Efficacy, Safety of Aflibercept 8 mg Proven for Treatment of AMD

A recent systematic literature review has indicated the efficacy and safety of utilizing aflibercept 8 mg to treat neovascular age-related macular degeneration (nAMD).1

Aflibercept is one of several drugs created to inhibit vascular endothelial growth factor (VEGF); aflibercept 2 mg has been heavily studied and is widely used as a standard of care for nAMD. While aflibercept 8 mg has shown promising visual gains and a safety profile comparable to 2 mg, it remains largely under-researched in terms of comparative efficacy.2

Aflibercept 8 mg was approved for the treatment of AMD, DME, and diabetic retinopathy (DR) by the US Food and Drug Administration in August 2023. The treatment is the first approved for both wet AMD and DME for immediate dosing at 8- and up to 16-week intervals following 3 initial monthly doses. The approval was based on results from the PULSAR and PHOTON trials.3

“Aflibercept 8 mg demonstrates a comparable efficacy and safety to currently available anti-VEGF treatments for nAMD, with the potential added benefit of requiring fewer injections,” wrote Paolo Lanzetta, MD, department of medicine-ophthalmology, University of Udine, and colleagues. “These results suggest that aflibercept 8 mg could be a favourable treatment option for nAMD, achieving sustained disease control while alleviating the burden of injections on patients, caregivers, and healthcare providers.”1

Investigators searched the MEDLINE, Embase, the Cochrane Library databases, and the ClinicalTrials.gov registry to identify studies comparing aflibercept 8 mg with other prominent anti-VEGF treatments. A total of 7742 studies were initially gathered; after excluding duplicates and screening titles and abstracts, investigators confirmed 21 eligible studies. All studies included ≥1 anti-VEGF agent, including aflibercept (2 and 8 mg), ranibizumab, brolucizumab, faricimab, and bevacizumab.1

Efficacy outcomes of interest included change in best-corrected visual acuity (BCVA), central retinal thickness (CRT), and central subfield thickness (CST), as well as the percentage of patients experiencing gains or losses of 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Treatment burden was defined as mean number of injections given during the first year of treatment.1

Lanzetta and colleagues then conducted a network meta-analysis of the collected publications, which compared aflibercept 8 mg to the other anti-VEGF treatments over a 1-year period. Notably, no significant difference was identified between aflibercept 8 mg and faricimab, ranibizumab, and aflibercept 2 mg for the outcomes of BCVA change from baseline and the proportion of patients gaining or losing ≥15 EDTRS letters.

The team observed a greater decrease from baseline in CRT and CST with aflibercept 8 mg versus ranibizumab. However, there was no significant difference when compared against aflibercept 2 mg and faricimab. Lanzetta and colleagues indicated no significant differences in the proportion of patients with adverse effects, ocular or non-ocular, between aflibercept 8 mg and any comparators.1

Notably, aflibercept 8 mg reported the lowest number of intravitreal injections, with 5.1 during the first year of treatment. By comparison, faricimab reported a range of 6.2-6.7 injections over the first year, which was comparable to that of aflibercept 2 mg and ranibizumab, while brolucizumab reported 6.31 injections and bevacizumab reported a maximum of 11.9. Aflibercept 8 mg was also substantially better than bevacizumab at drying the retina.1

These data indicate that aflibercept 8 mg exhibits a comparable safety profile to all other anti-VEGF treatments and noninferiority to other common treatments. Lanzetta and colleagues noted that, due to the lowest treatment burden, aflibercept 8 mg could be an optimal choice for the treatment of nAMD.

“These results were achieved with fewer injections, which suggests that aflibercept 8 mg with extended-dosing intervals has the potential to improve the management of patients with nAMD,” Lanzetta and colleagues wrote.1

References

1. Wojciechowski P, Wdowiak M, Panek M, et al. Efficacy, safety, and injection frequency with novel aflibercept 8 mg in neovascular age-related macular degeneration: A comparison with existing Anti-VEGF regimens using a Bayesian network meta-analysis. Ophthalmology and Therapy. 2025;14(4):733-753. doi:10.1007/s40123-025-01098-y

2. Lanzetta P, Korobelnik JF, Heier JS, et al. Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial. Lancet. 2024;403(10432):1141-1152. doi:10.1016/S0140-6736(24)00063-1

3. Cambell P. Aflibercept 8 mg (Eylea HD) Approved by FDA for Wet AMD, DME, and Diabetic Retinopathy. HCP Live. August 19, 2023. Accessed April 8, 2025. https://www.hcplive.com/view/aflibercept-8mg-eylea-hd-approved-by-fda-for-wamd-dme-and-diabetic-retinopathy