A Multicenter, Retrospective Study (RE-ENACT 2) on Razumab™ (World's First Biosimilar Ranibizumab) in Retinal Vein Occlusion

• DOI: 10.1007/s40123-020-00277-3
• Publication Date: 2020-07-02T08:30:58Z
• Authors: Shashikant Sharma; ; Manjunath Bhaskar...; Sangita Jain; Hemanth Murthy; Naveenam Srinivas...; Raj Shri Hirawat; Aditya Sudhalkar; Amarendra Deka; Alay Banker; Vatsal Parikh; Manisha Agarwal; Charu Mithal; Rajender Pal Singh; Deepti Kulkarni; Abhishek Desai; Rushikesh Naigaonkar; Nishikant Borse; Simanta Pradeep S...; Atul Kumar Sahu; Shobhna Mange; Arup Chakraborty; Suprakash Roy; Valensha Surong; Mujtaba Khan; Alok Chaturvedi
• Keywords: Ophthalmology; 03 medical and health sciences; 0302 clinical medicine; Anti-VEGF; RVO; RE1-994; Biosimilar ranibizumab; Razumab; Retinal vein occlusion; Original Research; 3. Good health

The REal life assessmENt of safety And effeCTiveness of Razumab 2 (RE-ENACT 2) study evaluated the long-term effectiveness of biosimilar ranibizumab. We present the subgroup analysis of patients with retinal vein occlusion (RVO).Data of patients who received pro re nata (PRN) biosimilar ranibizumab (November 2015 to December 2018, 17 centers) were analyzed. Endpoints were change from baseline in best corrected visual acuity (BCVA, Snellen's/logMAR), central subfield thickness (CSFT), intraocular pressure (IOP), and proportions of patients having intraretinal fluid (IRF) and subretinal fluid (SRF) at weeks 4, 8, 12, 16, 20, 24, 30, 36, and 48.Of 101 patients, 48.51% were men, and the majority (79.21%) were treatment naïve and had received 3 (range 1-5) injections (53.5%). Significant improvements (P < 0.05) were observed from baseline to all timepoints for BCVA [baseline, 0.89 ± 0.06 (n = 94); week 48, 0.41 ± 0.08 (n = 14)] and CSFT [baseline, 527.58 ± 19.9 (n = 85); week 48, 307.47 ± 16.4 (n = 15)]. Changes in IOP (mmHg) were non-significant [baseline, 15.38 ± 0.4 (n = 94); week 48, 13.94 ± 0.6 (n = 16); P = 0.5575). Proportions of patients having IRF [baseline, 71.3% (n = 84) vs week 48, 0% (n = 15)] and SRF [baseline, 52.5% (n = 83) vs week 48, 0% (n = 15)] were decreased. Similar results for BCVA, CSFT, IOP, IRF, and SRF were observed for BRVO and CRVO subgroups. There were no new safety concerns.Biosimilar ranibizumab demonstrated improvements in visual acuity and disease outcomes up to 48 weeks in patients with RVO without any new safety concerns.