Eylea 8 mg (aflibercept 8 mg) for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO) has been granted marketing authorisation in the European Union (EU) by the European Commission.
Eylea 8 mg is approved for administration at extended treatment intervals of up to every four months, following three initial monthly doses. In patients with stable visual outcomes, treatment intervals of up to five months may be considered.
Eylea 8 mg is the only treatment in the EU that is approved for extended treatment intervals of up to five months in nAMD and DMO.
Jean-François Korobelnik, Professor of Ophthalmology and Head of the Department of Ophthalmology at University Hospital of Bordeaux in France and a trial investigator said the ability to meet these extended treatment intervals makes Eylea 8 mg “an important advancement in retinal care”.
“This then does not only mean less eye injections and doctor visits for patients but could also help to mitigate capacity constraints faced in clinical practices in Europe.”
“The approval of Eylea 8 mg in the European Union marks a significant milestone in addressing the high unmet need to reduce the patients’ burden of retinal disease,” said Dr Michael Devoy, Chief Medical Officer of Bayer’s Pharmaceuticals Division. “Building on the standard of care therapy Eylea 2 mg, patients have now the opportunity to benefit from Eylea 8 mg with less frequent injections with comparable efficacy and safety to Eylea 2 mg.”
The EU approval is based on positive results from the PULSAR clinical trial in nAMD and the PHOTON trial in DMO. Both studies met their primary endpoint of non-inferior best corrected visual acuity (BCVA) changes with aflibercept 8 mg with 12- or 16-week dosing regimens compared to aflibercept 2 mg (Eylea 40 mg/ml) with a fixed 8-week treatment interval at week 48. In these studies, the safety profile of aflibercept 8 mg was consistent with the well-established safety profile of Eylea (aflibercept 2 mg).
Aflibercept 8 mg was approved under the brand name Eylea HD by the United States Food and Drug Administration (FDA) in August 2023. It was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) on 18 January 2024 and an application for regulatory approval has been accepted in China.
Aflibercept 8 mg is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea (aflibercept 2 mg) and Eylea HD in the United States. Bayer has licensed the exclusive marketing rights outside the United States, where the companies share equally the profits from sales of Eylea and Eylea 8 mg.
Reference
New Eylea 8 mg approved in EU. www.bayer.com/media/en-us/new-eylea-8-mg-approved-in-eu/#
