Multimodal Imaging Can Help Assess Retinopathy

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Efficacy and Safety of Biosimilar FYB201
Compared with Ranibizumab in Neovascular
Age-Related Macular Degeneration
Frank G. Holz, MD,1 Piotr Oleksy, MD,2 Federico Ricci, MD,3 Peter K. Kaiser, MD,4 Joachim Kiefer, PhD,5
Steffen Schmitz-Valckenberg, MD,1,6 for the COLUMBUS-AMD Study Group*
Purpose: This trial was conducted to investigate the clinical equivalence of the proposed biosimilar FYB201
and reference ranibizumab in patients with treatment-naive, subfoveal choroidal neovascularization caused by
neovascular age-related macular degeneration (nAMD).
Design: This was a prospective, multicenter, evaluation-masked, parallel-group, 48-week, phase III randomized study.
Participants: A total of 477 patients were randomly assigned to receive FYB201 (n ¼ 238) or reference
ranibizumab (n ¼ 239).
Methods: Patients received FYB201 or reference ranibizumab 0.5 mg by intravitreal (IVT) injection in the
study eye every 4 weeks.
Main Outcome Measures: The primary end point was change from baseline in best-corrected visual acuity
(BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at 8 weeks before the third monthly IVT
injection. Biosimilarity of FYB201 to its originator was assessed via a 2-sided equivalence test, with an equivalence margin in BCVA of 3 ETDRS letters.
Results: The BCVA improved in both groups, with a mean improvement of þ5.1 (FYB201) and þ5.6
(reference ranibizumab) ETDRS letters at week 8. The analysis of covariance (ANCOVA) least squares mean
difference for the change from baseline between FYB201 and reference ranibizumab was e0.4 ETDRS letters with
a 90% confidence interval (CI) of e1.6 to 0.9. Primary end point was met as the 90% CI was within the predefined
equivalence margin. Adverse events were comparable between treatment groups.
Conclusions: FYB201 is biosimilar to reference ranibizumab in terms of clinical efficacy and ocular and
systemic safety in the treatment of patients with nAMD. Ophthalmology 2022;129:54-63 ª 2021 by the American
Academy of Ophthalmology. This is an open access article under the CC BY-NC-ND license