Gore Launches Silicone-Free 0.5-mL Plunger

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.

Designed for Intravitreal and Ophthalmic Drug Delivery Applications

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.

Addressing Silicone-Related Risks in Ophthalmology

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:

• Elevated subvisible particulate levels

• Silicone accumulation in the eye, contributing to floaters

• Silicone-induced protein aggregation, potentially triggering immunologic responses

• Ocular inflammation and elevated intraocular pressure

• Increased particle counts and fatty acid formation over time

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.

Engineered to Align with Industry Standards

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:

• Break loose and glide force

• Container closure integrity

• Compatibility with commercial fill-and-finish processes

Industry Collaboration and Vision for Patient Safety

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’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.

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.”