Santen Receives European Commission Approval for Catiolanze^® (cationic emulsion of latanoprost 50μg/mL) for Lowering of Intraocular Pressure in Open-Angle Glaucoma and Ocular Hypertension

November 17, 2023, Osaka, Japan – Santen Pharmaceutical Co., Ltd. (hereinafter, Santen) announced the European Commission (EC) has approved the Marketing Authorization Application (MAA) for Catiolanze^® (cationic emulsion of latanoprost 50μg/mL, STN1013001) for lowering of intraocular pressure (IOP) in 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 innovation¹ 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. 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. ²

Catiolanze^® is a preservative-free latanoprost 50μg/mL eye drop cationic emulsion. The active substance latanoprost, a prostaglandin F2_α analogue, is a selective proteinoid FP receptor agonist which reduces the IOP by increasing the outflow of aqueous humor. 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.³ This patented cationic emulsion technology, developed by Santen, improves the tear film lipid layer surface properties⁴ and is used as the core technology for other marketed products in more than 30 countries, including artificial tears for dry eye disease.

“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.^6,7 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 ⁵, 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.

References

1. Article 3(2)b - Technical innovation of Regulation (EC) No 726/2004
2. Data on file
3. Georgiev GA et al. Surface chemistry interactions of Cationorm with films by human meibum and tear film compounds. Int J Mol Sci 2017 Jul 18; 18(7):1558. doi: 10.3390/ijms18071558
4. Lallemand F et al. Successfully improving ocular drug delivery using the cationic nanoemulsion, Novasorb. J Drug Deliv. 2012; 2012:604204. doi: 10.1155/2012/604204. Epub 2012 Feb 27
5. Leung EW, Medeiros FA, Weinreb RN. Prevalence of ocular surface disease in glaucoma patients. J Glaucoma. 2008 Aug;17(5):350-5. doi: 10.1097/IJG.0b013e31815c5f4f.
6. Flaxman S et al. Global causes of blindness and distance vision impairment 1990–2020: a systematic review and meta-analysis. The Lancet Global Health (2017) 5: e1221–34
7. Steinmetz JD et al. Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study. The Lancet Global Health (2021) 9: e144-60

About Santen
As a specialized company dedicated to eye health Santen carries out research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices, and its products now reach patients in over 60 countries and regions. Towards realizing “WORLD VISION” (Happiness with Vision), the world Santen ultimately aspires to achieve, Santen aims to reduce the social and economic opportunity loss of people around the world caused by eye diseases and defects. With scientific knowledge and organizational capabilities nurtured over a 130-year history, Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s website (https://www.santen.com/en).

Contact
Corporate Communications
Email: communication@santen.com