EU expands Eylea 8 mg label to include longer intervals for nAMD and DME
The European Commission (EC) has approved Eylea™ 8 mg (aflibercept 8 mg, 114.3 mg/mL solution for injection) for extended treatment intervals of up to six months in both neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME).
This label extension is based on data from the year 3 open-label extension phases of the pivotal Phase III PULSAR and PHOTON trials.
A longer leash for anti-VEGF care
On June 27, 2025, the European Commission granted a label extension for Eylea 8 mg, authorizing 6-month treatment intervals for patients with nAMD or DME after the initial monthly loading doses, per trial protocols.
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The change is based on long-term clinical outcomes from the PULSAR (nAMD) and PHOTON (DME) studies, in which patients demonstrated sustained anatomical and functional improvements through week 156.
Eylea 8 mg is now the first anti-VEGF therapy approved in the European Union with this extended interval indication for both conditions.
The data behind the decision
Patients who received Eylea 8 mg from baseline maintained their vision and anatomic outcomes, with many able to stretch intervals between injections to half a year by the end of year three.
In the extension phase (weeks 96 to 156), 24% of nAMD patients and 28% of DME patients achieved a final assigned interval of 6 months. Visual acuity and anatomic improvements were maintained across groups, and safety data remained consistent with the Eylea 2 mg profile. No new safety signals emerged, even among patients who switched from Eylea 2 mg to 8 mg.
These data support the potential for sustained disease control with fewer injections over time in selected patients.
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Easing the injection grind
Anti-VEGF therapy typically requires frequent intravitreal injections, which can be burdensome for both patients and healthcare systems. The approval of extended dosing intervals for Eylea 8 mg introduces an alternative treatment schedule that may reduce the number of clinic visits while maintaining therapeutic efficacy.
According to Christine Roth, Executive VP of Global Product Strategy at Bayer (Berlin, Germany), “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.”
Market availability and ongoing research
Eylea 8 mg has been approved in over 60 markets for the treatment of nAMD and DME. Additional regulatory submissions are currently under review. Bayer holds exclusive marketing rights outside the United States, sharing global revenues with Regeneron (Tarrytown, NY, USA), which retains U.S. rights.
READ MORE: Bayer’s Eylea 8mg Makes Huge Regulatory Strides Worldwide
The long-term safety and efficacy data from PULSAR and PHOTON contribute to an expanding body of evidence evaluating the role of extended-interval dosing in retinal disease management.
Editor’s note: Read the full press release from Bayer here.