A recent study published in Clinical Ophthalmology reveals that patients with neovascular age-related macular degeneration (nAMD) can successfully switch from aflibercept to a ranibizumab biosimilar while maintaining visual acuity and macular anatomy. The multicenter, retrospective study, conducted in eastern India, suggests that biosimilar anti-VEGF agents could offer a more accessible and affordable treatment option for nAMD patients.
The study included 29 patients aged 50 or older with baseline visual acuity of 20/40 or worse. Researchers monitored changes in best corrected visual acuity (BCVA) and central macular thickness (CMT) over a 12-month period following the switch. The mean visual acuity improved from 55 ± 10.2 at baseline to 70 ± 8.5 at the time of switching. At the 12-month follow-up, the mean visual acuity was 62.3 ± 8.9, indicating an overall improvement of approximately 7.6 Early Treatment Diabetic Retinopathy Study letters from baseline.
Anatomical Improvements and Fluid Management
The analysis also showed a significant decrease in average CMT from 400 ± 50 mm at baseline to 290 ± 45 mm at the switch. This reduction was sustained throughout the follow-up, with a final CMT of 280 ± 40 mm (P < .01). The proportion of patients with subretinal fluid (SRF) decreased significantly immediately after switching to the biosimilar ranibizumab, but a moderate increase in SRF was observed at the 12-month follow-up, reaching 44.83%.
Cost-Effectiveness and Accessibility
The advent of anti-VEGF therapy has revolutionized AMD treatment, but the high costs of drugs like aflibercept pose a significant barrier to access. Biosimilars offer a promising solution by potentially lowering drug costs and expanding treatment accessibility. As the study authors noted, "Biosimilar anti-VEGF agents offer a promising solution to this problem, potentially making effective AMD treatment accessible to more patients and easing the financial burden on the health care system."
Study Limitations and Future Directions
Despite the positive findings, the study had several limitations, including its retrospective design, small sample size, brief follow-up period, and lack of a control group. The authors also acknowledged that adverse events (AEs) might have been underreported due to the reliance on medical chart analysis. No serious AEs were reported during either the initial aflibercept treatment or the subsequent biosimilar ranibizumab treatment.
Implications for Clinical Practice
These findings suggest that switching from aflibercept to a ranibizumab biosimilar is a viable option for nAMD patients, particularly in settings where cost is a major consideration. While further research with larger, controlled trials is needed, this study provides valuable real-world evidence supporting the use of biosimilars in ophthalmology.
