Date: 2011-04-05
Type of information:
phase: 3
Announcement: enrollment of the first patients
Company: Novagali Pharma (France)
Product: Cyclokat® (cyclosporine ophthalmic formulation)
Action mechanism: This proprietary cationic emulsion employs the Novasorb® technology that optimizes the absorption of cyclosporine in tissues of the eye surface which makes once-a-day dosing possible.
Disease: dry eye disease
Therapeutic area: Ophtalmological diseases
Country: Europe, USA
Trial details: The Sansika® study is a multicenter, randomized, double-masked, two parallel arms, vehicle-controlled, 6 month phase III trial of Cyclokat® in patients with severe Dry Eye Disease with a 6 month open label treatment safety follow-up period. Approximately 250 patients will be enrolled across 6 European Union member states. This pivotal phase III clinical trial follows two phase II studies performed in Europe and in the US and, the Siccanove study, the first European phase III study of Cyclokat® conducted in patients with moderate to severe Dry Eye Disease.
Latest
news: Novagali Pharma has announced enrollment of the first patients in Sansika study, the European multinational confirmatory pivotal Phase III study of Cyclokat® in patients with severe dry eye disease. The company received a positive Scientific Advice from the European Medicines Agency (EMA) regarding the final steps in the development of Cyclokat® last December.
