STN 1013001 is accepted for review in Europe for lowering of intraocular pressure in open-angle glaucoma and ocular hypertension.- Santen
Santen Pharmaceutical Co., Ltd. announced the European Medicines Agency (EMA) has accepted for review the marketing authorization application for the use of STN 1013001 for lowering of intraocular pressure (IOP) in open-angle glaucoma and ocular hypertension.
Ocular surface disease (OSD) represents an emerging problem in the management of glaucoma, with up to 60% of glaucoma patients having dry eye. OSD is a multifactorial ocular condition that may involve tear film degradation as well as damage to the ocular surface. It negatively influences quality of life and compromises adherence to glaucoma eye drop treatment, which can influence the efficacy of the therapy.
The submission was made through the company’s local subsidiary and is based on the positive results of a PIII clinical trial carried out in Europe and Asia that evaluated the non-inferiority of STN 1013001 against latanoprost 50 ?g/mL. The eye drop’s efficacy in lowering IOP was noninferior to latanoprost at the time points of both 9 am and 4 pm at weeks four and 12.
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