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With every ophthalmic injection comes the responsibility of protecting vision, ensuring patient comfort, and safeguarding drug quality. Recognizing the importance of packaging development and prioritizing its role early in your drug program can help you overcome challenges associated with the unique demands of intravitreal products
The ophthalmic injectables market is expanding, driven by an aging population with eye conditions, better access to eye care, and a growing R&D pipeline. Market volumes are projected to grow 7% from 2026 to 2029, with nearly 70 intravitreal pipeline programs in development, double the number from 20151. Biosimilars are also expected to gain share from innovators.
As new therapies emerge, innovators must understand and address common challenges in this space include:
All are tied to patient safety, as contamination or improper dosing can lead to serious risks such as inflammation or vision impairment. Choosing the right packaging is critical to mitigating your risks of delays, delivery performance issues, or negative patient outcomes.
Developers face increasingly stringent regulatory specifications and tight acceptance criteria for particulates and endotoxins, often more restrictive than those for standard parenteral drugs. Key requirements for ophthalmic drug products are defined across pharmacopeial standards and regulatory guidance, including:
These expectations highlight the limitations of conventional plungers and syringes, which are typically not designed to meet the unique performance demands and quality standards of ophthalmic drug delivery.In addition to these ophthalmic requirements, developers must navigate regulatory changes in Europe, including:
These evolving requirements challenge developers to adopt high quality packaging and delivery solutions that not only perform reliably, but also stand up to heightened regulatory standards.
Silicone lubricants are commonly used in disposable and traditional prefilled syringes to enable smooth plunger movement. However, silicone oil poses well-recognized risks in ophthalmic applications. Over time, silicone oil droplets can migrate into the drug formulation, leading to floaters in a patient's eye and compromising their vision. Studies report that up to 11% of patients experience increased intraocular pressure related to foreign particles or aggregated, including those formed by silicone interactions2.
Silicone migration can lead to aggregation, drug interaction, and uneven lubricant distribution. This can result in excess silicone in some areas and exposed rubber surfaces in others, and ultimately inconsistent functional performance. These effects can directly impact glide force; the very parameter silicone is intended to improve, resulting in variability, unpredictability, and added risk to both performance and patient safety.
For ophthalmic products, regulatory expectations surrounding particulates and endotoxins are more stringent than in most therapeutic areas. Each step in the filling and handling process introduces the potential for foreign particles, whether from component preparation, washing, or sterilization. Traditional packaging solutions that worked well in other therapeutic areas may not adhere to the stricter requirements of ophthalmic applications. For drug developers, the risk of insufficient particulate and endotoxin control can have severe consequences that include:
In ophthalmology, microliter‑level dosing requires precision. Even slight variations in break‑loose or glide force can lead to inconsistent dosing, patient discomfort, or clinician frustration. Many conventional prefilled syringe components on the market were not designed for small volumes, which can cause developers to use larger systems, such as 1.0 mL syringes, that are not suited for ophthalmic dosing. This often results in common issues such as excessive glide‑force variability or increased dead space that wastes valuable drug product.
This inefficiency is especially costly in ophthalmology, where marketed intravitreal biologic drugs are nearly 2.5x more expensive than biologic delivered in other injection types, such as intramuscular or subcutaneous routes. Achieving precise and consistent dosing not only protects patients by ensuring they receive the intended therapeutic effect, but it also helps reduce avoidable waste of high‑value drugs.
West recently introduced the new ready-to-use 0.5mL plunger, built on the proven 4023/50 formulation within the NovaPure portfolio, West’s highest level of component quality. Developed using Quality by Design principles, this plunger is specifically engineered to meet the demanding requirements of ophthalmic therapies.
Features and benefits of the NovaPure 0.5mL plunger include:
This next generation plunger is designed to enhance product quality and reliability for the precise demands of ophthalmic delivery systems.
At West, we partner with innovators who are ready to move beyond traditional components and toward purpose‑built solutions designed specifically for ophthalmic drug delivery. West’s portfolio is gaining adoption across the industry, from emerging innovators to established biopharmaceutical leaders and biosimilar developers, supporting both new programs and packaging upgrades to support Annex 1 requirements or lifecycle improvements.
Our NovaPure 0.5mL plunger delivers confidence through:
With the NovaPure® 0.5 mL plunger, designed for glass delivery systems, West provides an engineered solution for evaluating your drug product, supporting patient safety while delivering the precision and performance required for today’s ophthalmic therapies.
Take the next step toward safer, more reliable ophthalmic delivery.
Contact us today or explore West’s Ophthalmic Solutions page to learn more about how we can support your molecule from development through commercialization.
This document is for informational purposes only. West’s products and solutions are sold on the basis that it is the customer’s responsibility to evaluate and test the West product or solution to determine its compatibility with other materials and fitness for any end use. WEST MAKES NO WARRANTIES, WHETHER EXPRESS, IMPLIED OR STATUTORY, INCLUDING, WITHOUT LIMITATION, THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PARTICULAR PURPOSE, RELATING TO THE INFORMATION IN THIS DOCUMENT.
NovaPure and FluroTec are trademarks or registered trademarks of West Pharmaceutical Services, Inc. in the United States and other jurisdictions.
1 Injectable pipeline data pulled on January 20,2026. Registration to Phase 2, Intravitreal Formats.
2 investigative Ophthalmology & Visual Science May 2017, Vol.58, 1893-1898. doi:10.1167/iovs.16-20786
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