Santen Launches SETANEO^® Ophthalmic Solution 0.002% in Japan for the Treatment of Glaucoma and Ocular Hypertension

October 23, 2025 – Osaka, Japan – Santen Pharmaceutical Co., Ltd. (hereafter Santen) announced today that it launched SETANEO^® Ophthalmic Solution 0.002% (generic name: sepetaprost; hereafter the product) in Japan, for the treatment of glaucoma and ocular hypertension.

The product contains 0.002% sepetaprost, a bicyclic prostaglandin derivative, which binds to and stimulates FP and EP3 receptors, promoting aqueous humor outflow and thereby lowering intraocular pressure (IOP). Based on the results of a Phase III clinical trial conducted in Japan, Santen submitted a manufacturing and marketing authorization application in September 2024 and obtained approval in August 2025 for the treatment of glaucoma and ocular hypertension.

In the treatment of glaucoma, when monotherapy with an IOP-lowering ophthalmic solution is insufficient, combination therapy (including fixed-dose combinations) is considered.¹ However, multiple medications may increase the risk of adverse effects and decrease patient adherence* and quality of life (QOL) due to increased dosing frequency. Accordingly, the emergence of a powerful IOP-lowering agent with a novel mechanism of action is highly anticipated. Santen will provide a new treatment option for patients with glaucoma through the launch of this product, which stimulates both FP and EP3 receptors with a single active ingredient.

Ippei Kurihara, Director of the Board, Head of Japan Business, Business Development at Santen, commented: “We are very pleased to launch SETANEO^® Ophthalmic Solution 0.002% in Japan. We believe this product has the potential to become a new first-line treatment for glaucoma, expanding the range of therapeutic options and enabling more personalized care for each patient.”

As a specialized company dedicated to ophthalmology, Santen seeks to contribute to the improved QOL of glaucoma patients in Japan by providing new treatment options to the medical community.

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About Glaucoma
Glaucoma is a disease in which elevated intraocular pressure and other factors damage the optic nerve, leading to progressive visual field loss and potentially resulting in blindness if left untreated. It remains the leading cause of visual impairment (including vision loss and blindness) due to eye disease in Japan.² The estimated number of patients with glaucoma worldwide was 64.3 million in 2013 and is projected to increase to 111.8 million by 2040.³ Among Japanese individuals aged 40 years and older, the prevalence of glaucoma was 5.0% (3.9% primary open-angle glaucoma, 0.6% primary angle-closure glaucoma, and 0.5% secondary glaucoma), while ocular hypertension was observed in 0.8%.^4-5 The prevalence of glaucoma is known to increase with age⁴, and with Japan’s aging population, the number of patients is expected to rise further. As such, early detection and early treatment are considered increasingly important.

Clinical Trials of SETANEO^® Ophthalmic Solution 0.002% in Japan
In a Phase III confirmatory trial involving patients with primary open-angle glaucoma or ocular hypertension, the non-inferiority of once-daily instillation of this product was demonstrated in comparison with once-daily instillation of 0.005% latanoprost ophthalmic solution, one of the first-line therapies for glaucoma. In a long-term study involving patients with open-angle glaucoma or ocular hypertension, this product showed sustained intraocular pressure control with once-daily instillation over a one-year period (52 weeks). Regarding safety, iris pigmentation was observed as a serious adverse reaction in 1 of 314 patients (0.3%). The most common adverse reactions (occurring in ≥5% of patients) included conjunctival hyperemia, eyelash abnormalities, and eyelid hypertrichosis.

• The patient takes an active role in deciding their treatment plan and follows through with the agreed-upon care.

References

1. Glaucoma Treatment Guidelines (5^th edition). Jpn J Ophthalmol. 126 (2): 85-177, 2022.
2. Matoba R, et al. Jpn J Ophthalmol. 67(3):346–352, 2023.
3. Tham YC, et al. Ophthalmology. 121:2081-2090, 2014.
4. Iwase A, et al; Ophthalmology. 111:1641-1648, 2004.
5. Yamamoto T, et al; Ophthalmology. 112:1661-1669, 2005.

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