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

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:

• neovascular age-related macular degeneration
• anti-VEGF
• ranibizumab
• biosimilar ranibizumab

Consent to Participate

The authors confirm that all research participants provided informed consent for involvement in this study.

Acknowledgments

Dr Debasish Bhattacharya MS, Chairman, Disha Eye Hospitals, Kolkata, India

Disclosure

The authors report no conflicts of interest in this work.