XSB-001 as efficacious as ranibizumab for improving visual acuity in nAMD patients
A study published in Ophthalmology Retina has concluded that XSB-001, administered every four weeks for managing nAMD patients, has equivalent efficacy to reference ranibizumab, as assessed by improvement in BCVA at Week 8. By week 52, researchers reported XSB-001 to be safe and tolerable.
This study entitled “Randomized Trial of Biosimilar XSB-001 Versus Reference Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration” was written by Loewenstein et al. and colleagues.
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
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