Shots:

• The P-III study involves assessing SB11 vs reference ranibizumab in monthly injections (0.5 mg) in 705 patients in a ratio (1:1) with nAMD while only 634 patients continued to receive treatment up to 48wks.
• One-year results from the P-III study demonstrated equivalence between SB11 and reference ranibizumab in patients with nAMD
• The study met its 1EPs i.e. changes from baseline in BCVA @8wks. and CST @4wks. The EMA has accepted for review the MAA of SB11 in Oct’2020

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 Ref:  Samsung Bioepis | Image: Samsung Bioepis