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Phase 3 results presented at ARVO 2023 suggest a switch from aflibercept to SB15 led to no treatment-emergent issues such as loss of efficacy, increased adverse events, or increased immunogenicity.
New phase 3 findings suggest a proposed biosimilar aflibercept (SB15) demonstrated similar efficacy and safety compared with reference aflibercept up to 56 weeks in eyes with neovascular age-related macular degeneration (nAMD).1
The investigative team, led by SriniVas R. Sadda, MD, Doheny Eye Institute, suggests the switch from aflibercept to SB15 was not associated with treatment-emergent issues, including loss of efficacy, increased adverse events, or increased immunogenicity.
The research was presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting in New Orleans, Louisiana.
Previously, data showing the equivalence of the primary endpoint (change from baseline in best-corrected visual acuity [BCVA] at 8 weeks) and comparable efficacy, safety, immunogenicity, and pharmacokinetics up to 32 weeks between SB16 and aflibercept in nAMD was reported at the 2022 American Academy of Ophthalmology annual meeting. Sadda and colleagues presented the results from the study up to 56 weeks.
Within the randomized, double-masked, multicenter study, patients with nAMD were randomized 1:1 to either 2 mg SB15 (n = 224) or aflibercept (n = 225) every 4 weeks (q4w) for 3 consecutive intravitreal injections, followed by treatment every 8 weeks (q8w) through Week 48. At Week 32, patients were re-randomized to either continue their treatment regimen (SB15/SB15 or Aflibercept/Aflibercept) or switch from Aflibercept to SB15 (Aflibercept/SB15). Investigators assessed the efficacy, safety, immunogenicity, and PK up to Week 56.
Of 449 patients, 438 were re-randomized at Week 32, including 219 patients continuing SB15 (SB15/SB15), 108 patients continuing aflibercept (aflibercept/aflibercept; n = 108), and 111 patients switching from aflibercept to SB15 (aflibercept/SB15). Overall, a total of 425 patients completed 56 weeks of study.
The analysis showed the improvements in BCVA up to Week 56 were comparable between treatment groups during the study period. The least-squares mean BCVA letter change from baseline to Week 56 was 7.3 for SB15 (n = 224) compared to 6.4 for aflibercept (n = 113). Comparatively, the least-squares mean BCVA letter change was 7.9 for aflibercept/SB15 and 7.5 for aflibercept/aflibercept.
Sadda and colleagues noted comparability in anatomical outcomes was demonstrated in all treatment groups up to Week 56. Moreover, the safety, immunogenicity, and PK were comparable between SB15/SB15 and aflibercept/aflibercept, as well as between aflibercept/SB15 and aflibercept/aflibercept up to Week 56 after re-randomization at Week 32. Safety outcomes reported no new intraocular inflammation occurred or anti-drug antibodies developed after switching in the aflibercept/SB15 group.