Eylea™ 8 mg Secures Approval in Japan for Its Third Retinal Disease Indication
The Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorization in Japan for Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of visual impairment caused by macular edema following retinal vein occlusion (RVO). This approval expands the availability of advanced ophthalmic therapies in the country and marks the third approved indication for Eylea 8 mg in Japan, following its prior use in other retinal diseases. The regulatory decision is supported by positive findings from the pivotal Phase III QUASAR clinical trial, which demonstrated the therapy’s efficacy, safety, and potential to reduce treatment burden for patients.
Retinal vein occlusion is a significant ophthalmologic condition and represents the second most common cause of vision loss associated with retinal vascular disorders. It occurs when a blockage forms in the veins responsible for draining blood from the retina, leading to increased pressure, fluid leakage, and ultimately swelling in the macula—the central part of the retina responsible for sharp vision. If not promptly diagnosed and treated, RVO can result in complications such as macular edema and retinal ischemia, both of which contribute to sudden and potentially irreversible vision loss. The disease includes several subtypes, such as branch retinal vein occlusion (BRVO), central retinal vein occlusion (CRVO), and hemiretinal vein occlusion, all of which are covered under this new approval.
A key biological driver of macular edema in RVO is the overexpression of vascular endothelial growth factor (VEGF), a protein that promotes abnormal blood vessel permeability and leakage. Anti-VEGF therapies have therefore become the standard of care in managing retinal vascular diseases. However, one of the major challenges associated with existing treatments has been the need for frequent intravitreal injections, which can place a considerable burden on patients, caregivers, and healthcare systems. This is particularly relevant in chronic conditions like RVO, where long-term management is often required.
The newly approved high-dose formulation of aflibercept offers a potential solution to this challenge. According to Professor Motohiro Kamei of the Department of Ophthalmology at Aichi Medical University, and one of the investigators in the QUASAR study, the results highlight a meaningful advancement in patient care. He noted that while VEGF levels are significantly elevated in patients with macular edema following RVO—necessitating sustained treatment—the QUASAR trial demonstrated that Eylea 8 mg delivers comparable efficacy and safety to the standard 2 mg dose, while reducing the frequency of injections. This reduction in treatment frequency could translate into improved patient adherence and quality of life, as well as decreased strain on outpatient services.
Echoing this perspective, Christine Roth, Executive Vice President of Global Product Strategy and Commercialization at Bayer, emphasized the broader impact of the approval. She highlighted that retinal vein occlusion is among the leading retinal diseases in Japan, second only to age-related macular degeneration. With the introduction of Eylea 8 mg, patients now have access to a more durable therapeutic option that maintains the high standards of efficacy and safety established by earlier formulations while offering longer dosing intervals.
The QUASAR Phase III study provided robust clinical evidence supporting the approval. The trial demonstrated that Eylea 8 mg achieved non-inferior functional outcomes—measured by visual acuity improvements—and comparable anatomical outcomes relative to the standard Eylea 2 mg at 36 weeks. Importantly, after three initial monthly loading doses, patients receiving the 8 mg formulation required significantly fewer injections over time. By week 64, patients treated with Eylea 8 mg received an average of 8.5 injections compared to 11.7 injections in the 2 mg group, representing a meaningful reduction in treatment burden.
Additionally, the study highlighted the extended durability of the higher-dose formulation. More than 60% of patients treated with Eylea 8 mg were able to maintain dosing intervals of four months or longer, while approximately 40% achieved intervals of up to five months. These findings underscore the potential of Eylea 8 mg to transform treatment paradigms by reducing the frequency of clinic visits and injections without compromising disease control. Fluid reduction in the retina—an important marker of therapeutic effectiveness—was also found to be comparable between the extended dosing intervals of Eylea 8 mg and the more frequent dosing schedule of Eylea 2 mg.
From a safety perspective, Eylea 8 mg was well tolerated, with a safety profile consistent with previous clinical experience and earlier trials of aflibercept. No new safety signals were identified, reinforcing confidence in its use across a broad patient population.
Beyond Japan, Eylea 8 mg continues to gain regulatory traction globally. The therapy has recently been approved in the European Union for the treatment of macular edema following RVO and is already authorized in more than 60 markets for conditions such as neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME). In these indications, the drug has established itself as a cornerstone therapy, particularly due to its ability to maintain efficacy while enabling extended dosing intervals.
Notably, Eylea 8 mg is currently the first and only anti-VEGF therapy approved in regions such as the EU and the United Kingdom for treatment intervals of up to six months in both nAMD and DME. This distinction further highlights its innovative profile and positions it as a leading option in the evolving landscape of retinal disease management.
The development of Eylea 8 mg is the result of a long-standing collaboration between Bayer and Regeneron Pharmaceuticals. Under this partnership, Regeneron Pharmaceuticals retains exclusive rights to market both the 2 mg and high-dose (branded as Eylea HD in the United States) formulations domestically, while Bayer holds exclusive commercialization rights outside the United States. The companies share profits equally from global sales of both Eylea 2 mg and Eylea 8 mg, reflecting a strategic alliance that has successfully brought innovative ophthalmology treatments to patients worldwide.
In Japan, the newly approved regimen for Eylea 8 mg in RVO allows for injection intervals of four weeks or longer, depending on individual patient response and physician assessment. This flexibility in dosing, combined with the drug’s demonstrated durability, provides clinicians with an important tool to tailor treatment strategies according to patient needs.
Overall, the approval of Eylea 8 mg for macular edema following retinal vein occlusion represents a significant advancement in ophthalmic care. By combining proven efficacy and safety with the potential for extended dosing intervals, the therapy addresses a critical unmet need in reducing treatment burden while maintaining optimal visual outcomes. As healthcare systems continue to prioritize patient-centered care and efficiency, innovations such as Eylea 8 mg are expected to play an increasingly important role in shaping the future of retinal disease management.
About RVO
Retinal vein occlusion (RVO) is a chronic condition that currently affects 28 million adults globally and can lead to sudden, rapid vision loss. There are two main types of RVO – central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO). CRVO occurs when there is a blockage in the main vein of the retina at the optic nerve. BRVO occurs when the smaller, branch retinal veins are obstructed, and is up to six times more common than CRVO. Hemiretinal vein occlusion (HRVO), a less common subtype, refers to the occlusion of a vein that supplies one half of the retina.
RVO can lead to a reduced oxygen supply to the retina, increasing the production of vascular endothelial growth factor (VEGF) and placental growth factor (PlGF). The blocked vein can cause fluid and blood to leak into the retina resulting in swelling and bleeding within the macula, the part of the eye responsible for sharp central vision and seeing fine detail. This swelling is called macular edema, and VEGF plays a major role in driving this pathology.
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 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com.
Source Link:https://www.bayer.com/
