European Commission grants label extension for Eylea 8 mg with extended 6-month treatment interval

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The European Commission (EC) has granted a label extension in the European Union (EU) for aflibercept 8 mg (Eylea) with extended treatment intervals of up to 6 months for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME).

Christine Roth, executive vice president at Bayer commented on the Commission’s decision in a press release from the company.

“Extended treatment intervals with Eylea 8 mg can significantly decrease the frequency of injections and clinic visits for patients without compromising efficacy,” said Roth. “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 company noted that the EC’s decision was based on additional positive results from the third year open-label extension phase of the pivotal clinical trials PULSAR in nAMD and PHOTON in DME. In both extension phases (study weeks 96-156), patients originally randomized to Eylea 8 mg at week 0 maintained their visual and anatomic improvements, with 24% of patients in nAMD and 28% of patients in DME having a last assigned dosing interval of 6 months at the end of 3 years.

The company also noted that the safety profile of Eylea 8 mg continued to be favourable in the third year in both studies and is consistent with Eylea 2 mg. Eylea 8 mg (Eylea HD in the US) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg and Eylea HD in the US. Bayer has licensed the exclusive marketing rights outside the US, where the companies equally share the profits from sales of Eylea 2 mg and Eylea 8 mg.

Reference:

• European Commission approves Eylea 8 mg with extended 6-month treatment interval for nAMD and visual impairment due to DME. Published June 28, 2025. Accessed June 30, 2025. https://www.bayer.com/media/en-us/eylea-8-mg-with-extended-6-month-treatment-interval-approved-in-the-eu/