W. L. Gore & Associates (Gore) has announced the launch of its silicone-free GORE IMPROJECT Plunger for 0.5-mL pre-filled syringes, developed specifically for use in ophthalmic drug delivery applications, particularly intravitreal injections. This new plunger is designed to address the unique demands of particle- and silicone-sensitive therapies, with a primary focus on retinal drugs and growing relevance in gene therapy..

W. L. Gore & Associates (Gore) 宣布推出其专为眼科药物输送应用（尤其是玻璃体内注射）开发的无硅 GORE IMPROJECT 0.5 毫升预灌封注射器柱塞。这款新型柱塞旨在满足对颗粒物和硅敏感疗法的独特需求，主要聚焦于视网膜药物，并在基因治疗中日益受到关注。

Designed for Intravitreal and Ophthalmic Drug Delivery Applications

用于玻璃体内和眼科药物递送应用的设计

The 0.5-mL GORE IMPROJECT Plunger complements Gore’s existing 1-mL IMPROJECT plunger, which was launched in mid-2018. This new version is tailored to smaller volume delivery, such as those used in ophthalmic injections. Unlike conventional pre-filled syringe systems that rely on silicone to create a seal and reduce friction, Gore’s silicone-free alternative eliminates the risks associated with silicone contamination in ophthalmic drug administration..

0.5毫升的GORE IMPROJECT推杆补充了戈尔公司现有的1毫升IMPROJECT推杆，后者于2018年年中推出。这个新版本专为较小剂量的注射设计，例如用于眼科注射。与依赖硅油来形成密封并减少摩擦的传统预充式注射器系统不同，戈尔的无硅替代品消除了硅油污染在眼科药物注射中的相关风险。

Addressing Silicone-Related Risks in Ophthalmology

眼科中与硅胶相关的风险处理

The new plunger is positioned as a safer alternative to traditional syringe systems. Clinical and scientific literature has documented complications arising from the use of silicone in ophthalmic syringes, including:

新型柱塞被定位为传统注射器系统的更安全替代品。临床和科学文献已经记录了使用硅油眼科注射器引起的并发症，包括：

• Elevated subvisible particulate levels

• 升高的亚可见颗粒水平

• Silicone accumulation in the eye, contributing to floaters

• 眼睛中的硅酮积聚，导致飞蚊症

• Silicone-induced protein aggregation, potentially triggering immunologic responses

硅酮诱导的蛋白质聚集，可能触发免疫反应

• Ocular inflammation and elevated intraocular pressure

• 眼部炎症和眼内压升高

• Increased particle counts and fatty acid formation over time

随着时间的推移，颗粒计数和脂肪酸形成增加

By eliminating silicone from both the plunger and syringe barrel (when used with compatible components), Gore’s solution aims to reduce these risks, supporting better patient outcomes in delicate ocular applications.

通过从柱塞和注射器筒中去除硅酮（当与兼容组件一起使用时），戈尔的解决方案旨在降低这些风险，从而在精细的眼部应用中支持更好的患者治疗效果。

Engineered to Align with Industry Standards

专为符合行业标准而设计

According to Gore, the new plunger is engineered to help syringe systems achieve particulate levels below the USP <789> subvisible particle standard. It can also be terminally sterilized and has demonstrated favorable results in terms of:

根据戈尔的说法，这款新式柱塞旨在帮助注射器系统达到低于美国药典<789>亚可见颗粒标准的颗粒水平。该柱塞还可以进行最终灭菌，并在以下方面表现出优异的结果：

• Break loose and glide force

• 松动并滑动力

• Container closure integrity

容器密封完整性

• Compatibility with commercial fill-and-finish processes

• 与商业填充和完成工艺的兼容性

Industry Collaboration and Vision for Patient Safety

行业合作与患者安全愿景

The development of the GORE IMPROJECT 0.5-mL plunger involved collaboration with pharmaceutical companies, contract manufacturing organizations (CMOs), sterilization providers, fill operation equipment designers, and syringe barrel manufacturers. This multidisciplinary approach helped ensure the product meets end-to-end requirements across the pharmaceutical value chain..

GORE IMPROJECT 0.5毫升柱塞的开发涉及与制药公司、合同制造组织 (CMO)、灭菌服务提供商、灌装操作设备设计师以及注射器筒制造商的合作。这种多学科的方法有助于确保产品在整个制药价值链中满足端到端的需求。

“Gore’s 0.5-mL plunger, in combination with a silicone-free glass or advanced polymer syringe barrel, enables pharmaceutical companies to achieve what they’ve been asking for—to reduce the risk associated with silicone by enabling its removal from the syringe plunger and barrel,” said Emily Oliver, Gore Syringe Business Leader..

“戈尔的0.5毫升柱塞与无硅玻璃或高级聚合物注射器筒相结合，使制药公司能够实现他们一直以来的要求——通过将硅从注射器柱塞和筒中移除来降低与硅相关的风险，”戈尔注射器业务负责人艾米丽·奥利弗表示。

Russ Hornung, Business Development Manager at Gore, added, “This is a breakthrough solution for the industry and was designed with the goal of improving patients’ lives.”

戈尔公司业务发展经理Russ Hornung补充道：“这是行业的一项突破性解决方案，旨在改善患者的生活。”