Syringe agitation may contribute to silicone oil dispersion after pegcetacoplan injection
Click Here to Manage Email Alerts
Key takeaways:
- Multiple small floaters were reported by one patient after pegcetacoplan injection.
- The authors reviewed the potential association with syringe-related silicone oil droplets.
A research letter published in JAMA Ophthalmology described the case of a patient with geographic atrophy who reported multiple small floaters after intravitreal injection of pegcetacoplan.
The patient was seen 2 weeks after injection but said that the floaters were present from the first day after the treatment. Clinical examination revealed multiple syringe-related silicone oil droplets, showing as hyperechogenic areas on B-scan ultrasonography.
According to the authors, the problem may originate from the act of filling the syringe according to the label instructions for pegcetacoplan, which suggest that the syringe should not be tapped to remove air bubbles. Instead, while maintaining the filter needle within the vial, it should be inverted, moving the plunger down and up until bubbles migrate to the top. However, because most syringes are lubricated with silicone oil, these repeated up-and-down movements may cause silicone oil droplets to be dislodged from the syringe wall and from the dead space, resulting in dispersion into the drug and injection into the eye.
One way to mitigate this occurrence is to consider using silicone-free Luer lock syringes, the authors suggested.
“Alternatively, a filtered vial adaptor, as used in pegcetacoplan’s phase 3 studies, may simplify drug removal with the vial inverted so that gas bubbles may remain at the syringe tip where they can be more easily expelled before [intravitreal injection],” they wrote.
Perspective
Back to Top
Gustavo Barreto de Melo, MD, PhD, FASRS
This case report delves into a pivotal and frequently underestimated concern surrounding intravitreal injections (IVI). In light of the substantial global number of IVI procedures, even ostensibly minor issues demand our attention. The presence of silicone oil (SO) droplets in the vitreous of a patient after a single pegcetacoplan injection is similar to what has been known in the literature for any anti-VEGF agent. Although some of the drug’s physical and chemical properties may play a role in the amount of SO released, the handling of the syringe itself alongside its manufacturing process are the main reasons for such problems.
The authors have posited that the reciprocating motion of the plunger during IVI may have the potential to displace SO from the syringe, particularly when administered alongside the final volume of the medication. While this hypothesis exhibits logical appeal, our research group conducted a study that, regrettably, failed to empirically substantiate that such movements may trigger supplementary SO release. However, it is well established that any form of agitation assumes a critical role in the dispersion of SO, spanning from the conventional flicking or tapping actions to incidental shocks and mishandling incidents during the product’s journey from manufacturing to distribution and eventual utilization by end users. This is also particularly worrisome when prefilled syringes are involved.
One should bear in mind that the 2018 ASRS Preferences and Trends Survey showed that about a third of U.S. retina specialists had encountered patients manifesting SO droplets after IVI, 5% had resorted to vitrectomy to address symptomatic floaters, and 1.8% had seen patients initiating legal actions stemming from these complications. Unlike prior knowledge from the initial anti-VEGF era, recent publications have unmasked a considerably higher prevalence of SO presence in the vitreous, affecting up to 80% of eyes undergoing routine IVI.
Furthermore, the authors advocate for the adoption of SO-free syringes for IVI, an idea I endorse. Undoubtedly, it is incumbent upon prominent stakeholders within this domain to facilitate the widespread availability of superior quality, ophthalmology-tailored, SO-free syringes. I should also point out that some high-quality siliconized syringes release a minimal amount of SO. Although we should target no SO at all, the better quality syringes that are commercially available on the market should be pursued.
References:
Bijon J, et al. JAMA Ophthalmol. 2023;doi:10.1001/jamaophthalmol.2023.3495.
García SB, et al. BMC Ophthalmol. 2022;doi:10.1186/s12886-022-02536-2.
Gerhardt A, et al. J Pharm Sci. 2014;doi:10.1002/jps.23973.
Kim NA, et al. Int J Pharm. 2020;doi:10.1016/j.ijpharm.2020.119704.
Melo GB, et al. Acta Ophthalmol. 2021;doi:10.1111/aos.14838.
Melo GB, et al. Br J Ophthalmol. 2020;doi:10.1136/bjophthalmol-2019-313823.
Melo GB, et al. Int J Retina Vitreous. 2019;doi:10.1186/s40942-019-0184-9.
Melo GB, et al. Prog Retin Eye Res. 2021;doi:10.1016/j.preteyeres.2020.100862.
Stone TW, et al. ASRS 2018 preferences and trends membership survey. Presented at: American Society of Retina Specialists annual meeting; July 26-30, 2019; Chicago.
Thompson JT. Ophthalmol Retina. 2020;doi:10.1016/j.oret.2020.07.021.
Collapse
Read more about
Click Here to Manage Email Alerts