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Novagali Pharma reports positive results for phase 2 trial of dry eye emulsion
EVRY, France — Novagali Pharma announced positive results from a phase 2 clinical trial of a new formulation of cyclosporine for treating dry eye, according to a press release from the company.
The drug, called Cyclokat, is a proprietary cationic emulsion that enables cyclosporine A to penetrate ocular surface tissues.
In the randomized, double-masked, vehicle-controlled trial, application of once-daily Cyclokat statistically significantly improved the signs and symptoms of moderate-to-severe dry eye when applied topically to 132 patients over a duration of 3 months.
For its dry eye trial, Novagali worked in conjunction with research and development organization Ora Inc., utilizing the company's controlled adverse environment clinical model. Efficacy was observed both before and after utilization of the controlled adverse environment clinical model, and the drug demonstrated significant efficacy for both signs and symptoms of disease at months 1 and 3.
A pivotal phase 3 trial is ongoing in Europe, and patient recruitment has been completed. The company expects to report results from the trial in the fourth quarter.