Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence

Debdulal Chakraborty; Soumen Mondal; Subhendu Boral; Arnab Das; Tushar Kanti Sinha; Saptorshi Majumdar; Ranabir Bhattacharya; Ritobroto Maitra

doi:10.2147/OPTH.S407219

Biosimilar versus InnovAtor MoLecule of RAnibizumab in Neovascular Age-Related MaCular DEgeneration (The BALANCE Trial): Real-World Evidence

Clin Ophthalmol. 2023 Apr 8:17:1067-1076. doi: 10.2147/OPTH.S407219. eCollection 2023.

Authors

Debdulal Chakraborty¹, Soumen Mondal¹, Subhendu Boral¹, Arnab Das¹, Tushar Kanti Sinha¹, Saptorshi Majumdar¹, Ranabir Bhattacharya², Ritobroto Maitra³

Affiliations

¹ Department of Vitreoretinal Services, Disha Eye Hospitals, Kolkata, West Bengal, India.
² Department of MIS, Disha Eye Hospitals, Kolkata, West Bengal, India.
³ Radical Health Tech, New Delhi, India.

Abstract

Purpose: To analyse outcomes of innovator ranibizumab (IRM) (Lucentis) and biosimilar ranibizumab (BRM) (Razumab) in Indian eyes with neovascular age-related macular degeneration (nAMD).

Methods: Retrospective observational study in nAMD patients, who were treated with IRM or BRM (3 loading doses followed by pro re nata (PRN). Primary outcome measures were change in best corrected visual acuity (BCVA) and central macular thickness (CMT) along with safety analysis. Secondary outcomes measures were changes in the subretinal fluid (SRF) and intraretinal fluid (IRF).

Results: Inclusion criteria were satisfied in 164 eyes (60.74%). A total of 87 eyes were treated with IRM, and 77 eyes received BRM. Baseline BCVA was 0.57±0.27 logMAR in IRM group and 0.61±0.25 in the BRM group. At 3, 6, 9, and 12 months BCVA was 0.27±0.22 (p<0.0001), 0.34±0.23 (p<0.0001), 0.39±0.25 (p<0.0001), and 12 months 0.41±0.23 (p<0.0001) in the IRM group and 0.24±0.16 (p<0.0001), 0.27±0.16 (p<0.0001), 0.34±0.17 (p<0.0001), 0.38±0.18 (p<0.0001) in the BRM group. Baseline CMT was 420.39±54.45 μm in IRM group and 407.82±53.07 μm in BRM group. At 3, 6, 9, and 12 months, CMT decreased to 258.28±20.4 μm (p<0.0001), 268.38±19.5 μm (p<0.0001), 269.51±32.41 μm (p<0.0001), and 278.28±16.56 μm (p<0.0001) in the IRM group and 258.84±17.47 μm (p<0.0001), 265.69±17.29 μm (p<0.0001), 273.64±23.13 μm (p<0.0001), and 283.09±19.66 μm (p<0.0001) in the BRM group. Similar improvements in IRF and SRF levels in the patients were noted in both groups. Required number of doses of IRM and BRM was similar over the 12 month period in both groups. A similar profile of adverse events was noted in both the groups.

Conclusion: Intravitreal injection of IRM and BRM show similar efficacy and safety in Indian eyes with nAMD.

Keywords: anti-VEGF; biosimilar ranibizumab; neovascular age-related macular degeneration; ranibizumab.