Author: Morten C. Moe (Norway)
Co-authors: Torleif T. Gjølberg, Heidrun E. Lode, Gustavo B Melo, Christine Probst, Øystein K. Jørstad, Jan Terje Andersen
Purpose
Despite numerous reports of symptomatic deposition of silicone oil (SiO) droplets in the vitreous body, syringes lubricated with SiO are extensively used for intravitreal injections (IVIs) of antibody-based biologics. To address this adverse event, we aimed to develop a SiO-free syringe with no dead volume specifically designed for IVIs. The aim of this study was to investigate the properties of this syringe.
Setting/Venue
Preclinical laboratory testing.
Methods
We describe the unique properties of the novel syringe based on its quality, stability and functional properties, including binding to VEGF following pharmaceutical compounding and storage for up to 30 days of aflibercept, ranibizumab, and bevacizumab. The compounding was performed at the hospital pharmacy in accordance with a validated aseptic production procedure, conforming to European regulations. Particle release was assessed by imaging flow cytometry, and the new syringe was compared, with and without agitation, to both a siliconized insulin syringe commonly used for IVIs and a standard SiO-free syringe. Further, we compared the new syringe with commercially prefilled syringes (PFS) with ranibizumab and aflibercept.
Results
Compounding and storage of aflibercept, ranibizumab, and bevacizumab in the new syringe for up to 30 days did not compromise protein concentration, aggregation, or binding to VEGF. The new syringe also demonstrated a favourable safety profile regarding particle release compared to the other syringes, including PFS with aflibercept and ranibizumab.
Conlusions
We describe the properties of a new SiO-free syringe that allows for pharmaceutical compounding and storage of anti-VEGF antibody-based biologics for up to 30 days without compromising their functional binding properties. The novel syringe is an appealing alternative to SiO-lubricated syringes.
Financial Disclosure
M.C.M, G.B.M., M.S.S., Ø.K.J. and J.T.A. are part of collaborative agreements related to development of the syringes presented by SJJ Solutions. M.C.M. has been a member of advisory boards at Bayer, Novartis, Roche and Allergan and has received lecture fees from Bayer and Roche. Ø.K.J. has been member of Bayer, Allergan, and Roche advisory boards and has received lecture fees from Bayer and Allergan. The remaining authors have no relevant competing financial interest to declare.
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