Shots:
- The US FDA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept), to treat neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), & diabetic retinopathy
- Approval was supported by extensive analytical, non-clinical, & clinical data, incl. a P-III trial in DME pts (n=348) comparing Eydenzelt vs Eylea over 52wks., which met its 1EP of change in best corrected visual acuity at Wk. 8, along with 2EPs of comparable efficacy, safety, & immunogenicity
- Eydenzelt is a fusion protein that blocks VEGF-A & PIGF to reduce neovascularization & vascular permeability, thereby slowing vision loss in retinal diseases
Ref: Celltrion | Image: Celltrion| Press Release
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