European approved CsA 1 mg/mL eye drops emulsion (Ikervis®) for the treatment of severe keratitis in adult patients with DED, which has not improved despite treatment with tear substitutes. Clinical trials involving over 900 patients have demonstrated a good safety and tolerability profile and significant clinical efficacy of this formulation with a once-daily dosing regimen. CsA 1 mg/mL eye drops were evaluated in the pivotal phase III SANSIKA study, which confirmed the positive benefit–risk profile of CsA 1 mg/mL eye drops for the treatment of severe keratitis in DED. An assessment of ocular surface health requires: listening to the patient, the use of simple diagnostic tools, an expertise in examination, including use of microscopy, and an up-to-date knowledge of current models of DED.