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EYLEA® HD (aflibercept) Injection 8 mg

We are pleased to announce that EYLEA HD has received
FDA approval for MEfRVO.

This approval:

Expands the EYLEA HD indications to include Wet AMD, DME, DR, and MEfRVO

Introduces the option for Q4W dosing for appropriate patients across indications, allowing for greater flexibility in treatment intervals

Dosing and administration

Wet AMD and DME: The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first 3 doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week. Some patients did not maintain a response with extended dosing intervals after successful response to the 3 initial monthly doses. These patients may benefit from resuming every-4-week dosing (approximately every 28 days +/- 7 days).

DR: The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first 3 doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 12 weeks, +/- 1 week. Some patients did not maintain a response with extended dosing intervals after successful response to the 3 initial monthly doses. These patients may benefit from resuming every-4-week dosing (approximately every 28 days +/- 7 days).

MEfRVO: The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first 3 to 5 doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 weeks, +/- 1 week. Some patients did not maintain a response with extended dosing intervals after successful response to the first 3 to 5 initial monthly doses. These patients may benefit from resuming every-4-week dosing (approximately every 28 days +/- 7 days).

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
•	EYLEA HD is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, or known hypersensitivity to aflibercept or any of the excipients in EYLEA HD.
WARNINGS AND PRECAUTIONS
•	Intravitreal injections, including those with aflibercept, have been associated with endophthalmitis and retinal detachments and, more rarely, retinal vasculitis with or without occlusion. Proper aseptic injection technique must always be used when administering EYLEA HD. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
•	Acute increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with EYLEA HD. Sustained increases in IOP have also been reported after repeated intravitreal dosing with VEGF inhibitors. IOP and the perfusion of the optic nerve head should be monitored and managed appropriately.
•	There is a potential risk of arterial thromboembolic events (ATEs) following intravitreal use of VEGF inhibitors, including EYLEA HD. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The incidence of reported ATEs in the Wet AMD study from baseline through week 48 was 0.4% (3 out of 673) in the combined group of patients treated with EYLEA HD compared with 1.5% (5 out of 336) in patients treated with EYLEA 2 mg. The incidence in the DME study from baseline to week 48 was 3.1% (15 out of 491) in the combined group of patients treated with EYLEA HD compared with 3.6% (6 out of 167) in patients treated with EYLEA 2 mg. The incidence in the RVO study from baseline to week 36 was 0.5% (3 out of 591) in the combined group of patients treated with EYLEA HD compared with 1.7% (5 out of 301) in patients treated with EYLEA 2 mg.
ADVERSE REACTIONS
•	The most common adverse reactions (≥3%) reported in patients receiving EYLEA HD were cataract, conjunctival hemorrhage, corneal epithelium defect, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, retinal hemorrhage, vision blurred, vitreous detachment, and vitreous floaters.
•	Patients may experience temporary visual disturbances after an intravitreal injection with EYLEA HD and the associated eye examinations. Advise patients not to drive or use machinery until visual function has recovered sufficiently.
INDICATIONS
EYLEA HD^® (aflibercept) Injection 8 mg is indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Macular Edema following Retinal Vein Occlusion (RVO).
Please click here for full Prescribing Information for EYLEA HD.

AMD = age-related macular degeneration; DME = diabetic macular edema; DR = diabetic retinopathy; MEfRVO = macular edema following retinal vein occlusion; Q4W = every 4 weeks.

Reference: EYLEA HD full U.S. Prescribing Information. Regeneron Pharmaceuticals, Inc. November 2025.

For Colorado Prescribers – Click Here for Pricing Information

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