Abstract
<title>Abstract</title> <p>Background Aflibercept 8 mg was developed to extend treatment intervals in neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Although pivotal trials reported low rates of intraocular inflammation (IOI), post-marketing sterile inflammatory events have been described. We report a same-day cluster of sterile endophthalmitis after vial-drawn intravitreal aflibercept 8 mg at a tertiary center. Methods This retrospective single-center study included all six consecutive patients who received vial-drawn intravitreal aflibercept 8 mg on one treatment day in May 2024. Serial examinations included best-corrected visual acuity (BCVA), intraocular pressure, slit-lamp biomicroscopy, and optical coherence tomography. Fluorescein angiography and vitreous microbiological testing were performed where indicated. Descriptive statistics were used. Results Five of six patients (83%) developed sterile endophthalmitis within 2–4 days (mean 3.0 ± 0.7 days), with blurred vision, floaters, anterior chamber cells, and vitritis; one patient developed hypopyon. Mean BCVA worsened from 0.44 ± 0.20 logMAR at baseline to 1.29 ± 0.88 logMAR at diagnosis. All affected patients received topical anti-inflammatory treatment with antibiotic coverage and cycloplegia; systemic corticosteroids were administered in four patients. The patient with hypopyon additionally underwent pars plana vitrectomy, anterior chamber washout, vitreous sampling, and intravitreal antibiotics. Vitreous cultures obtained from the patient who underwent pars plana vitrectomy were negative for bacterial and fungal pathogens, and fluorescein angiography in four patients showed no retinitis or vasculitis. At approximately 1 year, mean BCVA was 0.41 ± 0.20 logMAR; four eyes matched or exceeded baseline, while one showed a minor decline attributable to recurrent exudative activity. Same-day injections of other anti-VEGF agents in the same operating theatre were uneventful. Conclusions This same-day cluster supports sterile endophthalmitis as a clinically relevant post-marketing event after aflibercept 8 mg. The absence of comparable events after other same-day anti-VEGF injections argues against a general aseptic-procedure problem and suggests a product-, vial-, handling-, or batch-related factor. Prompt recognition, exclusion of infection when appropriate, anti-inflammatory treatment, and pharmacovigilance reporting are important.</p>