Aflibercept biosimilar use and real-world outcomes in various retinal diseases: the AURA Korea study

This multicenter, retrospective real-world study evaluated the efficacy and safety of aflibercept 2 mg biosimilar SB15 (Afilivu®) across multiple retinal diseases. A total of 1083 eyes from 984 patients received 2762 injections between March 2023 and February 2025 at three South Korean tertiary centers, comprising 188 treatment-naïve (17.4%) and 895 switching eyes (82.6%). Diagnoses included neovascular age-related macular degeneration (nAMD, n = 611), retinal vein occlusion (RVO, n = 182), diabetic macular edema (DME, n = 173), and other conditions (n = 117). Over a mean follow-up of 5.17 ± 2.76 months with 2.55 ± 1.09 injections, central foveal thickness decreased significantly by - 47.5 µm (95% CI - 55.2 to - 39.8; P < 0.001), while best-corrected visual acuity remained stable (mean change - 0.003 LogMAR; P = 0.572). Treatment-naïve eyes demonstrated greater anatomical improvement than switching eyes (- 93.9 vs. - 37.9 µm; P < 0.001). Retinal fluid resolved significantly across diagnostic groups: in nAMD, subretinal fluid decreased from 51.2 to 29.6% (P < 0.001); in RVO, intraretinal fluid reduced from 92.9 to 76.4% (P < 0.001); and in DME, intraretinal fluid decreased from 90.8 to 84.4% (P = 0.002). One case (0.09%) of rhegmatogenous retinal detachment occurred; no intraocular inflammation or other serious adverse events were observed. These findings support the real-world effectiveness and safety of SB15 (Afilivu®) in both treatment-naïve and switching populations across diverse retinal diseases.