Santen New Drug Application Filing Accepted for Review in South Korea and Vietnam for the Use of STN1013001 (Cationic Emulsion of Latanoprost 50μg/mL) in Glaucoma

December 11, 2024, Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen) today announced that the Ministry of Food and Drug Safety in South Korea and the Drug Administration of Vietnam have accepted for review the New Drug Application for the use of STN1013001 for lowering intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension. South Korea and Vietnam are the first applications for this drug in Santen's Asia business region*. The drug has been marketed in 7 European countries, including Germany and Spain, under the name Catiolanze^🄬 since August 2024.

Glaucoma is a disease that causes damage to the optic nerve, leading to visual field loss. It is a major cause of visual impairment (including decreased vision and blindness) in many countries.^1,2 Since the disease is generally progressive and irreversible, early detection and treatment to control the progression are crucial. Lowering IOP is an effective means of avoiding damage to the optic nerve and is considered to be the only evidence-based means for inhibiting the progression of visual field loss caused by glaucoma. It is reported that approx. 60% of patients with open-angle glaucoma or ocular hypertension have signs and/or symptoms of ocular surface disease (OSD) in at least 1 eye,³ and OSD, 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.

STN1013001 is preservative-free latanoprost 50μg/mL presented in a lipid-containing cationic emulsion, 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.⁴ Latanoprost is a prostaglandin-related drug which reduces elevated IOP.⁵ This patented cationic emulsion technology, developed by Santen, improves the tear film lipid layer surface properties⁶ and is used as the core technology for other marketed products including in artificial tears for dry eye disease.

The application is based on a clinical package including positive results from a phase III clinical trial conducted in Europe and Asia – a non-inferiority trial of STN1013001 (cationic emulsion of latanoprost 50μg/mL) versus latanoprost 50μg/mL. The primary endpoint of IOP reduction has been defined as the non-inferiority to latanoprost 50μg/mL in IOP at 9 am and 4 pm at Week 12. In addition, both time points at week 4 also achieved the same criteria of non-inferiority as for week 12. In the secondary endpoint of OSD improvement, the superiority of STN1013001 over latanoprost was demonstrated with corneal fluorescein staining score at Week 12.⁷

“Many glaucoma patients suffer from OSD³ and would welcome new treatment options to help with this condition. We believe that we can contribute to further improving the quality of life of glaucoma patients in Asia through this drug, which is expected to protect and improve the ocular surface in addition to lowering intraocular pressure,” said Peter Sallstig, Chief Medical Officer, Santen.

References

1. Flaxman S et al. The Lancet Global Health (2017) 5: e1221–34
2. Steinmetz JD et al. The Lancet Global Health (2021) 9: e144-60
3. Leung EW et al. J Glaucoma. 2008 Aug;17(5):350-5.
4. Georgiev GA et al. Int J Mol Sci 2017 Jul 18; 18(7):1558.
5. Maria Francesca Cordeiro et al. Acta Ophthalmol 2024 Mar;102(2):e140-e155.
6. Lallemand F et al. J Drug Deliv. 2012; 2012:604204.
7. Data on file

• Asia business region: Santen's markets in Asia excluding Japan and China

About Santen
As a specialized company dedicated to eye health, Santen aspires to contribute to the realization of “Happiness with Vision” by providing products and services to patients, consumers, and medical professionals around the world. Since its establishment, and guided by its CORE PRINCIPLE, “Tenki ni sanyo suru,” Santen has been committed to helping people maintain and improve their eye health for more than 130 years. Santen is engaged in the global research and development, manufacturing, and sales and marketing of pharmaceutical products in the field of eye care, supporting the eye health of approximately 50 million people in more than 60 countries and regions worldwide. Santen’s mission is to provide essential and significant value to patients and society in the prevention, diagnosis, and treatment of eye diseases through products and services created from its expertise in the ophthalmology field and from the patient's perspective. To create a future in which as many patients as possible can lead happy and fulfilling lives, Santen is committed to doing its utmost to realize a society in which people around the world can experience “Happiness with Vision.”
For more information, please visit Santen’s website https://www.santen.com/en.

Contact
Corporate Communications
Santen Pharmaceutical Co., Ltd.
E-mail: communication@santen.com