Japan Approval Obtained for Ophthalmic VEGF inhibitor Eylea®8mg Solution for Intravitreal Injection 114.3 mg/mL

January 18, 2024, Osaka, Japan – Santen Pharmaceutical Co., Ltd. (head office: Osaka, Japan; hereinafter, Santen) and Bayer Yakuhin, Ltd. (head office: Osaka, Japan; hereafter, Bayer Yakuhin) announced today that, following an application by Bayer Yakuhin, they had obtained regulatory approval from the Ministry of Health, Labour, and Welfare (MHLW) for ophthalmic Vascular Endothelial Growth Factor (VEGF) inhibitor "Eylea®8mg Intravitreal Injection 114.3 mg/mL" (aflibercept [recombinant] intravitreal injection; hereafter, Eylea®8mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).

The approval is based on results from the PULSAR clinical trial in nAMD and the PHOTON clinical trial in DME. Both studies met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes with Eylea®8mg with 12- or 16-week dosing regimens compared to Eylea® (aflibercept 2 mg) with a fixed 8-week treatment interval at week 48, following initial monthly doses. In these studies, the safety profile of Eylea®8mg was consistent with the safety profile of Eylea® (aflibercept 2 mg). This would mean a considerable reduction in disease burden for patients while providing sustained disease control.

Eylea®8mg will be distributed in Japan by Santen, with manufacturing and marketing authorization held by Bayer Yakuhin. Promotional activities for this drug will be conducted jointly by both companies.

Product Summary of Eylea®8mg Intravitreal Injection 114.3 mg/mL
Brand nameEylea®8mg Solution for Intravitreal Injection 114.3 mg/mL
Generic nameAflibercept (recombinant)

Age-related macular degeneration with subfoveal choroidal neovascularization

Diabetic macular edema

Dosage8 mg (0.07 mL) administered by intravitreal (IVT) injection once every 4 weeks, usually 3 times consecutively (initial phase). The number of consecutive doses may be reduced depending on symptoms. In the subsequent maintenance phase, it is usually administered intravitreally once every 16 weeks. The dosing interval may be adjusted according to the patient’s symptoms, but it should be ≥8 weeks.
Date of marketing approvalJanuary 18, 2024
Manufactured and marketed byBayer Yakuhin, Ltd.
Distributed bySanten Pharmaceutical Co., Ltd.

PULSAR and PHOTON are randomized, double-masked, active-controlled pivotal trials. Both trials were conducted in multiple centers globally with similar designs and endpoints. The Phase III PULSAR trial in nAMD and Phase II/III PHOTON trial in DME evaluated the efficacy and safety of aflibercept 8 mg with 12- and 16-week dosing regimens versus Eylea®(aflibercept 2 mg) dosed every 8 weeks, following initial monthly doses, with the primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) changes at week 48. Patients in both clinical trials were randomized at baseline to the three different arms. Across both studies, 1,164 patients were treated with aflibercept 8 mg. All patients in the aflibercept 8 mg arms were continuously evaluated under stringent, clinically relevant, patient focused dose regimen modification (DRM) criteria starting from week 16 throughout the study. In the first year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened down to an every 8-week interval if DRM criteria for disease progression were observed. Intervals could not be extended until the second year of the study. In the second year, patients in the aflibercept 8 mg groups could have their dosing intervals shortened or extended if DRM criteria were met. Patients in all Eylea® (aflibercept 2 mg) groups maintained a fixed 8-week dosing regimen throughout their participation in the trials. The two-year data mark the end of the masked study (week 96) with the option to extend treatment intervals up to 24 weeks and with an optional 1-year open-label extension for patients until week 156.

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 responsible for sharp central vision and seeing fine detail. This fluid can damage and scar the macula, which can cause vision loss. 196 million people worldwide are living with AMD – it is anticipated that this figure will increase to 288 million by 2040. Approximately 10-15% of people with AMD will develop the advanced form nAMD.

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 (DR), which can develop into a more serious condition which is DME. DME is affecting around 21 million people globally.

About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its 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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.

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.

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Santen Pharmaceutical Co., Ltd.
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Bayer Yakuhin, Ltd.
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