Bayer Eylea 8 mg approved in EU for treatment of two major retinal diseases
Berlin: Bayer has announced that the European Commission has granted marketing authorization in the European Union (EU) for new Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection) for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular edema (DME).
Eylea 8 mg is approved for administration at extended treatment intervals of up to every 4 months, following 3 initial monthly doses. In patients with stable visual outcomes, treatment intervals of up to 5 months may be considered.
According to the Company, Eylea 8 mg is the only treatment in the EU that is approved for extended treatment intervals of up to 5 months in nAMD and DME.
“Eylea 8 mg is an important advancement in retinal care as it provides greater and longer lasting control of the disease. Doctors may extend their patients interval to 4 months, right after 3 initial monthly doses, based on their judgement,” said Jean-François Korobelnik, Professor of Ophthalmology and Head of the Department of Ophthalmology at University Hospital of Bordeaux in France and a trial investigator. “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 DME. 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. Bayer has submitted regulatory applications for aflibercept 8 mg in additional markets. 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.
