Incidence and Clinical Course of Intraocular Inflammation Following Pharmacy-Compounded Intravitreal Aflibercept 8mg for Neovascular AMD: A Real-World Cohort Study.

Abstract

Purpose: To evaluate the incidence and clinical course of intraocular inflammation (IOI) after intravitreal aflibercept 8 mg (Eylea 8 mg - E8) injection in patients with neovascular age-related macular degeneration (nAMD) in Poland.

Patients and methods: This retrospective study included 867 eyes of 867 patients (591 female, 276 male) with nAMD treated with E8 at the 10^th Military Hospital in Bydgoszcz between January and December 2025. Of these, 655 patients were switched from other intravitreal agents and 212 were treatment-naïve. A total of 3441 E8 injections were administered before IOI onset, with two full 0.07mL (8mg) doses withdrawn from each single-use vial through pharmacy compounding. IOI severity was graded using the Standardization of Uveitis Nomenclature (SUN) criteria, and clinical course and outcomes were analyzed over 6 months of follow-up.

Results: IOI occurred in 20 patients, corresponding to an incidence of 2.31% per eye/patient and 0.58% per injection. Symptoms appeared a mean of 3.3 ± 1.9 days after injection, with decreased visual acuity (BCVA dropped from 0.22 ± 0.10 to 0.58 ± 0.45 logMAR, p=0.0005). All cases were managed with topical corticosteroids, 16/20 additionally received sub-Tenon triamcinolone, and 6 required oral prednisolone; 1 patient required pars plana vitrectomy. Nineteen patients resolved on medical therapy alone, while one patient required surgical intervention (pars plana vitrectomy) to achieve resolution. No retinal vasculitis occurred, and central retinal thickness remained stable during follow-up.

Conclusion: In this first Polish cohort study, the incidence of IOI after E8 injection (2.31% per eye/patient) was higher than reported in registration trials, though episodes were generally mild and self-limited, without long-term visual impact. These findings may help inform clinical monitoring for patients receiving E8 for nAMD.