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news.Regeneron Pharmaceuticals and Bayer HealthCare have commenced a Phase 3 clinical trial to assess the efficacy and safety of Eylea (aflibercept) Injection in the neovascular form of age-related macular degeneration (wet AMD) in China.
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Eylea, also known 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.
The phase 3 clinical trial, SIGHT, led by Bayer will enroll nearly 300 patients.
The randomized, double-masked, trial will assess Eylea in treating wet AMD and its effect on improving vision when dosed as an intravitreal injection as compared with Photodynamic Therapy (PDT) with verteporfin.
Following the determination of primary endpoint at week 28, all patients will receive Eylea treatment until the end of the study at week 52.