Biosimilar Ranibizumab Could be More Cost-Effective Than Aflibercept for nAMD

Switching from intravitreal aflibercept (Eylea; Regeneron Pharmaceuticals) to an intravitreal biosimilar of ranibizumab (Lucentis; Genentech) showed efficacy in maintaining visual acuity and macular anatomy for patients who had neovascular age-related macular degeneration (nAMD), according to results of a study published in Clinical Ophthalmology.¹

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nAMD is a serious type of late AMD, occurring when vascular endothelial growth factor (VEGF) causes abnormal blood vessels in the wrong place on the back of the eye, affecting the vision. Anti-VEGF injections, such as aflibercept or ranibizumab, or photodynamic therapy can delay or stop vision loss due to nAMD, according to the National Eye Institute.²

Anti-VEGF medications can help stop bleeding and leaking of blood vessels in the back of the eye and are injected into the eye with a small needle. Typically, they injections work for a short period of time, so patients will need many injections. According to authors of a study published in JAMA Ophthalmology, an estimated 18.34 million individuals in the US aged 40 years and older were living with early-stage AMD and 1.49 million had late-stage AMD in 2019.³

In the current study, investigators aimed to analyze the response to switching aflibercept to biosimilar ranibizumab. The study was conducted in multiple hospitals in eastern India, including patients who are aged 50 years and older, had previously untreated subfoveal choroidal neovascularization lesion secondary to nAMD in the study eye, leakage from the subfoveal choroidal neovascularization detected by fluorescein angiography, and a baseline visual acuity of 20/40 or worse, according to the study authors. The investigators reviewed medical record of patients who were treated with intravitreal injection aflibercept 2 mg in 0.05 mL between July 2020 and June 2021.¹

The main outcome was change in best corrected visual acuity before and after switching, and secondary outcomes included changes in central macular thickness from baseline and follow-up of up to 12 months, according to the study authors.¹

There were 29 eyes analyzed among 12 males and 17 females. The population had a mean age of 72 years, a total number of 5 aflibercept injection in each eye, and a mean number of 6.79 biosimilar ranibizumab injections. The baseline visual acuity was normal, according to the investigators, and the mean visual acuity improved from 55 at baseline to 70 after switching. At additional follow-ups, the scores remained significantly better than at baseline, and a linear regression analysis showed a strong positive correlation between baseline and the switch.¹

For central macular thickness, investigators found that the baseline did not follow normal distribution, but post-switching, there was a significant reduction from 400 μm to 290 μm. The decrease was maintained over 12 months with a mean of 280 at the final follow up, according to the investigators. Additionally, the baseline prevalence of sub-retinal fluid was 96.55%, decreasing to 17.24% at the switch, then increasing again to 44.83% at the 12-month mark. The pattern with intraretinal fluid was similar at 55.17%, 6.9%, and 34.48%, respectively, according to the study authors.¹

Furthermore, there was a strong positive correlation between the patient age and the total number of injections, with older individuals receiving more injections. Investigators believe that this could suggest age as a factor in treatment frequency.¹

References

1. Chakraborty D, Boral S, Sinha TK, et al. Transitioning from Aflibercept to Biosimilar Ranibizumab in Neovascular AMD (The TRANSFORM Trial): A Multicenter Observational Study. Clin Ophthalmol. 2024;18:1819-1828. Published 2024 Jun 24. doi:10.2147/OPTH.S459085

2. National Eye Institute. Treatments for Wet AMD (Advanced Neovascular AMD). June 22, 2021. Accessed July 12, 2024. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration/treatments-wet-amd-advanced-neovascular-amd

3. Rein DB, Wittenborn JS, Burke-Conte Z, et al. Prevalence of Age-Related Macular Degeneration in the US in 2019. JAMA Ophthalmol. 2022;140(12):1202–1208. doi:10.1001/jamaophthalmol.2022.4401