Cyclosporine for dry eye shows significant improvement in symptoms, according to phase II study

Evry, France-Phase II of a clinical study examining a formulation of cyclosporine (Cyclokat, Novagali Pharma) has been completed, and results demonstrate statistically significant improvement with signs and symptoms in patients suffering from moderate-to-severe dry eye syndrome.

A French pharmaceutical company (Novagali Pharma) worked with a research and development organization in Andover, MA (Ora Inc.) for the clinical trial. The multicenter, randomized, double-masked, vehicle controlled study of 132 patients evaluated the safety and efficacy of the formulation applied once-a-day over 3 months. The Controlled Adverse Environment (CAE) clinical model (Ora Inc.) was used in this study conducted in the United States.

Efficacy was observed post-CAE as well as pre-CAE (environmental comparisons following selection and enrollment of patients utilizing the CAE). The formulation demonstrated significant treatment effect on multiple efficacy variables for both signs and symptoms at Month 1 and Month 3.

"We are very enthusiastic about the results of this new trial demonstrating efficacy on both dry eye signs and symptoms" said Jerome Martinez, chief executive officer of Novagali "These are promising results, which make us confident in the success of our ongoing phase III which outcomes are expected 4Q2009."

A pivotal phase III trial is ongoing in Europe and patient recruitment has been completed.