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FDA Approves New Dose of Existing Drug to Treat Macular Degeneration

Approval of Eylea HD injection 8 mg means people taking the drug for wet age-related macular degeneration and other degenerative eye diseases may need eye injections less frequently.
  • Research News
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U.S. Department of Health and Human Services Food and Drug Administration sign.

Reviewed by Preeti Subramanian, PhD 

The FDA has approved a new, higher dose of Eylea®, called Eylea HD (aflibercept) Injection 8 mg, to treat wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. The higher dose means that people taking the drug may need injections less frequently to treat these conditions. The standard Eylea 2 mg treatment is still available. 

As with similar drugs, the standard Eylea 2 mg treatment is injected into the eye, initially every month and then every two months. The newly approved Eylea HD formulation may make it possible to extend the time between injections to once every four months for people with wet age-related macular degeneration.  

Eylea HD’s dosing regimen is as follows: every month for the first three months for all indications, followed by 8 mg every two to four months for people with wet age-related macular degeneration (AMD) and diabetic macular edema, and every two to three months for people with diabetic retinopathy. 

FDA approval for the high-dose regimen was based on results from two clinical trials, PULSAR and PHOTON, which enrolled more than 1,600 patients. The trials compared the 8 mg dose with the 2 mg dose and concluded that they were similar in safety and efficacy. The patients in the trials who received the higher and less frequent dose still experienced similar visual gains. 

Vision loss from wet AMD, diabetic macular edema, and diabetic retinopathy are all caused by the overgrowth of blood vessels that leak and bleed into the retina, the part of the retina responsible for sharp vision. Eylea and Eylea HD work by blocking vascular endothelial growth factor (VEGF), a protein that causes the growth of these abnormal blood vessels. 

Injections of Eylea HD are given in a doctor’s office. Patients receive anesthetic drops to numb the eye before receiving the injection. Side effects, which are uncommon, include cataracts, broken blood vessels in the eye, increased eye pressure, eye pain, eye irritation, blurred vision, floaters, vitreous detachment, damage to the outer layer of the cornea, and bleeding in the retina of the eye. 

Eylea is the brand name of the generic drug aflibercept. It was first approved by the FDA in 2011 and is manufactured by Regeneron Pharmaceuticals. 

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