The FINANCIAL — Bayer HealthCare’s collaboration partner, Regeneron Pharmaceuticals has received approval from the U.S. Food and Drug Administration for EYLEA Injection, known in the scientific literature as VEGF Trap-Eye, for the treatment of patients with neovascular age-related macular degeneration at a recommended dose of 2 milligrams every four weeks for the first 12 weeks, followed by 2 mg every 8 weeks.
“The approval of EYLEA is great news for patients in the U.S. suffering from wet AMD,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Chief Medical Officer. “This is an important milestone that further fuels our commitment to bring this new treatment option to wet AMD patients globally.”
The FDA approval of VEGF Trap-Eye is based upon the results of two Phase III clinical studies that demonstrated that VEGF Trap-Eye dosed every 8 weeks, following 3 initial injections every 4 weeks, showed comparable efficacy to Lucentis dosed every 4 weeks, for the primary endpoint of maintenance of visual acuity over 52 weeks. The most common adverse reactions reported in patients receiving VEGF Trap-Eye were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
Beyond the wet AMD indication, Phase III trials are currently under way with VEGF Trap-Eye in the treatment of central retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.
Bayer HealthCare and Regeneron are collaborating on the global development of VEGF Trap-Eye. Bayer HealthCare owns the exclusive marketing rights outside the United States, where the companies will share equally the profits from any future sales of VEGF Trap-Eye. Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States.
Bayer HealthCare has already submitted applications for marketing authorization in Europe, Japan, Australia and other countries for VEGF Trap-Eye for the treatment of wet AMD earlier this year.
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