SB15 biosimilar shows similar efficacy to reference aflibercept up to 56 weeks in nAMD

The proposed biosimilar SB15 is a clinically comparable alternative to reference aflibercept in treating neovascular age-related macular degeneration (nAMD), according to results of a Phase 3 clinical study presented at ASRS 2023.

The study, which assessed the efficacy, safety, immunogenicity, and pharmacokinetics (PK) of SB15, demonstrated comparable outcomes with aflibercept for up to 56 weeks in patients with neovascular age-related macular degeneration.

Previous findings reported at AAO 2022, established the equivalence of the primary endpoint, which measured the change from baseline in best-corrected visual acuity (BCVA) at Week 8 between SB15 and aflibercept. The latest results, extending the study up to 56 weeks, provide additional evidence supporting the clinical similarity of SB15 to the reference drug.

The randomized, double-masked, multicenter study involved 449 patients with nAMD who were divided into 2 groups. One group received 2 mg SB15 (n = 224) and the other aflibercept (n = 225) every 4 weeks for 3 consecutive intravitreal injections. From Week 32 onwards, patients were re-randomized to either continue their initial treatment (SB15/SB15 or aflibercept / aflibercept) or switch from aflibercept to SB15 (aflibercept /SB15) while being monitored for efficacy, safety, immunogenicity, and PK.

At the end of the 56-week study period, 425 patients completed the trial. The improvements in BCVA were found to be similar between the treatment groups. The mean BCVA letter change from baseline to Week 56 was 7.3 for SB15 versus 6.4 for aflibercept, and 7.9 for aflibercept /SB15 versus 7.5 for aflibercept / aflibercept. Anatomical outcomes were also comparable across all treatment groups.

The safety, immunogenicity, and PK profiles of SB15 were found to be similar to AFL throughout the study duration.

Reference
Sagong M. Phase III Randomized Clinical Trial Comparing SB15 With Reference Aflibercept in Neovascular Age-Related Macular Degeneration: 56-Week Results. Presented at: ASRS 41st Annual Meeting