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November 22, 2011

Regeneron Eylea injection wins FDA nod

The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals' Eylea (aflibercept) injection for the treatment of patients with neovascular (wet) age-related macular degeneration.

The US Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals’ Eylea (aflibercept) injection for the treatment of patients with neovascular (wet) age-related macular degeneration.

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 of the drug is 2mg, administered by intravitreal injection, once a month for three months, followed by 2mg once every two months.

The approval, awarded under a priority review, is backed by the results of two Phase III clinical studies, which demonstrated that the efficacy of Eylea was clinically equivalent to the ranibizumab.

Ophthalmic Consultants of Boston clinical ophthalmologist and retinal specialist Jeffrey Heier said that Eylea injections may reduce the need for costly and time-consuming office visits for patients and their caregivers.

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