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FDA Approves Eylea for Eye Disorder in Older People?

The drug Eylea has been approved by the U.S. Food and Drug Administration to treat patients with the wet form of age-related macular degeneration, a leading cause of blindness and vision loss in Americans ages 60 and older.

Age-related macular degeneration, or AMD, gradually destroys a person’s sharp, central vision. It affects the macula, that part of the eye that enables people to see the smallest of details needed to do such everyday tasks as reading and driving.

There is a wet form and dry form of AMD. The growth of abnormal blood vessels in the eye causes the wet form of AMD as these blood vessels can leak fluid into the macula, which is the central part of the retina. When this occurs, the macula thickens and vision loss occurs. Straight lines appearing to be wavy is an early symptom of wet AMD.

Dr. Edward Cox, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research said Eylea is a significant new treatment option for wet AMD. Because this is a potentially blinding disease, new treatment options like this are important.

The effectiveness and safety of Eylea was evaluated in two clinical trials involving 2,412 adult patients. People in the study received either Eylea (aflibercept) or Lucentis (ranibizumab injection). The main endpoint in each study was a patient’s clearness of vision after a year of treatment.

An ophthalmologist injects Eylea into a patient’s eye every four weeks or every eight weeks. The studies demonstrated that Eylea was as effective as Lucentis in improving or maintaining visual acuity.

The most commonly reported side effects in patients receiving Eylea included
Eye pain, blood at the injection site, clouding of the eye lens, the appearance of floating spots in a person’s vision, and an increase in eye pressure were the most commonly reported side effects from patients receiving Eylea.

According to the FDA, the drug Eylea should not be used in patients who have an active eye infection or active ocular inflammation. Eylea has not been studied in pregnant women, so the treatment should be used only in those patients if the potential benefits of the treatment outweigh any potential risks.

Eylea is now added to the list of FDA-approved treatment options for wet AMD: Lucentis (ranibizumab injection) approved in 2006, Macugen (pegaptanib sodium injection) approved in 2004, and Visudyne (verteporfin for injection) approved in 2000.

For more on medical safety issues, see the library of articles by Daytona Beach nursing home injury attorney.

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