Novagali Pharma, a France-based ophthalmic pharmaceutical company, has successfully completed 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, a clinical R&D organization located in Andover, Massachusetts, US.
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 controlled adverse environment (CAE) clinical model was used in this study conducted in the US.
According to the company, efficacy was observed post-CAE as well as pre-CAE. Cyclokat has demonstrated significant treatment effect on multiple efficacy variables for both signs and symptoms at month one and month three. These findings confirm potential clinical interest of Cyclokat for the treatment of dry eye syndrome. A pivotal Phase III trial is ongoing in Europe and patient recruitment has been already completed.
Jerome Martinez, CEO of Novagali, said: We are very enthusiastic about the results of this new trial demonstrating efficacy on both dry eye signs and symptoms. These are promising results which make us confident in the success of our ongoing Phase III which outcomes are expected in the fourth quarter of 2009.