Regeneron Pharmaceuticals, Inc. (REGN) Friday said the U.S. Food and Drug Administration has approved EYLEA (aflibercept) injection for the treatment of patients with neovascular (wet) Age-related Macular Degeneration or AMD.
Regeneron said EYLEA is the only FDA-approved treatment for wet AMD labeled for less than monthly dosing that demonstrated clinical equivalence to the monthly standard of care.
AMD is a leading cause of acquired blindness. Macular degeneration is diagnosed as either dry or wet. In wet AMD, new blood vessels grow beneath the retina and leak blood and fluid. This leakage causes disruption and dysfunction of the retina creating distortion and/or blind spots in central vision. Wet AMD is the leading cause of blindness for people over the age of 65 in the U.S. and Europe.
The recommended dose for EYLEA is 2 mg administered by intravitreal injection every four weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every eight weeks (2 months).
The approval of EYLEA was granted under a Priority Review, a designation that is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.
Regeneron is collaborating with Bayer HealthCare on the global development of EYLEA. Bayer submitted an application for marketing authorization in Europe for wet AMD in June 2011.
Bayer HealthCare will market EYLEA outside the United States, where the companies will share equally the profits from any future sales of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States.
The FDA approval was based upon the results of two Phase 3 clinical studies. In the studies, EYLEA dosed every eight weeks, following three initial monthly injections, was clinically equivalent to the standard of care, Lucentis (ranibizumab injection) dosed every four weeks. The performance was measured by the primary endpoint of maintenance of visual acuity (less than 15 letters of vision loss on an eye chart) over 52 weeks.
Adverse event profile was similar to that seen with ranibizumab.
EYLEA, known in the scientific literature as VEGF Trap-Eye, is a recombinant fusion protein, consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration.
Vascular Endothelial Growth Factor or VEGF is a naturally occurring protein in the body. Its normal role in a healthy organism is to trigger formation of new blood vessels (angiogenesis) supporting the growth of the body's tissues and organs.
However, in certain diseases, such as wet age-related macular degeneration, it is also associated with the growth of abnormal new blood vessels in the eye, which exhibit abnormal increased permeability that leads to edema. It often results in Scarring and loss of fine-resolution central vision.
REGN closed Friday's regular trading at $49.81, up $1.32 or 2.58%, on the Nasdaq. In after-hours, the stock gained $0.54 or 1.08%.
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