Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) to Treat Neovascular Age-Related Macular Degeneration
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The US FDA has approved Enzeevu, biosimilar version of Eylea (aflibercept), 2mg vial kit & pre-filled syringe for intravitreal injection for enhanced & sustained visual acuity among neovascular age-related macular degeneration (nAMD) patients
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Approval was supported by the analytical & preclinical in vitro results plus data from Mylight trial, assessing Enzeevu (aflibercept-abzv) vs Eylea in nAMD patients (n=485) for 52wks., that demonstrated similar efficacy, safety & immunogenicity b/w Enzeevu & Eylea
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Enzeevu, a recombinant fusion protein, inhibits abnormal vessel growth by binding with VEGF-A & PlGF. It is injected into the eye among nAMD patients for enhancing visual acuity & slowing disease progression
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