CHMP recommends Catiolanze for the reduction of elevated intraocular pressure (IOP) in patients with open angle glaucoma or ocular hypertension
On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Catiolanze, intended for the reduction of elevated intraocular pressure (IOP) in adults with open angle glaucoma or ocular hypertension and in children from 4 years and adolescents with elevated IOP and paediatric glaucoma. The applicant for this medicinal product is Santen Oy.
The benefit of Catiolanze is a reduction of IOP in line with that observed for its comparator Xalatan, as shown in a phase III randomised clinical trial. The most common side effects were ocular and conjunctival hyperaemia and abnormal sensation in the eye.
Catiolanze will be available as a 50 µg/ml eye drop emulsion. The active substance of Catiolanze is latanoprost, a prostaglandin analogue that is believed to reduce IOP by increasing uveoscleral outflow. Catiolanze is approved through a hybrid application with Xalatan as the reference medicinal product which has been authorised in the EU since 1996. Catiolanze contains the same active substance as Xalatan, but is formulated in an emulsion formulation without benzalkonium chloride (BAK). Catiolanze contains the excipient cetalkonium chloride (CKC).
Related news and insights
Ocuphire Pharma, Inc. and Viatris Inc. announced that the FDA has approved Ryzumvi (phentolamine ophthalmic solution) 0.75% (formerly Nyxol) for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents
Verona Pharma plc announces the FDA has accepted for review the Company’s New Drug Application (“NDA”) seeking approval of ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease (“COPD”)