Abstract
PURPOSE: To evaluate the short-term outcomes of SB15, an aflibercept biosimilar approved by the U.S. Food and Drug Administration, for the treatment of macular edema secondary to retinal vein occlusion (RVO). METHODS: This retrospective study included 29 treatment-naïve patients diagnosed with macular edema secondary to branch retinal vein occlusion (BRVO)(n = 24) or central retinal vein occlusion (CRVO) (n = 5). All patients received intravitreal SB15 injection as the initial treatment and were followed up for a mean of 7.1 months. Additional injections were administered as necessary. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were evaluated at baseline, after the first injection, and at the final follow-up in both the BRVO and CRVO groups. RESULTS: In the BRVO group, the mean logMAR BCVA improved from 0.64 ± 0.36 at baseline to 0.45 ± 0.26 after the first injection and to 0.41 ± 0.32 at the final follow-up (P < 0.001). The mean CRT decreased from 527.1 ± 181.9 μm to 261.3 ± 95.8 μm and 285.1 ± 99.5 μm, respectively (P < 0.001). In the CRVO group, the mean logMAR BCVA improved from 1.29 ± 0.26 at baseline to 0.90 ± 0.54 after the first injection and to 0.78 ± 0.61 at the final follow-up (P = 0.022). The mean CRT decreased from 897.0 ± 344.5 μm to 213.2 ± 24.4 μm and 439.4 ± 268.9 μm, respectively (P = 0.015). CONCLUSIONS: SB15 demonstrated short-term anatomical and visual improvements in patients with RVO-associated macular edema, suggesting that it may have some therapeutic effect in this condition. CLINICAL TRIAL NUMBER: Not applicable.