Bayer’s higher dose aflibercept 8 mg with extended treatment intervals is set for approval in the European Union (EU) for neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME).
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the treatment based on positive results from the PULSAR clinical trial in nAMD and PHOTON trial in DME.
If approved by the European Commission, aflibercept 8 mg will be the only drug providing extended treatment intervals of up to five months for patients with nAMD and DME, the company stated.
This includes injections with aflibercept 8 mg at extended treatment intervals of up to every four months, after three initial monthly doses. In patients with stable visual outcomes, treatment intervals of up to five months may be considered.
Currently, in Australia, lower dose aflibercept (brand name, Eylea) has been the leading anti-VEGF therapy since it was first approved for nAMD 2012. It is initiated with one injection per month for five consecutive months, followed by one injection every two months. After the first 12 months, the treatment interval may be extended based on visual and anatomic outcomes.
For aflibercept 8 mg, the clinical studies consisted of 12- or 16-week dosing regimens compared to Eylea (aflibercept 2 mg) with a fixed eight-week treatment interval at week 48. Both studies met their primary endpoint of “non-inferior best corrected visual acuity” changes.
“The clinical trials with aflibercept 8 mg have demonstrated sustained vision gains with extended treatment intervals, rapid and resilient fluid control, and a comparable safety profile to Eylea 2 mg,” said Dr Paolo Lanzetta, chairman of the Department of Ophthalmology at the University of Udine, Italy, and member of the steering committee of the clinical trials.
“This concept of sustained disease control has been eagerly anticipated, because greater and longer lasting control of disease activity is needed to alleviate disease burden for patients and capacity constraints at eye clinics and ophthalmologists’ offices.
“This can contribute to improved patient adherence and persistence, and support physicians to free up resources to help more patients.”
Dr Christian Rommel, member of the executive committee of Bayer’s pharmaceuticals division and head of research and development, said Eylea had already transformed the standard of care for millions of people in the EU living with nAMD and DME.
“This positive CHMP opinion underscores the potential of aflibercept 8 mg to set a new benchmark for the treatment of these progressive blinding diseases,” he said.
The final decision from the European Commission is expected in the coming months, according to a statement by the company. Bayer has applied for the brand name of aflibercept 8 mg to be ‘Eylea 114.3 mg/ml solution for injection’ (Eylea 8mg).
Aflibercept 8 mg was approved for use by the FDA on August 18, 2023, with Bayer submitting regulatory applications for aflibercept 8 mg in additional key markets.
Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg in the US, with Bayer licensing the exclusive marketing rights outside the country.
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