Eylea (aflibercept) 8 mg with extended 6-month treatment interval recommended for approval in EU – Bayer

Bayer announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion recommending a label extension for Eylea 8 mg (aflibercept 8 mg, 114.3 mg/ml solution for injection). This extension allows for expanded treatment intervals of up to 6 months for the treatment of two major retinal diseases, neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME) following approval by the European Commission. The decision of the European Commission is expected within the next few weeks and if approved, Eylea 8 mg would be the only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both nAMD and DME.

The CHMP opinion is based on positive three-year results from open-label extension studies of the pivotal clinical trials PULSAR, in nAMD and PHOTON, in DME. In both extension studies patients randomized to Eylea 8 mg at baseline maintained their visual and anatomic improvements, with 24% of patients in nAMD and 28% of patients in DME having a last assigned dosing interval of 6 months at the end of three years.

The safety profile of Eylea 8 mg continued to be favorable in the third year in both studies and is consistent with the well-established safety profile of Eylea 2 mg. The long-term safety data did not show any new signals in both trials, including for patients switching from Eylea 2 mg to Eylea 8 mg. The rates for ocular treatment emergent adverse events were similar across all treatment groups.