Publications by authors named "Jan Hamouz"
Article Synopsis
- This study evaluated the effectiveness of a biosimilar drug, QL1205, compared to the established drug ranibizumab (Lucentis®) in patients with neovascular age-related macular degeneration (nAMD) through a rigorous phase 3 trial.* -
- A total of 616 treatment-naïve patients were randomly assigned to receive either QL1205 or ranibizumab, and both groups were given injections every four weeks for 48 weeks, with the main focus on changes in best-corrected visual acuity (BCVA).* -
- Results showed similar improvements in visual acuity for both QL1205 (+6.3 letters) and ranibizumab (+7.
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.
Importance: Neovascular age-related macular degeneration is the leading cause of blindness in individuals 50 years or older. The availability of a ranibizumab biosimilar product (SB11) may facilitate access to an effective alternative to this treatment.
Objective: To demonstrate equivalence of efficacy, similar safety, and similar immunogenicity of SB11 compared with the reference ranibizumab.