News|Articles|March 11, 2026

Aflibercept Biosimilar Showed Improvements in RVO-Associated Macular Edema

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Key Takeaways

Treatment-naïve BRVO eyes showed logMAR BCVA improvement (0.64 to 0.41) alongside CRT reduction (527 µm to 285 µm) over short-term follow-up with SB15.
Central RVO eyes improved from logMAR 1.29 to 0.78, with CRT decreasing from 897 µm to 439 µm, but conclusions are constrained by n=5.
Most eyes achieved initial complete fluid resolution after one injection, yet recurrence was common (BRVO 11/19; CRVO 2/4), supporting ongoing OCT-guided retreatment.
Study design limitations included no comparator arm, variable visit intervals, short follow-up, and omission of loading injections, underscoring the need for larger controlled CRVO-inclusive datasets.

Short-term anatomical and visual improvements were found when patients used SB15 to treat their macular edema caused by retinal vein occlusion (RVO).

The aflibercept biosimilar, SB15, led to visual and anatomical improvements in patients with macular edema associated with retinal vein occlusion (RVO) through a short-term follow-up.¹ The results, published in BMC Ophthalmology, indicate that the biosimilar could be valuable for treating the condition.

Aflibercept is an intravitreal anti–vascular endothelial growth factor (anti-VEGF) injection that can be used for the treatment of macular edema associated with RVO. The biosimilar SB15 is a biological agent that has been able to demonstrate equivalent equivalency in age-related macular degeneration and has been approved by the FDA.² Although SB15 has been approved for use in macular edema secondary to RVO due to aflibercept working in this indication, SB15 has never been studied for equivalence by itself. This study aimed to assess the short-term outcomes of patients using SB15 for the treatment of macular edema secondary to RVO.

Patients included in this study were treatment-naive and had been diagnosed with macular edema secondary to either central RVO (CRVO) or branch RVO (BRVO). Patients who received injections of SB15 between May 2024 and December 2024 were included. Patients with a history of vitreoretinal surgery, who had the presence of other macular diseases, and who had a follow-up period of less than 4 months after their injection were excluded from the study.

Every patient was followed up at 4- to 10-week intervals after their injection, where best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were both measured consistently. Patients received more injections if retinal fluid persisted after the first injection but otherwise did not receive an injection after the first.

There were 29 eyes from 29 patients included in the study. The mean (SD) age of the patients was 65.4 (11.5) years. BRVO was diagnosed in 24 patients, whereas CRVO was diagnosed in 5. The mean time from diagnosis to first SB15 injection was 10.7 (15.7) weeks, and the mean interval between the first injection and the first post-injection visit was 5.0 (2.1) weeks. Follow-up was 7.7 (2.3) months.

The mean logMAR BCVA was 0.64 (0.36) at baseline for patients with BRVO, which progressed to 0.45 (0.26) at the first visit and 0.41 (0.32) at the last follow-up. Mean CRT decreased from 527.1 (181.9) µm at baseline to 285.1 (99.5) µm at the final follow-up. A total of 19 eyes had complete resolution of retinal fluid after 1 injection, although 11 experienced fluid recurrence after follow-up.

The mean logMAR BCVA was 1.29 (0.26) at baseline and 0.78 (0.61) at the final follow-up in patients with CRVO. The mean CRT was 897.0 (344.5) µm at baseline and decreased to 439.4 (268.9) µm at the final follow-up. There were 4 eyes that had complete resolution of retinal fluid after 1 injection, although 2 experienced fluid recurrence.

There were some limitations to this study. The study was exploratory due to the limited sample size and lack of a control group. Intervals between visits and the duration of follow-up varied between different patients. Long-term efficacy was not evaluated in the study. There were only 5 patients with CRVO included. There were no loading injections administered to the patients.

The researchers concluded that SB15 led to significant improvements in BCVA and anatomical outcomes in the BRVO group in particular after a mean of 1.7 injections. “However, given the limitations of this study, further studies, particularly those including a larger number of patients with CRVO, are warranted to confirm the study results,” the authors wrote.

References

Cho J, Park SM, Kim CG, Kim JH. Short-term outcomes of aflibercept biosimilar SB15 in macular edema secondary to retinal vein occlusion. BMC Ophthalmol. Published online March 7, 2026. doi:10.1186/s12886-026-04683-2
Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars^®. May 20, 2024. Accessed March 9, 2026. https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars