Director Regeneron Pharmaceuticals Tarrytown, United States
Background: Intraocular inflammation (IOI) is an uncommon but potentially serious complication that may result from intravitreal injections of aflibercept and other anti-vascular endothelial growth factor treatments. Spontaneous reporting data for aflibercept suggest that the incidence of IOI may vary by ophthalmic dispensing device. However, the incidence of IOI in clinical practice is unknown.
Objectives: To evaluate the incidence of IOI following aflibercept injections administered from prefilled syringes (PFS) and vials over time in US clinical practice.
Methods: This retrospective cohort study was conducted using electronic health record data from the Vestrum Health Retina Treatment and Outcomes database. Data from patients aged ≥18 years who received ≥1 aflibercept injection between January 1, 2014, and June 1, 2022, were analyzed. IOI cases were assessed within 28 days of the index date (date of aflibercept injection). Annual incidences of all IOI, including a subset of suspected endophthalmitis, were calculated as cases per 100 injections administered overall and by ophthalmic dispensing device. Corresponding 95% confidence intervals were estimated using generalized estimating equations.
Results: Overall, 2,234,416 aflibercept injections, administered to 155,413 patients, were analyzed. Approximately 34% of all injections were PFS (available since December 2019). Mean (SD) age at time of injection was 75.0 (12.5) years; 55.5% of injections were given to female patients. The overall incidence of IOI (95% CI) decreased from 0.091% (0.054, 0.128) in 2014 to 0.028% (0.023, 0.035) in the partial year of 2022. A similar decrease was observed with the overall incidence of suspected endophthalmitis (0.083% [0.048, 0.119] in 2014 to 0.017% [0.012, 0.022] in the partial year of 2022). In 2020 and 2021, respectively, the incidence of IOI was 0.022% (0.016, 0.028) and 0.027% (0.021, 0.033) with PFS and 0.047% (0.037, 0.057) and 0.043% (0.032, 0.053) with vials. In the partial year of 2022, the incidence of IOI was 0.026% (0.019, 0.032) and 0.034% (0.022, 0.047) with PFS and vials, respectively. The incidence of suspected endophthalmitis in 2020 and 2021, respectively, was 0.014% (0.09, 0.019) and 0.013% (0.09, 0.017) with PFS and 0.028% (0.020, 0.036) and 0.029% (0.020, 0.037) with vials. In the partial year of 2022, the incidence of suspected endophthalmitis was 0.016% (0.011, 0.021) with PFS and 0.020% (0.010, 0.029) with vials.
Conclusions: Incidences of IOI and suspected endophthalmitis decreased from 2014 to the partial year of 2022. Incidences were lower with PFS than with vials in 2020 and 2021 with no conclusive difference in the partial year of 2022.
