European Commission Grants Approval for Eylea™ 8 mg with Extended 6-Month Dosing Interval in Patients with nAMD and DME
The European Commission (EC) has officially approved a label extension for Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/mL solution for injection) across the European Union (EU), allowing for extended treatment intervals of up to six months for individuals diagnosed with neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME). This decision marks a major advancement in the management of two of the most common and sight-threatening retinal conditions and positions Eylea 8 mg as the first and only anti-VEGF therapy in the EU to offer such prolonged dosing intervals for both nAMD and DME.
This extended dosing option is expected to have a profound impact on clinical practice and patient quality of life, particularly for those burdened by the frequency of intravitreal injections currently associated with anti-VEGF treatments.
A New Standard of Care for Retinal Diseases
Commenting on the significance of the EC’s decision, Christine Roth, Executive Vice President of Global Product Strategy and Commercialization and a member of the Pharmaceuticals Leadership Team at Bayer, emphasized the potential benefits for both patients and clinicians.
“Extended treatment intervals with Eylea 8 mg can significantly decrease the frequency of injections and clinic visits for patients without compromising efficacy,” Roth stated. “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.”
The label extension opens a promising pathway for simplifying treatment regimens in chronic retinal diseases that typically require intensive and frequent therapeutic intervention. By reducing the injection burden, Eylea 8 mg aims to foster higher treatment adherence, lessen logistical hurdles, and ultimately improve long-term vision outcomes.
Robust Clinical Evidence from PULSAR and PHOTON Trials
The EC’s decision was primarily based on long-term data derived from the pivotal PULSAR and PHOTON Phase 3 trials, including data from their third-year open-label extension phases (weeks 96–156). These studies were designed to evaluate the safety, durability, and efficacy of Eylea 8 mg in maintaining vision and anatomical outcomes in patients with nAMD and DME, respectively.
Participants in both studies who were originally randomized to receive Eylea 8 mg from baseline continued into the extension period without interruption. By the end of the third year, results showed that 24% of patients with nAMD in the PULSAR trial and 28% of patients with DME in the PHOTON trial were able to maintain their visual and anatomical improvements while being treated at 6-month intervals.
These figures are particularly notable as they reflect real-world feasibility of extended dosing intervals without sacrificing therapeutic benefit—an achievement that aligns with ongoing efforts to make treatment regimens more patient-centric.
Favorable Safety Profile Maintained Over Three Years
The long-term safety profile of Eylea 8 mg remained consistent and favorable throughout the three-year observation period. Importantly, no new safety concerns or adverse signals were identified in patients who received the 8 mg dose from the beginning of the trial, nor among those who switched from Eylea 2 mg to Eylea 8 mg at week 96.
Rates of ocular treatment-emergent adverse events (TEAEs) were comparable across all treatment groups in both trials, affirming that the higher-dose formulation does not introduce additional risk. This consistency supports the clinical robustness and safety of Eylea 8 mg over an extended treatment period.
The favorable safety profile also underscores the suitability of Eylea 8 mg for use in routine clinical practice, particularly in a population that is often older and more vulnerable to complications.
Global Impact and Regulatory Expansion
Eylea 8 mg has already received approval for the treatment of nAMD and DME in over 60 markets globally, and regulatory submissions for label expansions and market authorizations are currently underway in multiple additional jurisdictions. The global uptake of Eylea 8 mg reflects a growing consensus among regulatory bodies and clinical experts regarding the value of extended-interval anti-VEGF therapy in retinal disease management.
In the United States, Eylea 8 mg is marketed as Eylea HD, and has received separate regulatory approvals distinct from its European branding. The product’s dual-branding approach allows it to meet specific regional regulatory and commercial requirements while maintaining consistency in clinical formulation and efficacy.
The Evolution of Eylea: From Breakthrough to Backbone
Since its initial approval, Eylea (aflibercept) has solidified its position as a market-leading therapy for retinal diseases driven by vascular endothelial growth factor (VEGF) dysregulation. With more than 89 million injections administered and over 13 million patient-years of real-world experience, Eylea has been foundational in transforming the treatment landscape for retinal disorders.
The introduction of the 8 mg formulation and its newly approved 6-month dosing interval further builds on this legacy, offering an advanced option for patients seeking to reduce the physical and emotional toll of frequent treatments.
The extended-interval label expansion is expected to be particularly impactful for patients in rural or underserved areas, where access to ophthalmology services may be limited, and for those who struggle with transportation or caregiving responsibilities.
Strategic Partnership: Bayer and Regeneron
The development and commercialization of Eylea 8 mg is a product of the ongoing strategic collaboration between Bayer and Regeneron Pharmaceuticals. Under the terms of their global partnership:
- Regeneron retains exclusive commercialization rights for Eylea (both the 2 mg and 8 mg formulations, including Eylea HD) in the United States.
- Bayer holds exclusive marketing rights outside the U.S., where both companies equally share profits generated from international sales.
This collaboration has enabled rapid development and broad market access for Eylea 8 mg and has played a key role in supporting its clinical validation and global reach.
Shaping the Future of Retinal Disease Management
The European Commission’s approval of extended 6-month dosing intervals for Eylea 8 mg is a significant step forward in the evolution of anti-VEGF therapy. It addresses a long-standing clinical need for durable, effective, and safe treatments that can lessen the burden on patients and healthcare systems alike.
As further data from ongoing real-world studies and registries become available, Eylea 8 mg may help redefine expectations for how chronic retinal diseases are managed across Europe and beyond.
By offering a treatment option that maintains efficacy while reducing the treatment burden, Bayer and Regeneron are not only advancing therapeutic innovation but also aligning their strategy with patient-centric care models that emphasize sustainability, accessibility, and quality of life.
