Intravitreal injections involve direct delivery into a highly sensitive area, presenting additional requirements and challenges compared to conventional parenteral injections, such as subcutaneous or intramuscular. Careful consideration is essential in selecting an appropriate drug delivery system to ensure the safe and effective treatment of eye disorders.
Among others, one of the most challenging requirements for the MAH (Market Authorization Holder) is the compliance to USP<789> regarding sub-visible particles for ophthalmic injection. In comparison, USP<789> is x10 more stringent than USP<788> applicable for parenteral injection. Terumo will present how this challenge can be addressed by selecting the right technology for the delivery system. This holistic approach applies not only to the syringe but also to the hypodermic needles.
Terumo will show how the use of advanced coating technology, as an alternative to standard sprayed medical grade silicone oil for lubrication, can significantly reduce intrinsic particles, which are often a result of barrel lubricants such as silicone oil. This helps the MAH to comply with the Pharmacopeia and deliver a safer drug product on the market.
Injection needles are the second essential element for curative treatment by parenteral drug applications into the vitreous. The offer of regulatory compliant products is currently limited. Field safety reports by manufacturers indicate frequent off-label use of devices restricted to the hypodermic tissues. This is a compromise found by health care professionals to mitigate the lack of suited supplies.
Terumo successfully validated a new injection needle designed for intravitreal injections, in addition to its use for hypodermic applications. This novel needle also features an integrated 5µm mesh-size filter, intended to prevent particles of intrinsic or extrinsic origin from being injected into the vitreous.
The combination of silicone oil-free prefillable syringes and injection filter needles allows developers and manufacturers of vision-preserving drugs to deliver their medications to the market in a complete and effective manner.
Terumo will demonstrate how to build such an end-to-end solution.
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