NOTICE: The reference product, Lucentis®, updated the Warnings and Precautions section of its labeling. Samsung Bioepis, in partnership with Biogen, is working with the FDA to evaluate the BYOOVIZ® (ranibizumab-nuna) labeling.
BYOOVIZ DEMONSTRATED A COMPARABLE SAFETY PROFILE TO LUCENTIS1,2
Summary of All Adverse Events up to Week 52 (Safety Set)2*
AE Summary
BYOOVIZ (n=350) n (%)
Lucentis (n=354) n (%)
TEAEs
Serious ocular AE in the study eye
(by preferred item)
Serious nonocular AE (occurrence ≥0.5% in
either treatment group; by preferred item)
AESI†
TEAEs leading to IP discontinuation
Deaths
Adapted from Bressler NM, et al., 2021.
Percentages are based on the number of participants in the safety set.
*
Included participants receiving at least one dose during the study period after randomization.
†
The most frequently reported adverse events of special interest were intraocular pressure increase (BYOOVIZ: 0.3%, n=1; Lucentis: 1.7%, n=6) and iridocyclitis (BYOOVIZ: 0.9%, n=3; Lucentis: 0%, n=0).
Additional safety, immunogenicity, and pharmacokinetic‡ (PK) outcomes were comparable between treatment groups1 up to Week 52 of treatment2
‡
PK data were obtained in 54 patients and have limitations in their interpretation. Absorption of intravitreal injection anti-VEGF product into systemic circulation is very limited.
AE=adverse event; AESI=adverse event of special interest; SAE=serious adverse event; TEAE=treatment-emergent adverse event; VEGF=vascular endothelial growth factor.