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CHMP Positive Opinion for 8mg Eylea® (Aflibercept)

Nov 10, 2023

Bayer announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 8mg Eylea® (aflibercept) intravitreal injection for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), with treatment intervals of up to five months.

The US FDA approved 8mg Eylea® in August 2023.

Aflibercept 8 mg was jointly developed by Bayer and Regeneron.  Bayer reported that Regeneron has exclusive rights to Eylea 2mg and 8mg in the US, and Bayer has the exclusive marketing rights outside the US.