The European Commission (EC) has granted a label extension in the European Union (EU) for Eylea 8mg (aflibercept 8mg, 114.3mg/ml solution for injection) with extended treatment intervals of up to six months for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).
The drug is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for the two diseases.
The higher dose of aflibercept was approved in Australia and added to the Pharmaceutical Benefits Scheme (PBS) from 1 October 2024.
Currently in Australia, the recommended dosing schedule involves three initial monthly injections for both nAMD and DMO, followed by extended dosing intervals of eight to 16 weeks based on visual and or anatomic outcomes.
Following the EC decision, Ms Christine Roth, Bayer’s executive vice president, Global Product Strategy and Commercialisation, said: “Extended treatment intervals with Eylea 8mg can significantly decrease the frequency of injections and clinic visits for patients without compromising efficacy.”
“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 8mg has the potential to establish a new standard of care for retinal diseases.”
The EC decision is 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 randomised to Eylea 8mg 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 six months at the end of three years.
The Bayer media release said the safety profile of Eylea 8mg continued to be favourable in the third year in both studies and was consistent with the well-established safety profile of Eylea 2mg.
The long-term safety data did not show any new signals in both trials, including for patients switching from Eylea 2mg to Eylea 8mg at week 96. The rates for ocular treatment emergent adverse events were similar across all treatment groups.
More reading
Bayer’s Eylea 8mg injection added to PBS
Bayer’s aflibercept 8 mg recommended for approval in EU
IZERVAY Phase 3 clinical study achieves positive 24-month results
