Clustered Sterile Intraocular Inflammation Tied to Intravitreal Aflibercept Injections
核心洞察
A single centre reported a clustered outbreak of sterile intraocular inflammation (搜索) involving three different aflibercept formulations over a 17-day period.
The cluster spanned the original 2-mg dose, the recently approved 8-mg dose and an aflibercept biosimilar, the first such outbreak described.
Inflammation resolved after syringe replacement, and severity varied by clinician, pointing to syringe handling and drug preparation as possible triggers.
A single centre has reported a temporally clustered outbreak of sterile intraocular inflammation (搜索) (IOI) following intravitreal aflibercept injections, involving three distinct aflibercept formulations over a 17-day period. The formulations were the original 2-mg dose, the recently approved 8-mg dose and an aflibercept biosimilar. Sporadic cases of aflibercept-associated IOI have been documented previously, and cases linked to high-dose aflibercept have recently emerged, but the authors state this is the first demonstration of a clustered outbreak involving the original, high-dose and biosimilar formulations at one centre.
Definitive causality could not be established. The authors point to the selective involvement of aflibercept, the absence of inflammation with other anti-VEGF agents, and the resolution of the outbreak following syringe replacement as evidence suggesting a formulation-specific vulnerability to particular injection-related triggers. Clinician-specific differences in inflammatory severity further indicate that procedural factors, especially syringe handling and drug preparation, may modulate the phenotypic severity of IOI.
Syringe-related mechanisms such as silicone oil microdroplets or protein aggregation remain biologically plausible but unproven. The authors note that post-injection IOI is increasingly viewed as multifactorial, arising from interactions among drug formulation, device-related materials and host immune pathways, and suggest that shared characteristics across aflibercept formulations compounded by procedural variables can trigger such clusters. They add that awareness of these safety signals may support earlier detection of similar outbreaks.
Source: Nature, Eye
