Eylea HD FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 22, 2023.
FDA Approved: Yes (First approved August 18, 2023)
Brand name: Eylea HD
Generic name: aflibercept
Dosage form: Injection
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy
Eylea HD (aflibercept) is a higher dose formulation of the approved vascular endothelial growth factor (VEGF) inhibitor aflibercept indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and diabetic retinopathy (DR).
- nAMD is a retinal disease that occurs when abnormal blood vessels grow and leak fluid under the macula, the part of the eye responsible for sharp central vision and seeing fine detail. DR is an eye disease characterized by microvascular damage to the blood vessels in the retina often caused by poor blood sugar control in people with diabetes. DME can occur at any stage of DR as the blood vessels in the retina become increasingly fragile and leak fluid, potentially causing visual impairment.
- Eylea HD contains aflibercept, a VEGF inhibitor that works by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved in angiogenesis. Eylea HD works to treat nAMD, DME and DR by blocking the growth of new blood vessels and decreasing the ability of fluid to pass through blood vessels (vascular permeability) in the eye.
- Aflibercept was first approved as a 2 mg/0.05 mL injection by the FDA under the brand name Eylea in 2011. Eylea is administered by intravitreal injection every 4 weeks for the first three months then once every 8 weeks for nAMD, and every 4 weeks for the the first 5 injections then once every 8 weeks for DME and DR.
- Eylea HD is a higher dose formulation containing aflibercept 8 mg/0.07 mL. Eylea HD is FDA approved for the treatment of nAMD, DME and DR, while Eylea is approved for nAMD, DME, DR and also macular edema following retinal vein occlusion (RVO) and retinopathy of prematurity (ROP).
- Eylea HD is administered by intravitreal injection every 4 weeks for the first three doses then once every 8 to 16 weeks for nAMD and DME, and every 4 weeks for the first three doses then once every 8 to 12 weeks for DR.
- FDA approval for Eylea HD was based on results of the pivotal PULSAR and PHOTON trials in which Eylea HD demonstrated clinically equivalent vision gains to Eylea, and were maintained with fewer injections.
- Warnings and precautions associated with Eylea HD include eendophthalmitis and retinal detachment, increases in intraocular pressure, and a potential risk of arterial thromboembolic events.
- Common adverse reactions include cataract, conjunctival hemorrhage, intraocular pressure increased, ocular discomfort/eye pain/eye irritation, vision blurred, vitreous floaters, vitreous detachment, corneal epithelium defect, and retinal hemorrhage.
Development timeline for Eylea HD
Further information
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