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FDA approves Regeneron Eylea injection

Regeneron Pharmaceuticals' Eylea (aflibercept) injection, for the treatment of patients with neovascular (wet) Age-related Macular Degeneration (AMD), has earned FDA approval.

Eylea is a recombinant fusion protein, that binds VEGF-A and placental growth factor (PlGF) to inhibit the binding and activation of these cognate VEGF receptors.

The recommended dose for Eylea injection is 2 mg administered by intravitreal injection every four weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every eight weeks (2 months).

Two Phase 3 clinical studies – View 1 and View 2, which proved the efficacy of Eylea in being clinically equivalent to the ranibizumab, led to the approval.