Abstract
BACKGROUND: Real-world data on intraocular inflammation (IOI) following aflibercept 8 mg is limited. We report on a cluster of 12 eyes with aflibercept 8 mg-associated IOI detected at three centres between July 2024 and June 2025. METHOD: Primary outcome measures of the retrospective observational study were the classification of severity according to the SUN classification and the determination of the incidence of aflibercept 8 mg-associated IOIs. The inclusion criterion was on-label therapy in treatment-naive and patients switched to aflibercept 8 mg who developed sterile inflammation within 1 to 14 days after injection without a history of uveitis. Data was collected by means of medical history, clinical biomicroscopic examination, optical coherence tomography and fluorescein angiography. The incidence was calculated based on the number of injections performed at the three centres between July 2024 and March 2025. RESULTS: The case series comprises 12 eyes from 10 patients (7 women, 3 men) with post-injection IOI after an average of 1.9 days (SD: 0.6); nAMD (80.0%) / DME (20.0%). IOI occurred on average after 2.3 injections (SD: 1.6), with 91.7% pretreated without IOI event (including aflibercept 2 mg (66.7%)). Anterior uveitis developed in 16.7%, intermediate uveitis in 66.7% and posterior uveitis in 16.7%. The incidence was 1.4% per aflibercept 8 mg injection (11 eyes out of 775 injections; 95% CI: 0.6–2.2%). CONCLUSION: Initial real-world data indicate a slightly increased risk of IOIs with aflibercept 8 mg compared to the pivotal studies, some of which are fulminant and difficult to distinguish from endophthalmitis.