Aflibercept intraocular injection kit 40 mg/mL Bayer Listed in NHI Drug Price List

December 5, 2025, Osaka, Japan – Santen Pharmaceutical Co., Ltd. (head office: Osaka, Japan; hereinafter Santen) and Bayer Life Science Ltd. (head office: Osaka, Japan; hereinafter Bayer Life Science), a subsidiary of Bayer Holding Ltd. (head office: Chiyoda-ku, Tokyo, Japan) announced that the ophthalmic Vascular Endothelial Growth Factor (VEGF) inhibitor, Aflibercept intraocular injection kit 40 mg/mL Bayer*, for which Bayer Life Science has received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare (MHLW) has been listed in the National Health Insurance (NHI) Drug Price List.

This bioidentical product has the same active ingredient, excipients, and manufacturing process as the ophthalmic vascular endothelial growth factor (VEGF) inhibitor Eylea^® intraocular Injection 40 mg/mL, for which Bayer Yakuhin Ltd. (Head office: Osaka, Japan; hereinafter Bayer Yakuhin) obtained manufacturing and marketing authorization in 2012, and Santen has been distributing as "Eylea^® intraocular Injection Kit 40 mg/mL" in Japan. This product has four indications: Age-related macular degeneration with subfoveal choroidal neovascularization, Macular edema secondary to retinal vein occlusion, Choroidal neovascularization in pathologic myopia, and Diabetic macular edema.

Santen is responsible for promotional activities to medical institutions, as well as distribution and sales** of the product. Through the collaboration between Bayer Life Science and Santen, the two companies aim to meet the diverse needs of patients in the field of retinal diseases and contribute to treatments that enhance quality of life.

* Launch date undecided
** Using the distribution network of Santen

About Eylea^®
Eylea^® is an ophthalmic VEGF (Vascular Endothelial Growth Factor) inhibitor with the aim of creating a drug that has high binding affinity to VEGF. Eylea^® 8 mg (aflibercept 8 mg; in the United States and Canada: Eylea^® HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea^® 2 mg (aflibercept 2 mg) and Eylea^® HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea^® 2 mg and Eylea^® 8 mg following any regulatory approvals.

In Japan, Eylea^® 2 mg has six indications, the most for any Ophthalmic VEGF inhibitor, covering a broad spectrum of exudative retinal diseases in anti-VEGF treatment.^1） Eylea^® 8 mg (Eylea^® 8 mg Solution for Intravitreal Injection 114.3 mg/mL, Eylea^® 8 mg Intravitreal Injection Kit 114.3 mg/mL) is indicated for the treatment of age-related macular degeneration with subfoveal choroidal neovascularization and diabetic macular edema. In Japan, Eylea^® 8 mg and Eylea^® 2 mg are distributed by Santen, while the marketing authorization for the drugs are held by Bayer Yakuhin. Both companies will jointly provide drug information services for them.

• 1）The common indications of Eylea^® 2 mg (“Eylea^® Intravitreal Injection 40 mg/mL” and “Eylea^® Intravitreal Injection Kit 40 mg/mL”) are age-related macular degeneration with subfoveal choroidal neovascularization, macular edema secondary to retinal vein occlusion, choroidal neovascularization in pathological myopia, diabetic macular edema, and neovascular glaucoma. Additionally, Eylea^® Intravitreal Injection 40 mg/mL is indicated for retinopathy of prematurity.

About Santen
Santen is a global pharmaceutical company committed to advancing eye health and improving lives through better vision. Founded in 1890 in Osaka, Japan, Santen makes use of more than 135 years of experience in research and development, manufacturing, and marketing of pharmaceuticals and medical devices to help people around the globe maintain and improve their eye health. Santen focuses exclusively on eye health and its portfolio includes glaucoma, dry eye, infection, allergy, age-related macular degeneration, and myopia. Santen’s products and services are available in more than 60 countries and regions. Guided by its Core Principle “Tenki ni sanyo suru” – Exploring the secrets and mechanisms of nature in order to contribute to people’s health – Santen combines its expertise with deep patient focus to contribute to the realization of “Happiness with Vision.”
For more information, please visit https://www.santen.com/en.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.

About Bayer Life Science
Bayer Life Science Ltd. is a wholly-owned subsidiary of Bayer Holding Ltd., specializing in the manufacturing and marketing of pharmaceutical products. The company offers life science solutions for patients and healthcare professionals, addressing the evolving demands of society, healthcare needs, and technological advancements. For further information, please visit www.bayer.jp/ja/bayerlifescience.

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

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Bayer Holding Ltd.
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