New Data Confirm Efficacy, Safety of switching nAMD Patients to Eylea Biosimilar
A recent 52-week randomized, double-masked clinical study published in Ophthalmology retina demonstrates that patients with neovascular age-related macular degeneration (nAMD) can transition from the reference product Eylea (aflibercept) to its biosimilar, Pavblu (aflibercept-ayyh), without compromising treatment efficacy, safety, or immunogenicity. The findings, released in July 2025, add to a growing body of evidence supporting the use of biosimilars to expand patient access to critical therapies.
the study, involving a large cohort of nAMD patients, assessed outcomes in three groups: those continuing Pavblu, those continuing Eylea, and those switching from Eylea to Pavblu. Researchers found comparable rates of adverse events (AEs) across all groups, with nAMD, hypertension, and COVID-19 being the most commonly observed. Specifically, AEs were reported in 52.7% of those continuing Pavblu, 52.9% of those continuing Eylea, and 57.1% of those who transitioned to the biosimilar. nAMD was the most frequently reported AE, occurring in 5.9%, 8.1%,and 7.5% of patients in the respective groups.The study authors concluded that “this…study demonstrated that the efficacy, safety, and immunogenicity were not altered by a transition from [the reference] to [its biosimilar].” these results, combined with prior analytical and functional similarity data, contribute to the “totality of evidence” supporting the biosimilarity of Pavblu and Eylea. Pavblu received FDA approval in August 2024, marking the fifth Eylea biosimilar to enter the market.
The research was led by Friedman S,London N,Hamouz J,et al., and is available under DOI: 10.1016/J.Ot.2025.07.015. Further facts about the study (NCT04270747) can be found on ClinicalTrials.gov.
