DOI: 10.4103/josb.josb_13_26 ISSN: 3050-5313

Retrospective Evaluation of Switching from Aflibercept to Biosimilar Ranibizumab: A Multicenter Real-world Study

Debdulal Chakraborty, Tushar Kanti Sinha, Arnab Das, Subhendu Boral, Angshuman Mukherjee, Ranabir Bhattacharya, Dinesh Rungta, Shouvick Dan, Asmita Saha, Mrinmoy De, Sourav Santra, Suman Sen
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Abstract

Purpose:

The purpose of the study was to evaluate visual acuity, anatomical outcomes, treatment burden, and safety in patients with diabetic macular edema (DME) initially treated with Aflibercept (AFL) with 3 loading doses and subsequently transitioned to Ranieyes ® -Lupins’ biosimilar ranibizumab (bRBZ) under a pro re nata (PRN) protocol.

Methods:

This multicenter, retrospective observational study included 69 eyes with center-involving DME. All patients received three monthly loading doses of AFL and were subsequently switched to bRBZ for economic reasons, following a PRN regimen. Best-corrected visual acuity (BCVA), central macular thickness (CMT), intraretinal fluid (IRF), subretinal fluid (SRF), and adverse events were evaluated at baseline, at the time of switch, and at 3, 6, 9, and 12 months postswitch. Visual acuity was recorded in logMAR and converted to ETDRS letters for analysis. Paired t -tests and descriptive statistics were used for inferential analyses.

Results:

Mean BCVA improved from 58.4 ETDRS letters at baseline to 70.3 letters at the time of switch ( P < 0.0001) and was 68.4 letters at 12 months ( P < 0.0001), showing sustained functional gain from baseline. Mean CMT was 402.5 ± 53.4 μm at baseline and 283.2 ± 26.1 μm at the time of switch ( P < 0.00001). This anatomical improvement was maintained throughout the 12-month follow-up period after switching to bRBZ. Mean CMT values remained stable at 284.4 ± 17.4 μm at 3 months, 285.3 ± 10.7 μm at 6 months, 286.3 ± 8.6 μm at 9 months, and 284.8 ± 10.1 μm at 12 months, significantly lower than baseline values ( P < 0.00001). Mean postswitch injection frequency was 4.61 ± 0.75 over 12 months. At the end of follow-up, only 20.3% of eyes had persistent IRF and 19% had residual SRF. No serious ocular or systemic adverse events were reported.

Conclusion:

Transitioning from AFL to bRBZ maintained visual gains and anatomical stability in DME patients, with manageable injection burden and good fluid control. These real-world data support the cost-effective use of bRBZ as a viable alternative in long-term DME management, particularly in resource-constrained settings.

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