Chong Kun Dang Pharmaceutical Reports P-III Trials of CKD-701 (biosimilar, ranibizumab) for the Treatment of Neovascular Age-Related Macular Degeneration
Shots:
- The P-III trial evaluates CKD-701 vs ranibizumab in a ratio (1:1) in 312 patients with nAMD in 25 hospitals across Korea
- The results showed that CKD-701 has comparable clinical efficacy & safety with the reference Lucentis, 98.95% vs 98.62% patients had lost fewer than 15 letters of BCVA @3mos., no significant difference b/w groups in BCVA @6 & 12mos. The trial was published in PloS One
- The 2EPs of safety and immunogenicity were also comparable b/w groups improvement of 15 letters in BCVA @ 3/6/12mos. were 16%/22%/25% vs 17%/20%/21% decreased CRT at all time points with no significant differences’ b/w groups, AEs (51% vs 50%), SAEs (10% vs 10%), low cumulative incidence of ADAs was similar b/w groups @~12mos.
Ref: Centerforbiosimilar | Image: CKD Limited
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