STADA and Xbrane Report P-III Study Results of Ximluci (biosimilar, ranibizumab) for the Treatment of Neovascular Age-Related Macular Degeneration
Shots:
- The P-III study evaluating XSB-001 (IVT) vs reference ranibizumab (0.5mg) in a ratio (1:1) in 582 patients with nAMD across 15 countries incl. the US
- The results showed biosimilarity to reference ranibizumab & the treatment with XSB-001 for 52wks. was safe & well tolerated with a safety profile similar to the reference ranibizumab. The study met its 1EPs i.e., the mean BCVA score at baseline was 61.7 vs 61.5 ETDRS letters, and the LS mean change in BCVA from baseline was 4.6 vs 6.4 ETDRS letters at 8wk.
- At 52wk., LS mean (SE) change in BCVA was 6.4 vs 7.8 letters with no clinical differences b/w treatments in anatomical, safety, or immunogenicity EPs, 4% vs 3% were positive for ADAs, and 11% vs 13% were positive at 52wk.
Ref: Center For Biosimilar | Image: STADA
Related News:- STADA and Xbrane Receives the MHRA’s Approval for Ximluci (biosimilar, ranibizumab) to Treat Retinal Diseases
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
