Real-World Utilization and Initial Experience with Aflibercept-ayyh (PAVBLU^®) for Retinal Disorders in United States...

Anti-vascular endothelial growth factor (anti-VEGF) therapies are standards of care for vision-threatening retinal diseases. This retrospective observational study describes demographics, utilization, best recorded visual acuity (BRVA), and safety among eyes with neovascular age-related macular degeneration (nAMD), diabetic retinopathy (DR), diabetic macular edema (DME), or retinal vein occlusion (RVO) treated with the biosimilar aflibercept-ayyh (PAVBLU^®) in routine clinical practice.

Electronic medical records from the Retina Consultants of America database of patients receiving aflibercept-ayyh (12/1/2024-10/31/2025) were analyzed, focusing on eyes with ≥ 84 days of follow-up. The index date was defined as the first documented aflibercept-ayyh injection. Post-index data were used to evaluate treatment patterns, changes in BRVA, and adverse events of special interest (AESIs). Within-eye changes in BRVA were assessed using the Wilcoxon signed rank test and summarized as mean change in logarithm of the minimum angle of resolution (ΔlogMAR).

A total of 1000 consecutive eyes from 989 patients (55% female, 43% male, 2% unknown) received 3730 injections of aflibercept-ayyh; 91% switched from prior anti-VEGF therapy and 9% were anti-VEGF treatment-naïve. Disease distribution was 58% nAMD, 19% RVO, 16% DME, and 7% DR. Among switchers, median (IQR) number of prior injections was 21 (8, 46). Median (IQR) follow-up was 6.0 months (4.6, 7.1). Median (IQR) number of aflibercept-ayyh injections per eye was 4 (3, 5). Among eyes with ≥ 84 days of follow-up (n = 889), mean BRVA logMAR remained stable for switchers (0.4 to 0.4; P = 0.96) and improved from baseline in anti-VEGF-naïve eyes (0.5 to 0.4; P < 0.01). Confirmed AESIs included iritis (n = 2; 0.05% of injections), with no events of vitreous cells, endophthalmitis, retinal detachment, retinal vasculitis, or vitreous hemorrhage.

In this descriptive real-world analysis, aflibercept-ayyh was associated with stable visual acuity in previously treated eyes and vision improvement in treatment-naïve eyes, with no new or unexpected safety findings, consistent with expectations for aflibercept and the established body of evidence supporting biosimilarity between aflibercept-ayyh and reference aflibercept, EYLEA^®).