Santen applies for manufacturing and marketing approval in Japan for STN1012600 ophthalmic solution (sepetaprost ophthalmic solution), a treatment for glaucoma and ocular hypertension with a novel mechanism of action for lowering intraocular pressure

Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has filed an application for manufacturing and marketing approval of STN1012600 (generic name: sepetaprost) in Japan. The application was filed on September 26, 2024. STN1012600 is a dual agonist of the FP and EP3 receptors, using as its active ingredient sepetaprost, a compound originally developed and manufactured by Ono Pharmaceutical Co., Ltd. STN1012600 is a prostaglandin derivative for the treatment of glaucoma and ocular hypertension that contains 0.002% sepetaprost and has a novel mechanism of action for lowering intraocular pressure.

Glaucoma is a disease in which the optic nerve is damaged by increased intraocular pressure and other factors. Without appropriate treatment, the condition can, in the worst cases, lead to blindness. It remains the leading disease-related cause of visual impairment (vision loss and blindness) in Japan. ¹ Because glaucoma-related optical nerve damage and visual field loss are fundamentally progressive and irreversible, it is crucial to control progression of the condition through early diagnosis and the provision of treatment to lower the intraocular pressure, which is an effective means to reduce the progression of glaucoma. Effective pharmaceutical treatments for glaucoma include FP receptor agonists, EP2 receptor agonists, and sympathetic beta receptor blockers. However, if the treatment with a single pharmaceutical agent fails to produce a sufficient decrease in intraocular pressure, medication change or concomitant treatment using a product with a different mechanism of action is recommended.² However, associated with this approach is the issue of poor adherence resulting from an increase in the number of drugs that must be taken. Other issues include lack of sufficient treatment options for patients with pharmaceutical resistance and the inability of pharmaceutical therapies to achieve sufficient intraocular pressure reduction at night. ^3,4

The efficacy of this product was confirmed through a Phase III clinical trial (multicenter, observer-masked, parallel-group, randomized trial) undertaken in Japan. The trial demonstrated the intraocular pressure lowering effect of once-daily administration of 0.002% STN1012600 ophthalmic solution was non-inferior to the administration of 0.005% latanoprost ophthalmic solution, currently one of the first-line treatments for glaucoma. In addition, in a long-term clinical trial conducted in Japan (multicenter, open-label, parallel group, randomized trial), 0.002% STN1012600 ophthalmic solution was shown to control intraocular pressure with once-daily administration over one-year. From safety perspective, administration of the product was found to cause, with a similar frequency, characteristics that are also observed following the administration of FP receptor agonists, such as conjunctival hyperemia and changes to the eyelashes and eyelids. No critical systemic adverse drug reactions were observed.

Santen’s Chief Medical Officer Peter Sallstig commented: “Glaucoma is the leading cause of blindness in Japan¹, and many patients are undergoing drug therapy. However, in many cases treatment with a single drug does not produce a sufficient reduction in intraocular pressure, and therefore additional therapies that use a different mechanism of action or combination drugs are often required to achieve target intraocular pressure. As a result, there is a demand for new pharmaceutical treatments that address the problems of reduced adherence and adverse drug reactions risk that result from the use of multiple products. Santen has positioned glaucoma as one of the most important disease areas to address, and over the years has promoted the development of glaucoma treatments and solutions to help with treatment adherence. In submitting an application for STN1012600, which has a novel mechanism of action, we are extremely proud to be pursuing the possibility of providing a new first-line treatment that addresses the unmet needs of glaucoma patients.”

As a specialized company dedicated to eye health, Santen seeks to contribute to the improved quality of life of glaucoma patients in Japan by providing more treatment options to the medical community.

Glaucoma
Glaucoma is a major cause of irreversible blindness worldwide. In 2013, an estimated 64.3 million people lived with glaucoma. That number is expected to reach 111.8 million in 2040. ⁵ In Japan, glaucoma is the leading cause of blindness. ¹ Among Japanese people aged 40 and over, 5.0% have glaucoma (primary open-angle glaucoma 3.9%, primary angle-closure glaucoma 0.6%, secondary glaucoma 0.5%) and 0.8% have ocular hypertension. ^6,7 The percentage of people living with glaucoma increases with age and as the average age of the Japanese population is rising, the proportion of people in Japan with the condition is also expected to increase, making early diagnosis and treatment ever more important.

References

1. Matoba R, Morimoto N, Kawasaki R, et al. A nationwide survey of newly certified visually impaired individuals in Japan for the fiscal year 2019: impact of the revision of criteria for visual impairment certification. Jpn J Ophthalmol. 2023;67(3), 346–352.
2. Glaucoma treatment guidelines (5th edition). Acta Societatis Ophthalmologicae Japonicae. 2022;126:85-177.
3. Ikeda Y, Mori K, Ishibashi T, Naruse S, Nakajima N, Kinoshita S. Latanoprost nonresponders with open-angle glaucoma in the Japanese population. Jpn J Ophthalmol. 2006;50:153-7.
4. Nakamoto K, Current options for and limitations of interocular pressure lowering treatments for glaucoma, Journal of Nippon Medical School. 2023;19(2):156-63.
5. Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014;121:2081-90.
6. Iwase A, Suzuki Y, Araie M, Yamamoto T, Abe H, Shirato S, et al; Tajimi Study Group, Japan Glaucoma Society. The prevalence of primary open-angle glaucoma in Japanese: the Tajimi study. Ophthalmology. 2004;111:1641-8.
7. Yamamoto T, Iwase A, Araie M, Suzuki Y, Abe H, Shirato S, et al; Tajimi Study Group, Japan Glaucoma Society. The Tajimi study report 2: prevalence of primary angle closure and secondary glaucoma in a Japanese population. Ophthalmology. 2005;112:1661-9.

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