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FDA approved Eylea HD (aflibercept) for nAMD, DME, Diabetic Retinopathy, and Macular Edema Following RVOFDA approved a new, higher-dose version of the eye medicine Eylea

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Key Takeaway
Consider extended 8-16 week dosing intervals after initial monthly loading doses for nAMD and DME.

The FDA has approved Eylea HD (aflibercept) for the treatment of four retinal vascular conditions: neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), diabetic retinopathy (DR), and macular edema following retinal vein occlusion (RVO). This approval provides a new high-dose formulation of the VEGF inhibitor aflibercept, with a recommended dose of 8 mg administered via intravitreal injection. The dosing regimen across indications involves an initial series of monthly loading doses, followed by extended maintenance intervals ranging from every 8 to 16 weeks, depending on the specific condition. This extended dosing schedule may offer a potential reduction in treatment burden for patients requiring long-term anti-VEGF therapy for these chronic retinal diseases.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

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

Indication & Patient Population

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).

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration (FDA) has approved a new version of the eye medicine Eylea, called Eylea HD. It is a higher-dose formulation of the drug aflibercept, which is given as an injection into the eye. It is approved to treat four conditions that can damage the retina and lead to vision loss: wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and swelling in the eye after a retinal vein blockage.

This medicine is for adults diagnosed with one of these specific retinal conditions. It works by blocking a protein that causes harmful, leaky blood vessels to grow in the back of the eye, which helps protect vision.

The approval provides a new treatment option. A key feature is that after the first few monthly doses, the maintenance injections can be given less frequently—potentially every 8 to 16 weeks, depending on the condition. For patients who need long-term treatment, this could mean fewer visits to the doctor's office over time.

It's important to remember that this is a new dosing option, not a cure. Every patient's situation is different. The most important step for anyone with these eye conditions is to talk with their own eye doctor. Only a doctor who knows your full medical history can determine if this new option is a suitable part of your care plan.

What this means for you:
A new, higher-dose eye medicine may allow for fewer injections for some patients.

Study Details

Study typeFda approval
PublishedAug 2023
View Original Abstract ↓
1 INDICATIONS AND USAGE EYLEA HD is indicated for the treatment of: EYLEA HD is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Diabetic Retinopathy (DR) ( 1.3 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.4 ) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Diabetic Retinopathy (DR) 1.4 Macular Edema Following Retinal Vein Occlusion (RVO)
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