European Commission approves Catiolanze (cationic emulsion of latanoprost 50ug/mL) to treat open-angle glaucoma and ocular hypertension

The Marketing Authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in September. The EC approval will be valid for all 27 EU member states as well as Iceland, Liechtenstein, and Norway.

The product was reviewed by 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 50ug/mL conducted in Europe and Asia. In the phase III trial, the primary endpoint which is for lowering the IOP was met as the non-inferiority of Catiolanze versus the preserved latanoprost 50ug/mL solution demonstrated at Week 12. Catiolanze determined superiority versus latanoprost in terms of improvement of Ocular Surface Disease (OSD) (secondary endpoint) in corneal fluorescein staining score at Week 12.

“A substantial number of glaucoma patients suffer from OSD5 and would welcome a treatment option for this condition. We are proud to offer this innovative cationic emulsion technology, to help improve the lives of glaucoma patients across the EMEA region and contribute to the realization of “Happiness with Vision” said Peter Sallstig, Chief Medical Officer, Santen.

Glaucoma causes damage to the optic nerve, leading to visual field loss, and it remains the leading cause of visual impairment including blindness worldwide. Since the disease is generally progressive and irreversible, early detection and treatment to control the progression are crucial, and lowering IOP is an effective means of avoiding damage to the optic nerve. It is reported that approx. 60% of patients with open-angle glaucoma or ocular hypertension have signs and/or symptoms of OSD in at least 1 eye, and OSD which is a multifactorial ocular condition that may involve tear film degradation as well as damage to the ocular surface, represents an emerging problem in the management of glaucoma.