QL1207, Aflibercept Biosimilar, Has Comparable Efficacy to Reference Product Treating Diabetic Macular Edema

Data published in Frontiers Medicine show that QL1207 (Qilu Pharmaceutical Co, Ltd), a biosimilar to reference aflibercept (Eylea; Regeneron), has comparable efficacy to its reference product when treating diabetic macular edema (DME). Specifically, the biosimilar improved best-corrected visual acuity (BCVA) and enhanced macular perfusion status.¹

Reference aflibercept injections are used in the treatment of eye-related conditions, such as neovascular (wet) age-related macular degeneration, DME, and diabetic retinopathy, as well as retinopathy of prematurity in premature infants. Aflibercept changes the amount of blood that gets to the retina and is administered via intraocular injections after retinal vein occlusion.²

In the October 2025 study, QL1207, which is the first aflibercept biosimilar to be developed in China³, had its clinical efficacy comparatively evaluated to intravitreally administered reference aflibercept in the treatment of DME. The retrospective study analyzed the clinical data of 80 eyes from 80 patients (1 eye per patient) with DME who underwent initial treatment at the Department of Ophthalmology in the authors’ hospital between June 2023 and April 2024. Half of the enrolled patients (40 eyes) received intravitreal injections of the reference aflibercept (aflibercept group), and the other half were treated with intravitreal injections of the biosimilar QL1207 (QL1207 group). All patients received a 3 + pro re nata (PRN) treatment regimen—in which treatment was administered only when signs of disease activity were present or reappeared—and completed a minimum follow-up period of 12 months.¹

BCVA, optical coherence tomography (OCT), and optical coherence tomography angiography (OCTA) were assessed prior to and following treatment. BCVA and central retinal thickness (CRT) were compared between the 2 treatment groups at baseline and at 1, 3, 6, and 12 months following treatment. Additionally, the foveal avascular zone (FAZ) area, macular vessel density, the number of intravitreal injections required, and the incidence of adverse events (AEs) were evaluated before and 12 months after treatment.¹

The intergroup comparison of BCVA and CRT before and after treatment was observed to have no statistically significant differences (p > .05). Following treatment, both groups showed significant improvement in BCVA and reduction in CRT compared with pretreatment values (p < .05). In addition, 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 > .05 for all comparisons). Following treatment, both groups were observed to have a significant decrease in FAZ area alongside a concurrent increase in SVD and DVD compared to pretreatment values (p < .05 for all parameters).¹

During the follow-up period, there was no statistically significant difference 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 = .272). Throughout the follow-up period, no patients developed severe ocular complications, including endophthalmitis, glaucoma, cataract progression, or vitreous hemorrhage. Also of note, no cardiovascular or cerebrovascular events were reported during the treatment period.¹

Overall, the findings show that both 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.¹ These data are significant for patients with DME who may experience difficulty receiving or affording treatment, and the biosimilar may be a more affordable option patients can adhere to.

REFERENCES

1. 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. 2025 Oct 21:12:1662735. doi:10.3389/fmed.2025.1662735.

2. Mayo Clinic. Aflibercept (intraocular route). Accessed December 11, 2025. http://mayoclinic.org/drugs-supplements/aflibercept-intraocular-route/description/drg-20075363

3. Pearce IP. Qilu’s Aflibercept Biosimilar Equivalent to Regeneron’s Eylea® for nAMD. News release. February 13, 2024. Accessed December 11, 2025. https://www.pearceip.law/2024/02/13/qilus-aflibercept-biosimilar-equivalent-to-regenerons-eylea-for-namd/