Not a dry eye in the house

Article

Significant improvement in signs and symptoms in patients suffering from moderate-to-severe dry eye syndrome have been found following the Phase II trial of Cyclokat, the formulation of cyclosporine by French pharmaceutical ophthalmic company Novagali Pharma.

Significant improvement in signs and symptoms in patients suffering from moderate-to-severe dry eye syndrome have been found following the Phase II trial of Cyclokat, the formulation of cyclosporine by French pharmaceutical ophthalmic company Novagali Pharma.

Cyclokat is a proprietary ophthalmic emulsion enabling an optimal penetration of cyclosporine in tissues of the eye surface that benefits from Novasorb, Novagali cationic emulsion technology.

Novagali has worked with Ora Inc., a global clinical research and development organisation, in this multi-centre, random, double-mask, vehicle controlled study of 132 patients to evaluate the safety and efficacyof 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 utilising the CAE). Cyclokat demonstrated significant treatment effect on multiple efficacy variables for both signs and symptoms at month one and month three.

"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 usconfident in the success of our ongoing Phase III which outcomes are expected in Q4 2009."

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