Samsung Bioepis announced that the primary endpoints have been met in the randomized, double-masked, phase 3 trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate, to reference ranibizumab in patients with wet age-related macular degeneration (AMD).
“We are excited to share this news on the development of our first treatment for ophthalmic diseases,” Seongwon Han, Medical Team Leader at Samsung Bioepis, said in a company news release. “These 24-week interim results suggest that SB11 will be a valuable treatment option for wet AMD, potentially helping millions of patients worldwide.”
The study achieved its primary endpoints which were the change from baseline in best corrected visual activity (BCVA) at week 8 and central subfield thickness (CST) a week 4. The least squares (LS) mean change in BCVA was 6.2 letters for SB11, compared with 7.0 letters for reference ranibizumab. The LS mean change in CST was −108.4 μm for SB11 vs −100.1 μm for reference ranibizumab. The confidence interval (CI) of the difference between the two treatments in BCVA and CST was within the predefined equivalence margins.
The incidence of treatment-emergent adverse events was 66.0% for SB11 and 66.9% for reference ranibizumab. The overall incidence of anti-drug antibodies was low (3.0% for SB11 vs 3.1% for reference ranibizumab). Pharmacokinetic (PK) serum concentrations also appeared comparable.
This data was to be presented at Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting 2020 which had been cancelled due to COVID-19.
Samsung Bioepis announced in November 2019 that it has entered into a new commercialization agreement with Biogen (Nasdaq: BIIB) for two ophthalmology biosimilar candidates, SB11 (ranibizumab) and SB15 (aflibercept), in the United States (US), Canada, Europe, Japan, and Australia.