The European Commission (EC) has approved the Marketing Authorization Application (MAA) for Catiolanze (cationic emulsion of latanoprost 50μg/mL) for lowering of intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension. 

This 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 centralised 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, randomised, controlled non-inferiority study of cationic emulsion of latanoprost 50μg/mL versus preserved latanoprost 50μg/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 50μg/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.

Catiolanze is a preservative-free latanoprost 50μg/mL eye drop cationic emulsion. The active substance latanoprost, a prostaglandin F2α analogue, is a selective proteinoid FP receptor agonist which reduces the IOP by increasing the outflow of aqueous humour. This formulation uses a technology in which the positively-charged emulsion droplets are attracted onto the negatively-charged ocular surface to increase its spreading and residence time on the ocular surface. 

This patented cationic emulsion technology, developed by Santen, improves the tear film lipid layer surface properties and is used as the core technology for other marketed products in more than 30 countries, including artificial tears for dry eye disease.

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 approximately 60% of patients with open-angle glaucoma or ocular hypertension have signs and/or symptoms of OSD in at least one 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.

For further information, see www.santen.com/en