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.
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