Alteogen’s Eyluxvi (Biosimilar, Eylea) Receives the CHMP’s Positive Opinion for Retinal Diseases
Shots:
- The CHMP has recommended Eyluxvi (ALT-L9), a biosimilar version of Eylea (aflibercept), to treat wet AMD, visual impairment due to macular oedema secondary to branch/central retinal vein occlusion & visual impairment due to diabetic macular oedema & myopic choroidal neovascularisation
- Opinion was based on extensive analytical, non-clinical, & clinical data incl. a P-III trial assessing ALT-L9 (n = 216) vs Eylea (n = 215) in 431 wet AMD pts, which showed similar efficacy, safety, immunogenicity, & PK between the two
- Eyluxvi is a fusion protein that blocks VEGF-A & PIGF from binding to VEGFR-1/2 to reduce neovascularization & vascular permeability, thereby slowing vision loss in retinal diseases
Ref: PRNewsWire | Image: Alteogen | Press Release
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