Santen and Bayer Yakuhin Launch New Pre-Filled Syringe for EYLEA^® 8 mg, EYLEA^® 8 mg intraocular injection kit 114.3 mg/mL

May 21, 2025 – Osaka, Japan – Santen Pharmaceutical Co., Ltd. (head office: Osaka, Japan, hereinafter Santen) and Bayer Yakuhin, Ltd. (head office: Osaka, Japan; hereinafter Bayer Yakuhin) announced today that they have launched a pre-filled syringe for the ophthalmic Vascular Endothelial Growth Factor (VEGF) inhibitor Eylea^® 8 mg intraocular injection 114.3mg/mL (aflibercept [recombinant] solution for intraocular injection, hereinafter Eylea^® 8 mg), EYLEA^® 8 mg intraocular injection kit 114.3 mg/mL (hereinafter EYLEA^® 8mg pre-filled syringe).

EYLEA^® 8 mg pre-filled syringe is a pre-filled syringe that uses a new dosage-setting mechanism known as OcuClick^®, which not only simplifies preparation but also provides medical professionals with an efficient and simple way to accurately deliver EYLEA^® 8 mg. In addition, there is no longer a need to transfer the drug from vial to syringe. Compared to the existing EYLEA^® 8 mg vial formulation, the pre-filled syringe is expected to reduce the burden on medical professionals while improving the efficiency of administration.

EYLEA^® 8 mg and EYLEA^® 8 mg pre-filled syringe are approved for the treatment of neovascular (wet) age-related macular degeneration (nAMD)^* and diabetic macular edema (DME). In the maintenance phase for these diseases following introduction phase therapy, EYLEA^® 8 mg allows for extended treatment intervals while maintaining comparable efficacy and safety to EYLEA^® 40 mg/mL intraocular injection (hereinafter EYLEA^®). By enabling sustained disease control and reducing the burden on medical professionals and patients, EYLEA^® 8 mg in the pre-filled syringe is expected to become a new standard of care for these diseases.

As is the case with EYLEA^® and EYLEA^® 8 mg, Santen will be responsible for the distribution of EYLEA^® 8 mg pre-filled syringe in Japan, while Bayer Yakuhin retains manufacturing and marketing authorization for the product. Both companies will continue to jointly provide drug information services. Both companies are striving to provide products addressing unmet needs as part of their commitment to further contribute to treatments that enhance the quality of life of patients with retinal diseases.

Product Photograph

^* [Features of prefilled syringe with dosage-setting mechanism (OcuClick®)]
EYLEA® 8 mg pre-filled syringe uses a pre-filled syringe with a new dosage setting mechanism. OcuClick® is expected to offer the following benefits:

• Simplified prep work prior to administration: There is no need to transfer the drug from vial to syringe. There is no dose line marking on the syringe, so there is no need to prime the syringe to the dose line. Follow the instructions and set the dosage to 0.07mL.
• Accurate delivery of the required dose: The syringe mechanism allows intraocular administration only after the preset single dose of 0.07 mL has been selected. Follow the instructions and the appropriate dose will be administered.

About nAMD and DME
Neovascular (wet) age-related macular degeneration (nAMD) is an eye disease that progresses rapidly and, if left untreated, can lead to vision loss in a few months. nAMD is one of the leading causes of irreversible blindness and vision impairment around the world. nAMD may affect people as they age. It occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye deeply involved in controlling central vision to maintain sharp vision. This fluid can damage and scar the macula, thereby causing vision loss. Currently, 170 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. ¹ Approximately 10% of people with AMD will develop the advanced form nAMD.²

Diabetic macular edema (DME) is a common complication in eyes of people living with diabetes. DME occurs when high levels of blood sugar lead to damaged blood vessels in the eye that leak fluid into the macula. This can lead to vision loss and, in some cases, blindness. Globally, 146 million people are currently living with diabetic retinopathy,³ which can develop into a more serious condition which is DME. DME is estimated to affect around 27 million people globally.⁴

References

1. Khachigian LM, et al. J Transl Med 2023;21:133.
2. Morris B, et al. Postgrad Med J 2007;83:301–307.
3. WHO. 2019. World Report on Vision. Available at: https://www.who.int/publications-detail/world-report-on-vision.
4. Cheung N, et al. Eye (Lond) 2020;34:999–1002.

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.

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 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.com.

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