Biosimilar FYB201 is Safe & Efficient in Neovascular Age-Rel
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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).

This was a prospective, multicenter, evaluation-masked, parallel-group, 48-week, phase III randomized study. A total of 477 patients were randomly assigned to receive FYB201 (n = 238) or reference ranibizumab (n = 239).

Patients received FYB201 or ranibizumab 0.5 mg by intravitreal injection in the study eye every 4 weeks.

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 prior to the third monthly intravitreal injection. Biosimilarity of FYB201 to its originator was assessed via a two-sided equivalence test, with an equivalence margin in BCVA of 3 ETDRS letters.

--BCVA improved in both groups, with a mean improvement of +5.1 (FYB201) and +5.6 (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 –0.4 ETDRS letters with a 90% confidence interval (CI) of –1.6 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.

Finally, in terms of clinical efficacy and ocular and systemic protection, FYB201 is biosimilar to reference ranibizumab in the care of patients with nAMD.