CYCLOKAT®
Severe dry eye is a chronic lack of efficient lubrication and moisture in the eye. Its consequences range from constant irritation to ocular inflammation of the anterior tissues of the eye. The chronic dryness causes burning, itching, irritation, blurred vision, and the unpleasant sensation of a foreign body in the eye.
Background
Chronic dry eye diseases are characterized by an inflammatory response initiated on the ocular surface that has been observed in all types of dry eye. Cyclosporine A is the gold standard molecule for such cases. It has efficacy in treating the inflammation that is associated with dry eye disease, by enhancement or restoration of lacrymal gland secretion in patients suffering from this syndrome.
Nova22007 is a cationic emulsion of cyclosporine A, based on Novasorb® technology, that is expected to provide optimal efficacy. Indeed preclinical studies already demonstrated that our Nova22007 can significantly improve the absorption of Cyclosporine A in the cornea and conjunctiva. Furthermore, a Phase IIa clinical trial conducted in Sjögren patients with moderate-to-severe keratoconjunctivitis (KCS) has demonstrated good safety and tolerance of the formulation as well as promising preliminary trends toward efficacy. A phase III clinical study is ongoing in Europe and another study has been initiated in the United States during the third quarter of 2008.