Santen Obtains Manufacturing and Marketing Approval in Japan for SETANEO^® 0.002% Ophthalmic Solution, a Bicyclic Prostaglandin Derivative that Acts on FP and EP3 Receptors, for Treatment of Glaucoma and Ocular Hypertension

August 25, 2025 - Osaka, Japan - Santen Pharmaceutical Co., Ltd. (hereinafter Santen) announced today that it has obtained manufacturing and marketing approval in Japan for SETANEO^® ophthalmic solution 0.002% (generic name: sepetaprost; development code: STN1012600; hereinafter the product) for the treatment of glaucoma and ocular hypertension. The approval was granted on August 25, 2025.

This product contains 0.002% sepetaprost, a compound originally developed by Ono Pharmaceutical Co., Ltd. Sepetaprost is a prodrug that is rapidly hydrolyzed, primarily in the cornea, following administration and is thought to promote aqueous humor outflow by binding to and stimulating the FP receptor and EP3 receptor, thereby exerting an intraocular pressure-lowering effect.

The efficacy of this product was confirmed through a Phase III clinical trial conducted in Japan, where it was shown to be non-inferior to 0.005% latanoprost ophthalmic solution (administered once daily), one of the first-line treatments for glaucoma, in terms of intraocular pressure-lowering efficacy based on once-daily administration. In addition, in a long-term clinical trial conducted in Japan, this product demonstrated intraocular pressure control with once-daily administration over a one-year period. From a safety perspective, the following serious adverse effect has been reported: iris pigmentation (0.3%). The main adverse effects, with an incidence rate of 5% or higher, include conjunctival hyperemia, abnormal eyelash growth, and eyelid hypertrichosis.

Glaucoma is a disease in which the optic nerve is damaged by increased intraocular pressure or other factors, causing progressive visual field loss. Without appropriate treatment, the condition can lead to blindness. It remains the leading 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, early diagnosis and treatment intervention is critically important.

The Japan Glaucoma Society’s Glaucoma Treatment Guidelines (5th edition) recommend initiating pharmacological treatment of glaucoma with a monotherapy (single drug) using an intraocular pressure-lowering eye drop²; if efficacy is not confirmed, then the medication should be changed to another agent. If efficacy remains insufficient, then combination therapy (including fixed-dose combination eye drops) is used. When selecting a medication, it is necessary to take into consideration the existence of treatment-resistant patients, contraindications for administration, and potential adverse effects. When combination therapy is used, it is also necessary to consider the potential for increased adverse effects associated with increased frequency of eye drop administration, as well as the risk of decreased patient adherence^* and quality of life (QOL). For these reasons, there is a need for new intraocular pressure-lowering drugs that demonstrate a powerful intraocular pressure-lowering effect based on a new mechanism of action.

Santen’s Chief Medical Officer Peter Sallstig commented: “In glaucoma treatment, prostanoid receptor-related agents are most commonly used as first-line drugs due to their superior intraocular pressure-lowering effect, frequency of administration, and good tolerability in terms of adverse effects.² However, existing prostanoid receptor-related agents are not always effective. In addition, intraocular pressure is not constant and fluctuates throughout the day, so it is important to control intraocular pressure during the day and at night to slow the progression of glaucoma. We are very pleased that the approval of SETANEO^® ophthalmic solution 0.002% will provide more glaucoma patients with a new option for eye drops that lower intraocular pressure through two new mechanisms of action.”

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

About 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 2040.³ 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.^{4, 5} 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.

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

References

1. Matoba R, et al. Jpn J Ophthalmol. 2023;67(3):346–352.
2. Glaucoma Treatment Guidelines (5^th edition). Jpn J Ophthalmol. 2022;126: (2): 85-177
3. Tham YC, et al. Ophthalmology. 2014;121:2081-90.
4. Iwase A, et al; Ophthalmology. 2004;111:1641-8.
5. Yamamoto T, et al; 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