EU Approves Eylea™ 8 mg for Extended 6-Month Dosing in nAMD and DME
The European Commission (EC) has approved a label extension for Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection), allowing extended treatment intervals of up to six months for patients with neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). This approval positions Eylea 8 mg as the first and only anti-vascular endothelial growth factor (VEGF) therapy in the EU to offer such prolonged intervals for both retinal diseases.
A New Standard of Care for Retinal Diseases
The extended dosing schedule is seen as a significant step forward in managing these chronic eye diseases. Eylea 8 mg enables longer intervals between injections and clinic visits—up to six months—offering convenience for patients while maintaining strong efficacy and safety profiles.
“Extended treatment intervals with Eylea 8 mg can significantly decrease the frequency of injections and clinic visits for patients without compromising efficacy,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization at Bayer. “This translates to decreased burden of disease for patients and may enhance adherence to treatment. For ophthalmologists, it allows for greater capacity to treat additional patients. Given its distinctive product profile, Eylea 8 mg has the potential to establish a new standard of care for retinal diseases.”
Backed by Long-Term Clinical Data
The EC’s approval is based on data from the third-year, open-label extension phases of the pivotal PULSAR and PHOTON clinical trials. PULSAR evaluated Eylea 8 mg in patients with nAMD, while PHOTON focused on those with DME. Both trials provided evidence supporting the efficacy and safety of extending treatment intervals over three years.
During the open-label extension period (weeks 96 to 156):
- 24% of nAMD patients and
- 28% of DME patients
were successfully maintained on a six-month dosing schedule while preserving both visual and anatomical improvements.
These findings suggest that many patients can be transitioned to significantly less frequent injections without losing therapeutic benefit.
Consistent Safety Profile and Patient Outcomes
The safety profile of Eylea 8 mg in the third year of treatment remained consistent with that of Eylea 2 mg, a widely used therapy with a strong record of clinical success. Importantly, no new safety signals were observed, including among patients who switched from the 2 mg to 8 mg dose at week 96.
The rates of ocular treatment-emergent adverse events were similar across all treatment groups, reinforcing the long-term safety and tolerability of the higher-dose formulation.
Global Reach and Growing Approvals
Eylea 8 mg has now been approved in over 60 countries for the treatment of both nAMD and DME, further cementing its role as a global standard in anti-VEGF therapy. Regulatory filings and reviews in additional markets are underway, signaling continued global momentum for this innovative treatment.
Eylea has already established itself as a market leader in retinal disease treatment, with:
- Over 89 million applications administered, and
- More than 13 million patient-years of clinical experience worldwide.
Joint Development and Commercialization
Eylea 8 mg (also known as Eylea HD in the United States) is the result of a collaborative effort between Bayer and Regeneron. Under their partnership:
- Regeneron retains exclusive rights to Eylea 2 mg and Eylea HD in the U.S.
- Bayer holds exclusive marketing rights outside the U.S.
- Profits from international sales of both 2 mg and 8 mg doses are shared equally between the companies.
Understanding nAMD and DME
Neovascular (Wet) Age-Related Macular Degeneration
nAMD is a rapidly progressing retinal disease that can cause significant vision loss within months if untreated. It is caused by the abnormal growth of blood vessels beneath the macula—leading to fluid leakage, scarring, and damage to central vision.
- 170 million people worldwide currently live with age-related macular degeneration (AMD).
- This number is projected to increase to 288 million by 2040.
- Roughly 10% of AMD cases evolve into the more serious neovascular form (nAMD), which is responsible for most AMD-related vision loss.
Diabetic Macular Edema
DME is a common complication of diabetic retinopathy (DR), where damaged blood vessels leak fluid into the macula, leading to swelling, distortion, and vision loss.
- 146 million people globally are affected by diabetic retinopathy.
- Of those, approximately 27 million develop diabetic macular edema.
- Left untreated, DME can result in irreversible vision loss or blindness.
Given the growing global prevalence of both diabetes and AMD, effective and sustainable treatment strategies are urgently needed—making the six-month dosing option provided by Eylea 8 mg a potentially transformative solution.
Looking Ahead
With its extended dosing schedule and solid safety and efficacy profile, Eylea 8 mg is positioned to ease the burden of care for patients and clinics alike. Its approval in the EU marks another important step in expanding access to long-acting, reliable retinal disease treatment—helping more people maintain vision and quality of life with fewer disruptions.
As Bayer and Regeneron continue their global rollout and regulatory efforts, Eylea 8 mg is poised to set a new benchmark for managing chronic retinal conditions with reduced treatment burden.
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.
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