Regeneron Pharmaceuticals, Inc. (REGN) said Monday that the U.S. Food and Drug Administration has approved Eylea Injection for the treatment of Macular Edema following Retinal Vein Occlusion, which includes Macular Edema following Branch Retinal Vein Occlusion in addition to the previously-approved indication of Macular Edema following Central Retinal Vein Occlusion.
The recommended dosage of Eylea in patients with Macular Edema following Retinal Vein Occlusion is 2 milligrams every month.
Retinal Vein Occlusion occurs when there is an obstruction in a vein in the retina, the light-sensitive nerve tissue lining the back of the eye. The blockage causes a backup of blood and leads to poor blood supply in the affected retina. This results in the release of Vascular Endothelial Growth Factor, a naturally occurring protein in blood vessels that causes them to become leaky. The leaky vessels result in swelling in the center portion of the eye called the macula, which is the most common cause of vision impairment in RVO.
The expanded indication is based on the previously-approved indication for Macular Edema following Central Retinal Vein Occlusion and the positive results from the double-masked, randomized, controlled Phase 3 VIBRANT study of 181 patients with Macular Edema following Branch Retinal Vein Occlusion.
Eylea is available as a single, 2-mg strength intravitreal injection for all approved indications. Eylea is approved in the U.S. for the treatment of wet AMD, Macular Edema following RVO, and DME. In the EU and other countries, Eylea is approved for the treatment of wet AMD, Macular Edema following CRVO, and DME. Regulatory submissions have been made for EYLEA in the EU and other countries for Macular Edema following BRVO.
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