The European Commission (EC) Approves Eylea 8 mg for Extended Treatment Intervals of Up to 6 Months

The European Commission (EC) has granted a label extension in the European Union (EU) for Eylea 8 mg with extended treatment intervals of up to 6 months for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Eylea 8 mg was previously approved for administration at extended treatment intervals of up to every 4 months, following 3 initial monthly doses. Eylea 8 mg is the first and only anti-vascular endothelial growth factor (VEGF) treatment in the EU with treatment intervals of up to 6 months for both patients with wet AMD and DME.

The EC decision is based on additional positive results from the third year open-label extension phase of the pivotal clinical trials PULSAR in wet AMD and PHOTON in DME. In both extension phases (study weeks 96-156), patients originally randomized to Eylea 8 mg at week 0 maintained their visual and anatomic improvements, with 24% of patients in wet AMD and 28% of patients in DME having a last assigned dosing interval of 6 months at the end of 3 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 at week 96. The rates for ocular treatment emergent adverse events were similar across all treatment groups.

Eylea 8 mg (aflibercept 8 mg) has been approved to date in more than 60 markets for the treatment of wet AMD and DME. Further regulatory applications for Eylea 8 mg in additional markets are ongoing.

Eylea 8 mg (aflibercept 8 mg; in the United States: Eylea HD) is being jointly developed by Bayer and Regeneron. Regeneron maintains exclusive rights to Eylea 2 mg (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 2 mg and Eylea 8 mg.