Patients With nAMD Maintain Vision on Aflibercept Biosimilar ABP 938

A biosimilar to aflibercept demonstrated comparable efficacy, safety, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD), according to a multinational randomized trial.¹

ABP 938 proved equally effective as aflibercept in the treatment of nAMD | Image credit: eevl - stock.adobe.com

ABP 938, marketed in the US as Pavblu, was developed as a lower-cost alternative to aflibercept (Eylea) to improve access to anti–vascular endothelial growth factor (VEGF) therapy.² Regulatory authorities such as the FDA and the European Medicines Agency require a totality of evidence to establish biosimilarity, including analytical, nonclinical, and clinical studies.¹ Earlier studies had shown structural and functional similarity, and this phase 3 trial was designed to confirm clinical comparability in people with nAMD.

The findings provide additional evidence to support the adoption of biosimilar anti-VEGF agents in ophthalmology. Given the high cost of reference aflibercept and its widespread use in retinal disease, generating $5.97 billion in US sales and $9.5 billion worldwide,³ biosimilars like ABP 938 may play a critical role in expanding patient access while reducing health care spending.

The trial enrolled 579 adults with treatment-naïve nAMD across 102 sites in 16 countries, with 576 included in the analysis. Participants had a mean age of 76 years, 56% were women, and most were White. All patients were randomized to receive either ABP 938 or aflibercept by intravitreal injection, beginning with three monthly doses followed by dosing every 8 weeks. At week 16, patients in the aflibercept arm were rerandomized to either continue aflibercept or transition to ABP 938.

Results showed virtually identical improvements in vision between groups. At week 8, patients treated with ABP 938 gained an average of 6.4 letters on the Early Treatment Diabetic Retinopathy Study scale compared with 6.5 letters for those treated with aflibercept, a difference well within similarity margins defined by regulators. Secondary outcomes, including maintenance of vision, gains of at least 10 or 15 letters, reduction in choroidal neovascularization, and improvement in central subfield thickness, were also comparable across treatment groups.

By week 52, 95.6% of patients who continued on ABP 938, 97.6% of patients who continued on aflibercept, and 95.9% of patients who transitioned from aflibercept to ABP 938 maintained vision. The proportion of patients achieving gains of 15 letters or more ranged from 24% to 30%, depending on the treatment sequence.

Safety findings mirrored the reference product. Adverse events occurred in roughly 39% of ABP 938–treated patients and 37% of aflibercept-treated patients in the first 16 weeks, with most events mild to moderate. The most common ocular adverse event was conjunctival hemorrhage. A total of 6 deaths occurred during the trial, but none were linked to study treatment. The development of antidrug antibodies was infrequent and transient, with similar incidence across groups. A pharmacokinetic substudy also confirmed low systemic exposure for both products.

“[Our] results showed ABP 938 has similar clinical efficacy, safety, and immunogenicity to aflibercept reference product in patients with neovascular age-related macular degeneration,” the study authors wrote, noting that the smaller sample sizes in the re-randomized groups limited some post-transition analyses, but sensitivity testing supported the overall conclusions.

References

1. Friedman S, London N, Hamouz J, et al. Randomized trial of biosimilar ABP 938 compared with reference aflibercept in adults with neovascular age-related macular degeneration. Ophthalmol Retina. Published online August 4, 2025. doi:10.1016/j.oret.2025.07.015

2. Jeremias S. FDA approves Pavblu for retinal conditions. The Center for Biosimilars^®. September 17, 2024. Accessed September 2, 2025. https://www.centerforbiosimilars.com/view/fda-approves-pavblu-for-retinal-conditions

3. Regeneron reports fourth quarter and full year 2024 financial and operating results; initiates quarterly dividend and increases total share repurchase capacity to ~$4.5 billion. News release. Regeneron. February 4, 2025. Accessed September 2, 2025. https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2024-financial