FDA Approves Age-Related Macular Degeneration Drug

(Photos8.com)

The Food and Drug Administration approved the drug Eylea (aflibercept) to treat patients with neovascular age-related macular degeneration (AMD), also known as “wet” AMD. Regeneron Pharmaceuticals Inc. in Tarrytown, New York developed Eylea, in partnership with Bayer HealthCare in Germany.

Wet AMD is a leading cause of vision loss and blindness in Americans ages 60 and older. AMD affects the macula, the part of the eye that allows people to see fine detail needed to do daily tasks such as reading and driving. In the wet form of AMD, the growth of abnormal blood vessels can leak fluid into the central part of the retina, also known as the macula. When fluid leaks into the macula, the macula thickens and vision loss occurs.

Eylea is a human fusion protein, consisting of soluble vascular endothelial growth factor (VEGF) receptors 1 and 2, that binds all forms of VEGF-A along with the related placental growth factor.  The drug, known earlier as VEGF Trap-Eye, blocks all of these growth factors. The recommended dose by injection into the eye is 2 milligrams (mg) every four weeks for the first 12 weeks, followed by 2 mg every eight weeks.

The safety and efficacy of Eylea were tested in two randomized, multi-center, double-masked, active-controlled clinical trials — VIEW 1 and VIEW 2 — in patients with wet AMD.  A total of 2,412 patients were treated and evaluated for efficacy, 1,817 with EYLEA. Science Business reported on those trials in November 2010.

People in the study received either Eylea or Lucentis (ranibizumab injection). Eylea was given every four or eight weeks, while Lucentis was administered every four weeks. The primary endpoint in each study was a patient’s visual acuity after one year of treatment. The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual acuity.

The most common side effects in patients receiving Eylea, according to FDA, were eye pain, blood at the injection site (conjunctival hemorrhage), the appearance of floating spots in a person’s vision (vitreous floaters), clouding of the eye lens (cataract), and an increase in eye pressure.

Read more: Macular Degeneration Drug Achieves Goal in Clinical Trial

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