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

Written By : Aditi |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2023-06-10T08:45:23+05:30 | Updated On 10 Jun 2023 4:23 PM IST

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.

BDS, MDS in Periodontics and Implantology

Dr. Aditi Yadav is a BDS, MDS in Periodontics and Implantology. She has a clinical experience of 5 years as a laser dental surgeon. She also has a Diploma in clinical research and pharmacovigilance and is a Certified data scientist. She is currently working as a content developer in e-health services. Dr. Yadav has a keen interest in Medical Journalism and is actively involved in Medical Research writing.

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751