ORIGINAL RESEARCH article
Front. Med.
Sec. Ophthalmology
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1662735
Comparative efficacy of intravitreal aflibercept biosimilar QL1207 versus reference aflibercept in the treatment of diabetic macular edema
Provisionally accepted
- Zibo Central Hospital, Shandong, China
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Purpose: This study aims to conduct a comparative evaluation of the clinical efficacy between intravitreal injections of aflibercept biosimilar QL1207 and reference aflibercept in the treatment of diabetic macular edema (DME). Methods: This retrospective study analyzed the clinical data of 80 patients (80 eyes) with DME who underwent initial treatment at our hospital's Department of Ophthalmology between June 2023 and April 2024. Forty patients (40 eyes) received intravitreal injections of the reference aflibercept (aflibercept group). Forty patients (40 eyes) were treated with intravitreal injections of the aflibercept biosimilar QL1207 (QL1207 group). All patients received a 3 + PRN (pro re nata) treatment regimen and completed a minimum follow-up period of 12 months. Best-corrected visual acuity, optical coherence tomography (OCT), and optical coherence tomography angiography (OCTA) were assessed before and after treatment. BCVA and central retinal thickness (CRT) were compared between the two groups at baseline and at 1, 3, 6, and 12 months post-treatment. Additionally, the foveal avascular zone (FAZ) area, macular vessel density, the number of intravitreal injections required, and the incidence of adverse reactions were evaluated before and 12 months after treatment. Results: The intergroup comparison of BCVA and CRT before and after treatment showed no statistically significant differences (P > 0.05). After treatment, both groups showed significant improvement in BCVA and reduction in CRT compared to pretreatment values (P < 0.05) . No statistically significant intergroup differences were observed in the FAZ area, superficial vascular density (SVD) and deep vascular density (DVD) at baseline and 12 months after treatment (P> 0.05 for all comparisons). Following treatment, both groups demonstrated a significant decrease in FAZ area alongside a concurrent increase in SVD and DVD compared to pretreatment values (P < 0.05 for all parameters) . During the follow-up period, no statistically significant difference was observed in the number of intravitreal injections administered between the reference aflibercept group (3.58 ± 0.71) and the QL1207 group (3.40 ± 0.63) (P = 0.272). Conclusions: Both the reference aflibercept and its biosimilar QL1207 demonstrate comparable efficacy in the treatment of DME, effectively reducing macular edema, improving BCVA, and enhancing macular perfusion status.
Keywords: aflibercept biosimilar, diabetic macular edema, Foveal avascular zone, Vascular density, Best-corrected visual acuity
Received: 09 Jul 2025; Accepted: 06 Oct 2025.
Copyright: © 2025 Zhai, Liu, Wang and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Xia Zhang, 835076777@qq.com
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