Faculty Collaboration Database

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 Jun;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 (requires institutional sign-in at Scopus site)   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

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