Aflibercept 8 mg recommended for EU approval for third retinal indication

Bayer

12 December 2025 - Positive opinion of the CHMP is based on the outcomes from the clinical Phase 3 trial QUASAR in patients with macular oedema following retinal vein occlusion including branch, central and hemi-retinal vein occlusion.

The CHMP of the EMA has recommended aflibercept 8 mg (114.3 mg/mL solution for injection) for marketing authorisation in the European Union for the treatment of patients with visual impairment due to macular oedema following retinal vein occlusion including branch, central and hemi-retinal vein occlusion. 

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Michael Wonder

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Michael Wonder