Chorioretinal vascular diseases are among the leading causes of irreversible vision loss in industrialised countries. These include age-related macular degeneration (AMD), diabetic macular oedema (DME), retinal vein occlusion (RVO), diabetic retinopathy (DR), and myopic choroidal neovascularization (CNV) conditions. Common treatment is with vascular endothelial growth factor (VEGF) inhibitors, which have transformed outcomes but remain costly and resource intensive.

Aflibercept is a recombinant fusion protein that blocks VEGF [2]. The originator product is Regeneron’s Eylea. Alvotech has now developed biosimilar AVT06 (aflibercept) as a pre-filled syringe (PFS).

Pre-filled syringes offer advantages over traditional vials, including reduced preparation time, lower contamination risk, and improved dosing accuracy. In busy ophthalmology clinics, where intravitreal injections are among the most common procedures, these benefits could improve workflow efficiency and patient safety.

This recent study evaluated delivery system usability, making this trial one of the first to assess the practical handling of anti-VEGF biosimilars. It was carried out over seven sites across Latvia and Georgia and was an open-label, single-arm clinical trial of 35 adults with chorioretinal vascular diseases. All injections were carried out successfully by trained retinal specialists and no severe or serious adverse events were reported through Week 52 of the study. Overall, the safety profile aligned with the reference product, Eylea. The results suggest that PFS formats can be safely and efficiently used in routine clinical practice.

The trial was limited by its small sample size and the focus on a single administration to assess the primary endpoint. Larger, comparative studies are needed to confirm long-term safety, efficacy, and usability across diverse patient populations.

AVT06, in both vial and pre-filled syringe presentations, received European Medicines Agency approval in August 2025 as a biosimilar to aflibercept under the brand names Mynzepli (marketed by Advanz Pharma) and Afiveg (by STADA) [3]. It is also under consideration by the US Food and Drug Administration [4].

Overall, this study provides encouraging evidence that AVT06 delivered via pre-filled syringe is safe, well tolerated, and easy to use. If confirmed in larger trials and implemented in practice, biosimilar anti-VEGF therapies with PFS delivery could play a growing role in improving access to retinal treatments and supporting cost-effective ophthalmic care.

Related articles
FDA approves aflibercept biosimilar Eydenzelt and label expansion for adalimumab biosimilar Yuflyma

ANVISA approves biosimilars for denosumab, trastuzumab, and aflibercept

References
1. Cirillo S, Soni R, Rai M, Leutz S, Schurink E, Berti F. Effective and safe handling of pre-filled syringe (PFS) for administration of biosimilar candidate AVT06 (aflibercept) in patients with chorioretinal vascular diseases. Generics and Biosimilars Initiative Journal (GaBI Journal). 2025;14(3).85-92. doi: 10.5639/gabij.2025.1403.016
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of aflibercept [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 16]. Available from: www.gabionline.net/biosimilars/general/biosimilars-of-aflibercept
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval for aflibercept, ustekinumab, and pegfilgrastim biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 16]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-for-aflibercept-ustekinumab-and-pegfilgrastim-biosimilars
4. GaBI Online - Generics and Biosimilars Initiative. Alvotech acquires Xbrane [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2026 Apr 16]. Available from: www.gabionline.net/pharma-news/alvotech-acquires-xbrane

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