Patients With nAMD Successfully Switch From Aflibercept to Ranibizumab

Patients with neovascular age-related macular degeneration (nAMD) demonstrated maintained visual acuity and macular anatomy when switching from intravitreal aflibercept to biosimilar ranibizumab, but some challenges in fluid management persisted, according to a study published in Clinical Ophthalmology.¹

Both AMD and nAMD are common among the elderly population, and cases have increased over the years. Treatment for AMD was revolutionized with the development of anti-vascular endothelial growth factor (VEGF) therapy, which inhibits the growth of abnormal blood vessels in the retina while reducing fluid leakage. Anti-VEGF drugs include bevacizumab, ranibizumab, aflibercept, brolucizumab, and faricimab, which typically come athigh costs, creating access barriers for most patients.

“The advent of anti-VEGF therapy has been a game-changer in the management of this condition, particularly wet AMD. However, the high costs of these drugs remain a challenge,” the authors wrote. "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. Therefore, they have the potential to play a crucial role in the future landscape of AMD treatment.”

Biosimilar anti-VEGF agents were created with the intention of lowering drug costs while offering lifesaving drugs at an affordable, accessible rate. Some patent expirations have led to reduced biosimilar drug costs while further facilitating the approval and adoption of various other biosimilar treatments.² In places like Singapore, Denmark, and Sweden, biosimilar promotion has led to quicker adoption through analysis of the cost benefits.

Researchers aim for similar cost savings to be emulated globally through biosimilar manufacturing. Biosimilar development has prompted market growth among major drug companies, offering potential cost savings and profit.³

The new study aimed to determine how eyes with nAMD respond to the switch from aflibercept to the biosimilar ranibizumab, as data in this area are lacking, according to the study authors.¹

The multicenter, retrospective, observational study was led in a group of eye hospitals in eastern India with participants who were 50 years or older with baseline visual acuity of 20/40 or worse. The primary outcome measure was the change in best corrected visual acuity (BCVA) before and after switching. Changes in central macular thickness (CMT) from baseline to follow-up at 12 months were measured as secondary outcomes.

A total of 29 patients were included in the study, with a median age of 72.55 years. The study population had slightly more female (58.6%) than male (41.4%) participants. The mean visual acuity improved from baseline (55 ± 10.2) to the switch (70 ± 8.5). By the 12-month final follow-up, the mean visual acuity was 62.3 ±8.9.,There was an improvement of around 7.6 Early Treatment Diabetic Retinopathy Study letters in visual acuity from baseline.

The analysis revealed a positive association between higher initial visual acuity and subsequent visual acuity outcomes. Although noninferiority to the switch was not demonstrated at the final follow-up, there was a significant improvement in overall visual acuity.

There was a significant decrease in average CMT from baseline (400 ± 50 mm) to the switch (290 ± 45 mm). This reduction persisted throughout the 12-month follow-up period, with a final CMT of 280 ± 40 mm. The consistent changes in CMT over time were statistically significant(P< .01).

The proportion of patients with subretinal fluid (SRF) decreased significantly to 17.24% from the time of switching to biosimilar ranibizumab. Follow-ups that occurred after switching to the biosimilar ranibizumab showed a moderate increase in the presence of SRF, reaching 44.83% after 12 months. Similarly, 55.17% of patients had intraretinal fluid at baseline but decreased from aflibercept to 6.9% at the time of switching, indicating an effective response to the original treatment.

There was a strong, positive correlation between patient age and the total number of injections received, indicating that older patients tended to receive more injections.

No serious adverse events (AEs) were found during the initial phase of aflibercept treatment or subsequent treatment with the biosimilar ranibizumab. However, it is important to note that it is difficult to make definite assumptions on AEs due to the small number of participants.

Study limitations include the retrospective design, small sample size, brief follow-up period, lack of control group, and the use of the PRN regimen. Additionally, the study was not powered for safety analysis, and AEs could have been underreported because the study was based on medical chart analysis, the authors noted.

Regardless of study limitations, the research provides insight into the potential of biosimilar anti-VEGF therapy to offer more accessible and affordable treatment options, especially among patients with financial or insurance restrictions.

“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,” the study authors concluded.

References

1. Chakraborty D, Boral S, Sinha TK, et al. Transitioning from aflibercept to biosimilar ranibizumab in neovascular AMD (The TRANSFORM Trial): amulticenter observational study. Clin Ophthalmol. 2024;18:1819-1828. doi:10.2147/OPTH.S459085
2. Jeremias S. Singapore experience shows benefit of value-driven strategies in generating biosimilar savings.The Center for Biosimilars®. July 30, 2024. Accessed September 5, 2024. https://www.centerforbiosimilars.com/view/singapore-experience-shows-benefits-of-value-driven-strategies-in-generating-biosimilar-savings
3. Sharma A, Reddy P, Kuppermann BD, Bandello F, Lowenstein A. Biosimilars in ophthalmology: "Is there a big change on the horizon?". Clin Ophthalmol. 2018;12:2137-2143. doi:10.2147/OPTH.S180393