XSB-001 as efficacious as ranibizumab for improving visual acuity in nAMD patients

In this study, researchers evaluated the efficacy, safety, and immunogenicity of a ranibizumab biosimilar candidate (XSB-001) versus a reference product (Lucentis®) for neovascular age-related macular degeneration (nAMD) in Phase 3, multicenter, randomized, double-masked, parallel-group study.

The Eligible patients were randomized to intravitreal injections of XSB-001 or reference ranibizumab (0.5 mg ) in the study eye once every four weeks for a duration of 52 weeks. The Primary endpoint was changed from baseline in best-corrected visual acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letters at Week 8.

The study results are as follows:

• There were 582 patients.
• The XSB-001 and reference ranibizumab had 292 and 290 patients, respectively, with a mean age of 74.1 years.
• The mean BCVA score at baseline was 61.7 and 61.5 ETDRS letters in the XSB-001 and reference ranibizumab groups, respectively.
• At Week 8, the LS mean change in BCVA from baseline was 4.6 ETDRS letters in the XSB-001 group and 6.4 letters in the reference ranibizumab group.
• At Week 52, LS mean change in BCVA was 6.4 and 7.8 letters, respectively.
• There were no clinically meaningful differences between treatments in anatomical, safety, or immunogenicity endpoints through Week 52.

They said, “XSB-001 demonstrated biosimilarity to reference ranibizumab in nAMD patients.

They said that treatment with XSB-001 for 52 weeks is safe and well tolerated with a safety profile similar to the reference product.

Further reading:

https://www.sciencedirect.com/science/article/pii/S246865302300204X?via=ihub