IPI speaks with Yuki Takeuchi on requirements and trends in ophthalmic drug delivery, and Terumo’s solutions in the segment focusing on their primary container platform PLAJEXTM
Q: Can we start by telling our readers how long has Terumo been involved in the Ophthalmic Drug Delivery segment, and what are your biggest accomplishments in this area?
A: We became aware of the market needs for improved ophthalmic drug delivery solutions in 2015 through market survey and interaction with pharmaceutical customers. Since then, we kept working on understanding the challenges and requirements for patients, healthcare professionals, pharmaceutical companies, as well as regulatory authorities, and reflected these requirements into our product development program. As the result, we succeeded in developing a new ready-tofill syringe solution addressing the market challenges, and it triggered high interests from multiple pharmaceutical customers for their ophthalmic drug development activities.
The biggest accomplishment so far is the product launch of our PLAJEX 0.5mL Luer Lock silicone oil-free syringe which addresses challenging low dose applications such as ophthalmic drugs. The product launch was achieved in May 2022 after successfully implementing product design improvements as well as process improvements on our early-phase solutions. Our next milestones would be customer’s drug product launch to the market with PLAJEX, which will enable our primary container solution to contribute to ophthalmic drug delivery for patients in actual clinical scenes.
Q: You mentioned that you worked on capturing the market challenges and requirements in ophthalmic drug delivery. Can you explain what you learned from it?
A: One of the important challenges in the ophthalmic drug delivery we identified is silicone oil which is injected to patient’s eyes through intravitreal injection. Traditionally, silicone oil has been used as a lubricant for syringes to facilitate smooth movement of the plunger stopper within the syringe barrel. However, in case of ophthalmic drugs, it has been shown that silicone oil can be deposited in the eye’s vitreous humour and accumulate after repeated injections. Silicone oil droplets that remain in the eye and are visible to the patient are commonly referred to as “floaters” and avoiding them is one of the key considerations for intravitreal injection treatments. For verifying the problem statement, we conducted several interviews with ophthalmologists in the US as a part of a formative human factor study. The interviews showed that most of them are concerned about silicone oil in the syringe which they use for intravitreal injections.
Related to that, ophthalmic drugs are required to follow stricter requirements compared with other parenteral drugs. For example, USP<789> “Particulate Matter in Ophthalmic Solutions” requires ophthalmic drug products to have no more than 50 particles sized ≥10μm per mL, and no more than five particles sized ≥25μm per mL. Silicone oil is also known to be detected as a particle in this context and to have the potential to induce protein aggregation, which further increases particle counts in drug products.