The phase 3 trial evaluating SB15, a treatment for neovascular age-related macular degeneration (nAMD), has shown promising results.
The study compared the efficacy, safety, pharmacokinetics, and immunogenicity of SB15 to the reference drug aflibercept (AFL) and also assessed the outcomes of switching from AFL to SB15. The results indicate that SB15 is comparable to AFL in terms of efficacy, safety, and other key parameters. Additionally, the trial suggests that switching from AFL to SB15 is well-tolerated and does not compromise the treatment’s effectiveness.
The trial enrolled a total of 449 participants with nAMD, randomly assigning them to receive either SB15 (224 participants) or AFL (225 participants). At week 32, participants were further divided into groups: continuing on SB15 (SB15/SB15, N = 219), continuing on AFL (AFL/AFL, N = 108), or switching from AFL to SB15 (AFL/SB15, N = 111).
The 1-year results revealed comparable efficacy between SB15 and AFL. The change in best-corrected visual acuity (BCVA) from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL, with a negligible difference (0.4 letters, 95% CI: -2.5 to 3.2). Similar trends were observed in changes from baseline to week 56 in central subfield thickness and total retinal thickness, with no significant differences between the 2 groups.
Furthermore, participants who switched from AFL to SB15 (AFL/SB15) showed comparable BCVA changes to those who continued on AFL (AFL/AFL). Safety, PK, and immunogenicity profiles were also consistent across groups, indicating that switching from AFL to SB15 did not compromise these parameters.
Reference
Woo SJ, Sadda SR, Bradvica M, et al. Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial. BMJ Open Ophthalmol. 2023;8(1):e001561. doi: 10.1136/bmjophth-2023-001561. PMID: 38114333.
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