EC approval for Santen's Catiolanze

Following a positive recommendation from the European Medicines Agency’s (EMA) human medicines committee CHMP in September, Japanese ophthalmology firm Santen Pharmaceutical (TYO: 4536) has now received marketing authorization from the European Commission for Catiolanze (cationic emulsion of latanoprost 50μg/mL, STN1013001).

The drug is indicated for lowering of intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. The EC approval will be valid for all 27 European Union member states as well as Iceland, Liechtenstein and Norway.

Santen said the product was reviewed by the EMA under centralized procedure based on technical innovation and this approval was based on data from a clinical package including positive results from a phase III clinical trial, single-masked, randomized, controlled non-inferiority study of Catiolanze versus latanoprost 50μg/mL conducted in Europe and Asia.