Biosimilar SB11 versus reference ranibizumab in neovascular age-related macular degeneration: 1-year phase III randomised clinical trial outcomes.

ABSTRACT:

Background/aims

To provide longer-term data on efficacy, safety, immunogenicity and pharmacokinetics (PK) of ranibizumab biosimilar SB11 compared with the reference ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).

Methods

Setting: Multicentre. Design: Randomised, double-masked, parallel-group, phase III equivalence study. Patient population: ≥50 years old participants with nAMD (n=705), one 'study eye'.

Intervention

1:1 randomisation to monthly intravitreal injection of 0.5 mg SB11 or RBZ. Main outcome measures: Visual efficacy endpoints, safety, immunogenicity and PK up to 52 weeks.

Results

Baseline and disease characteristics were comparable between treatment groups. Of 705 randomised particip

SUBMITTER: Bressler NM 

PROVIDER: S-EPMC9985746 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature