Purpose <p>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).</p> Methods <p>This retrospective study included 29 treatment-naïve patients diagnosed with macular edema secondary to branch retinal vein occlusion (BRVO)(<i>n</i> = 24) or central retinal vein occlusion (CRVO) (<i>n</i> = 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.</p> Results <p>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 (<i>P</i> &lt; 0.001). The mean CRT decreased from 527.1 ± 181.9&#xa0;μm to 261.3 ± 95.8&#xa0;μm and 285.1 ± 99.5&#xa0;μm, respectively (<i>P</i> &lt; 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).</p> Conclusions <p>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.</p> Clinical trial number <p>Not applicable.</p>

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Short-term outcomes of aflibercept biosimilar SB15 in macular edema secondary to retinal vein occlusion

  • Jaejin Cho,
  • Sang Min Park,
  • Chul Gu Kim,
  • Jae Hui Kim

摘要

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.