Publications by authors named "Mercy Yeeun Kim"
Association of baseline factors with 1-year outcomes in the SB11-ranibizumab equivalence trial: A post hoc analysis.
Asia Pac J Ophthalmol (Phila)
June 2024
Purpose: To identify baseline factors associated with 1-year outcomes when treating neovascular age-related macular degeneration (nAMD) with ranibizumab biosimilar SB11 or reference ranibizumab (rRBZ), and to compare efficacy of the two products within subgroups judged to be clinically relevant.
Design: Post hoc analysis of a prospective, equivalence phase 3 randomized clinical trial (RCT) METHODS: 705 patients with nAMD were randomized 1:1 to receive SB11 or rRBZ for 48 weeks. Pooled and randomized groups were used to identify baseline factors associated with clinical outcomes at Week 52 using multiple linear regression models.
Article Synopsis
- The introduction of biologic medicines that target VEGF has greatly enhanced treatment outcomes for patients with retinal diseases, but their high costs can limit access to care.
- Biosimilars, which are cheaper alternatives that are proven to be clinically equivalent to branded agents, offer a potential solution to financial barriers in treatment.
- Since 2022, anti-VEGF biosimilars have begun to emerge in the US ophthalmology market, prompting a review of their regulatory background, development challenges, and the implications for patient care.
Importance: SB11 and reference ranibizumab (RBZ) are monoclonal anti-vascular endothelial growth factor (VEGF)-A antibodies approved for the treatment of neovascular age-related macular degeneration (nAMD) and other retinal diseases. The association of ranibizumab immunogenicity and treatment outcomes in patients with nAMD is unclear but relevant regarding concerns about immunogenicity of anti-VEGF biological products.
Objective: To examine the association of immunogenicity to ranibizumab products (SB11 and RBZ) with efficacy, safety, and pharmacokinetics.
Article Synopsis
- This study aimed to evaluate the long-term efficacy, safety, immunogenicity, and pharmacokinetics of the ranibizumab biosimilar SB11 compared to the original ranibizumab (RBZ) in patients with neovascular age-related macular degeneration (nAMD).
- Conducted as a multicenter, randomized, double-masked, parallel-group phase III equivalence trial with 705 participants, the study involved monthly intravitreal injections of either SB11 or RBZ and followed participants for 52 weeks.
- Results showed comparable visual outcomes, safety profiles, and immune responses between SB11 and RBZ, confirming that SB11 is a suitable alternative to RBZ in treating nAMD.