Biosimilar QL1207 Demonstrates Equivalent Efficacy and Safety in DME

Efforts to expand access to vision-saving therapies for people with diabetic eye disease increasingly depend on the availability of lower-cost biologic alternatives, and new comparative data add clarity to how one aflibercept biosimilar performs in routine clinical practice. A recently published retrospective analysis evaluated whether the aflibercept biosimilar QL1207 offered similar outcomes to reference aflibercept for individuals with diabetic macular edema (DME), a leading cause of vision impairment among people with diabetes.

The study was conducted to address a longstanding gap in real-world data. Although QL1207 was approved by China’s National Medical Products Administration in late 2023 based on structural and functional similarity to reference aflibercept, published comparative clinical information in DME populations remained limited.

Given the high cost of originator anti-VEGF therapy and the chronic, injection-intensive nature of DME management, the investigators sought to determine whether the biosimilar performed comparably in anatomical and functional outcomes, macular perfusion metrics, injection burden, and safety.

The analysis included anonymized clinical data from 80 adults (80 eyes) with nonproliferative diabetic retinopathy and DME who were seen at a single ophthalmology department between June 2023 and April 2024. Participants were treatment-naïve and met diagnostic criteria outlined in the American Academy of Ophthalmology’s 2019 clinical guidelines. Individuals were excluded if they had other retinal diseases, a history of ocular procedures, proliferative disease, significant media opacity, or a hemoglobin A1c greater than 7%.

Demographic characteristics were balanced across treatment groups. The reference aflibercept group included 40 people (20 men and 20 women) with a mean age of 48.6 years. The QL1207 group included 40 people (19 men and 21 women) with a mean age of 46.7 years. Baseline HbA1c levels were similar, and no clinically meaningful differences emerged during the 12-month follow-up period.

All participants received 3 monthly loading doses followed by a pro re nata retreatment approach. Retreatment criteria included central retinal thickness (CRT) greater than 280 µm or a decrease of 5 or more Early Treatment Diabetic Retinopathy Study letters. Best-corrected visual acuity (BCVA), optical coherence tomography measures, and optical coherence tomography angiography parameters—including foveal avascular zone (FAZ) area and superficial and deep vascular density (SVD and DVD)—were collected at baseline and during follow-up. The investigators also recorded injection frequency and adverse events.

The study found no statistically significant differences between groups in BCVA or CRT at baseline or at 1, 3, 6, or 12 months. Both groups demonstrated significant improvement in BCVA relative to their own pretreatment values, as well as substantial reductions in CRT (P < .05 for all within-group comparisons). At 12 months, mean CRT decreased from 447.1 µm to 280.4 µm in the reference group and from 441.0 µm to 290.3 µm in the QL1207 group. Injection burden was also similar, with mean injection counts of 3.58 in the reference group and 3.40 in the biosimilar group (P = .272).

Macular microvascular outcomes also aligned closely across groups. FAZ area decreased significantly within each group, while both SVD and DVD increased, indicating improved or stabilized macular perfusion. None of these parameters differed significantly between groups at baseline or month 12.

Safety outcomes were consistent with the known safety profile of intravitreal anti-VEGF therapy. Mild events—including transient intraocular pressure elevations, corneal epithelial damage, and subconjunctival hemorrhage—occurred infrequently and at similar rates in both groups. No individuals experienced endophthalmitis, glaucoma, vitreous hemorrhage, cataract progression, or systemic cardiovascular or cerebrovascular events during the follow-up period.

The authors noted several limitations, including the retrospective design, relatively small sample size, nonrandomized treatment assignment, and 12-month follow-up period. In addition, while statistically significant changes in OCT angiography parameters were documented, their clinical significance remains uncertain. Longer, prospective, randomized studies will be needed to validate long-term comparability between QL1207 and reference aflibercept in DME.

Even with these limitations, the findings contribute to growing real-world evidence showing that aflibercept biosimilars may offer an effective and potentially more affordable option for individuals living with DME. As biosimilar adoption grows globally, studies like this may help inform formulary decisions and support broader access to sight-preserving therapy.

Reference

Zhai G, Liu N, Wang S, Zhang X. Comparative efficacy of intravitreal aflibercept biosimilar QL1207 versus reference aflibercept in the treatment of diabetic macular edema. Front Med (Lausanne). 2025:12:1662735. doi:10.3389/fmed.2025.1662735