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.”
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