Ranibizumab Biosimilar Shows Similar Efficacy through 48 Weeks

Prof. Frank Holz

A biosimilar to reference ranibizumab is capable of benefitting treatment-naïve patients with subfoveal neovascular age-related macular degeneration (nAMD), according to newly presented data.

In research shared at the American Academy of Ophthalmology (AAO) 2020 Virtual Meeting this weekend, investigators reported proposed biosimilar FYB201, in reference to anti-vascular endothelial growth factor (anti-VEGF) ranibizumab, was capable of achieving primary endpoints in best corrected visual acuity (BCVA) as well as key secondary endpoints in patients previously untreated for subfoveal nAMD.

An international team of investigators, led by Professor Frank G. Holz, Professor and Chair of the Department of Ophthalmology at the University of Bonn in Germany, sought to compare the efficacy and safety of FYB201 in this indicated patient population versus reference ranibizumab.

Ranibizumab (Lucentis) was originally approved for wet AMD in 2006, and has since been indicated for a series of uses in treating patients with either AMD or diabetic macular edema.

Holz and colleagues randomized 429 patients to either FYB201 (n = 215) or reference ranibizumab (n = 214). Each dose was 0.5 mg, administered every 4 weeks for 48 weeks.

The investigators sought a primary endpoint of 95% confidence interval (CI) within -3.5 to 3.5 for difference in mean change from baseline to BCVA at 8 weeks across the treatment arms. Key secondary endpoints included optical coherence tomography (OCT) and fluorescein angiography parameters, as well as an interpretation of the pharmacokinetics, immunogenicity and safety associated with FYB201.

At 8 weeks, investigators observed a mean change from baseline BCVA of plus 5.2 letters on the EDTRS Test for patients treated with FYB201; among patients receiving reference ranibizumab, improvement was plus 6.0 (difference, -0.8; 95% CI, -2.3 to 0.9).

Holz and colleagues also observed a similar efficacy maintained among biosimilar-treated patients at 48 weeks, versus reference ranibizumab (+7.9 letters vs +8.5 letters, respectively.

They also reported a similarity in secondary endpoints of safety, immunogenicity, and pharmacokinetics between the treatment arms.

Overall, they concluded FYB201 showed similar efficacy endpoints and safety profile to reference ranibizumab among patients with treatment-naïve nAMD.

The study, “COLUMBUS-AMD: Efficacy and Safety of FYB201, a Proposed Biosimilar to Ranibizumab, in nAMD,” was presented at AAO 2020.