Drug news: Novagali's Cyclokat completes Phase II

Novagali Pharma Completed a New Phase II With Cyclokat(R) in Dry Eye

EVRY, France | April 15, 2009 | Novagali Pharma, a French pharmaceutical ophthalmic company, today announces successful completion of a new Phase II clinical study with Cyclokat®, its formulation of Cyclosporine. The results demonstrate statistically significant improvement with signs and symptoms in patients suffering from moderate-to-severe dry eye syndrome.

For this dry eye clinical trial, Novagali worked with Ora, Inc., a leading global clinical research and development organization located in Andover, MA, USA. This phase II, multi-centre, randomized, double-masked, vehicle controlled study of 132 patients evaluated the safety and efficacy of Cyclokat® applied once-a-day over three months. Ora's proprietary Controlled Adverse Environment (CAE) clinical model was used in this study conducted in the US.

Efficacy was observed post-CAE as well as pre-CAE (environmental comparisons following selection and enrollment of patients utilizing the CAE). Cyclokat® demonstrated significant treatment effect on multiple efficacy variables for both signs and symptoms at Month 1 and Month 3. . These findings confirm potential clinical interest of Cyclokat® for the treatment of dry eye syndrome.

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