Sandoz’ Biosimilar Aflibercept Meet Primary Endpoints in the P-III Study (MYLIGHT) for the Treatment of Wet Macular Degeneration
Shots:
- The P-III trial (MYLIGHT) evaluating the efficacy and safety study of biosimilar aflibercept vs Eylea in a ratio (1:1) in 485 patients across 16 countries for 48wk., followed by a safety follow-up period of 4wks.
- The study met its primary efficacy & showed therapeutic equivalence in mean change of BCVA from baseline to 8wk. b/w biosimilar aflibercept and Eylea while the safety, immunogenicity, and PK results further confirmed no clinical difference
- The company plans to file for regulatory approval for biosimilar aflibercept in the US and EU in the coming months & has 8 marketed biosimilars with 24 assets in various stages of development
Ref: Novartis | Image: Sandoz
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