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Sustained Anti-Vascular Endothelial Growth Factor Activity of Aflibercept (Eylea) After Storage in Polycarbonate Syringes Used for Intravitreal Injection: A Pathway to Safety and Efficiency. J Ocul Pharmacol Ther 2019 06;35(5):278-282

Date

03/28/2019

Pubmed ID

30916605

Pubmed Central ID

PMC6588124

DOI

10.1089/jop.2018.0085

Scopus ID

2-s2.0-85067020226   2 Citations

Abstract

Purpose: Aflibercept (Eylea™, Regeneron) is supplied in single-use glass vials along with 1 cc polycarbonate syringes. We sought to determine if storage of aflibercept for sustained periods within these syringes would result in loss of antivascular endothelial growth factor (anti-VEGF) activity. Methods: Aflibercept samples were drawn from commercially available glass vials into manufacturer-supplied 1-mL syringes and stored at 4°C. Anti-VEGF activity was assessed using enzyme-linked immunosorbent assays at the following storage durations: 0, 4, 9, 14, and 28 days. Frozen samples stored at -20°C for 28 and 56 days were also assayed. Also, a subset of aflibercept samples was stored and then diluted to 1:10 and progressively smaller concentrations and the assays repeated. Aggregation of aflibercept was tested using a dynamic light scattering assay. Results: There were no statistical differences in anti-VEGF activity among aflibercept samples of 1:1 or 1:10 dilution stored at either 4°C or -20°C at any of the storage intervals (P > 0.05). We also observed persistence of robust anti-VEGF activity for up to 14 days when diluted poststorage to 1:16,000, a concentration that would be expected after >7 vitreous half-lives within the eye (estimated at >50 days). No evidence of drug aggregation in specimens stored for 14 days was observed. Conclusions: Our findings support feasibility of prefilling and storage of aflibercept within manufacturer-supplied polycarbonate syringes for as long as 14 days before use under pharmacy-based sterile conditions, facilitating greater safety and efficiency in many clinics delivering anti-VEGF therapy.

Author List

Han DP, Skumatz C, Besharse JC, Kassem IS

Authors

Dennis P. Han MD Adjunct Professor in the Ophthalmology and Visual Sciences department at Medical College of Wisconsin
Iris S. Kassem MD, PhD Associate Professor in the Ophthalmology and Visual Sciences department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Angiogenesis Inhibitors
Drug Storage
Humans
Intravitreal Injections
Polycarboxylate Cement
Receptors, Vascular Endothelial Growth Factor
Recombinant Fusion Proteins
Vascular Endothelial Growth Factors