PDF(Pubmed)
Abstract：
Intravitreal injections (IVI) of biologics targeting vascular endothelial growth factor (anti-VEGF) led to a paradigm shift in the management and prognosis of prevalent retinal conditions. Yet, IVI are typically performed with syringes that are neither developed nor approved for this purpose. Notably, syringes lubricated with silicone oil (SiO) are extensively used despite multiple reports showing that such syringes can cause deposition of SiO droplets in the vitreous body and patient discomfort. Thus, there is a need for SiO-free substitutes specifically tailored for IVI. Here, we report on the development and testing of such a syringe. This syringe has no dead volume, and its design allows for high-accuracy dosing. Also, it permits pharmaceutical compounding and storage of bevacizumab, ranibizumab, and aflibercept for up to 30 days without compromising their functional binding or transport properties. Finally, the new syringe demonstrated a favorable safety profile regarding release of SiO compared to SiO lubricated alternatives, including commercially prefilled syringes. Accordingly, the newly developed syringe is an appealing alternative for IVI.
摘要：
针对血管内皮生长因子（抗VEGF）的生物制剂的玻璃体内注射（IVI）导致了普遍存在的视网膜疾病的管理和预后的范式转变。然而，IVI通常使用既未开发也未批准用于此目的的注射器进行。值得注意的是,用硅油(SiO)润滑的注射器被广泛使用,尽管多个报道显示这种注射器可引起玻璃体中SiO液滴的沉积和患者的不适。因此，需要专门为IVI定制的无SiO替代品。这里,我们报告了这种注射器的开发和测试。这个注射器没有死体积,和它的设计允许高精度的剂量。此外，它允许贝伐单抗的药物复合和储存，雷珠单抗,和aflibercept长达30天，而不会损害其功能结合或运输特性。最后,与SiO润滑的替代品相比，新型注射器在释放SiO方面表现出良好的安全性，包括商业预充式注射器。因此，新开发的注射器是一个有吸引力的替代IVI。
