A Multicenter, Retrospective Study (RE-ENACT 2) on the Use of Razumab™ (World’s First Biosimilar Ranibizumab) in Wet Age-Related Macular Degeneration

• DOI: 10.1007/s40123-019-00228-7
• Publication Date: 2019-12-27T10:02:43Z
• Authors: Shashikant Sharma; Mujtaba Khan; Alok Chaturvedi
• Keywords: Biosimilar

The REal life assessmENt of safety And effeCTiveness Razumab (RE-ENACT) and long-term RE-ENACT 2 retrospective studies have evaluated the use Razumab™ (world's first biosimilar ranibizumab) in retinal disorders Indian patients. This report presents subgroup analysis from study patients with wet age-related macular degeneration (wet AMD).Medical charts administered ranibizumab injections as PRN treatment regimen between September 2015 June 2018, at 17 centers across India, were reviewed. Changes baseline best-corrected visual acuity (BCVA, based on Snellen's or logMAR chart), central subfield thickness (CSFT), intraocular pressure (IOP), proportions having intraretinal fluid (IRF) subretinal (SRF) weeks 4, 8, 12, 16, 20, 24, 30, 36, 48 evaluated.Of 103 AMD, 62.1% men majority (74.8%) naïve. (57.9%) had received 3 (range 1-5) injections. Significant improvements observed to all timepoints for BCVA (baseline, 0.92 ± 0.6 [n = 94]; week 48, 0.51 0.4 14]; P 0.0014) CSFT 430.83 14.4 85]; 301.26 11.6 15]; < 0.0001). IOP minimal not significant (14.92 3.2 94] vs. 14.50 2.1 18]; 0.9068). A decrease IRF 63.6% 99] 15% 20]) SRF 82.3% 96] 5% also observed. Similar results occult classic subgroups. There no new concerns.Razumab (biosimilar demonstrated disease outcomes without issues.