FDA Approves Eylea HD (aflibercept) for nAMD, DME, Diabetic Retinopathy, and Macular Edema Following RVO

EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor.

EYLEA HD is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Macular Edema Following Retinal Vein Occlusion (RVO).

For ophthalmic intravitreal injection only, to be administered by a qualified physician. Requires specific injection components: a 5-micron sterile filter needle (18-gauge × 1½-inch), a 1-mL Luer lock syringe, and a 30-gauge × ½-inch sterile injection needle. For nAMD, DME, and DR: The recommended dose is 8 mg (0.07 mL of 114.3 mg/mL solution) administered every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg once every 8 to 16 weeks (+/- 1 week) for nAMD and DME, and every 8 to 12 weeks (+/- 1 week) for DR. For Macular Edema Following RVO: The recommended dose is 8 mg (0.07 mL of 114.3 mg/mL solution) administered every 4 weeks (approximately every 28 days +/- 7 days) for the first three to five doses, followed by 8 mg once every 8 weeks, +/- 1 week. For all indications: Some patients did not maintain a response with extended dosing intervals after successful response to the initial monthly doses. These patients may benefit from resuming every 4-week dosing.

Trial data not available in label.

Not reported in label.

Not reported in label.