FDA Approves 8 MG Dosing of Eylea for Wet AMD, Diabetic Macular Edema, and Diabetic Retinopathy

Regeneron, a global developer of biologic therapies, has announced that the US Food and Drug Administration (FDA) has approved 8 mg ocular injections of Eylea® (aflibercept) for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR). The new, higher dose —increased from 2 mg — means that patients require injections less frequently for treatment of these conditions. Eylea was first FDA-approved in 2011.

Regeneron says treatment frequency for 8 mg doses of Eylea are as follows:

• For Wet AMD and DME: Monthly treatment for the first 3 months followed by treatment every 2 to 4 months.
• For DR: Monthly treatment for the first 3 months followed by treatment every 2 months.

FDA approval for the new dosing regimen was based on results from two clinical trials that enrolled more than 1,600 patients combined. In the two trials, the new, higher dosing regimen with less frequent injection was similar in safety and efficacy to the previous dosing regimen of 2 mgs every 2 months (after 3 initial monthly doses).

Vision loss from wet AMD, DME, and DR are all caused by the growth of leaky blood vessels that lead to retinal cell and vision loss. Eylea works by blocking a protein called vascular endothelial growth factor (VEGF) which causes growth of leaky blood vessels.

Injections of Eylea are made into the vitreous, the soft gel-like substance in the middle of the eye. Injections are typically performed in an eye doctor’s office. Patients receive local anesthetic to minimize discomfort.