FDA Approves Higher Dose of Eylea for Eye Disease Treatment

The U.S. Food and Drug Administration (FDA) has approved a higher dose version of Regeneron Pharmaceuticals' drug Eylea for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and diabetic retinopathy (DR). The higher dose, known as Eylea HD, is priced at $2,625 per single-use vial in the U.S. and has been shown to be as effective as the lower dose version in late-stage trials. The FDA had previously declined to approve the higher dose version due to outstanding questions regarding a third-party manufacturer, but those issues have now been addressed.