Aflibercept-Related Sterile Intraocular Inflammation Outcomes

Purpose: A recent increase in sterile intraocular inflammation after aflibercept (EYLEA; Regeneron Pharmaceuticals, Inc, Tarrytown, NY) injection was reported to the American Society of Retina Specialists' Research and Safety in Therapeutics Committee. This study describes their clinical characteristics and outcomes.

Design: Case series.

Participants: Sixty-eight eyes of 66 patients (97% reported from May 2017 through February 2018).

Methods: Exclusion criteria were intravitreal antibiotic injection and follow-up of less than 7 days. Diagnosis was at each physician's discretion.

Main outcome measures: Presenting signs and symptoms, injection characteristics, management details, and visual outcomes.

Results: Mean time to presentation was 2.6 days (median, 2.0 days; range, 0-15 days). Symptoms included blurry vision (93%), floaters (60%), pain (44%), severe pain (6%), and photophobia (19%). Mean visual acuities before and after injection were 20/50 and 20/178, respectively. All patients showed intraocular inflammation: 24% with only vitritis, 16% with only anterior chamber reaction, and 60% with both. Less common findings included keratic precipitates (22%), corneal edema (13%), conjunctival injection (10%), chemosis (4%), hypopyon (4%), and fibrin (3%). Two patients were affected bilaterally. Treatment included topical steroids (93%), with 1% supplemented by oral steroids. Inflammation resolved in 79% at study completion (mean, 34 days; range, 7-105 days; 51% resolved by 1 month). This group's mean final visual acuity (VA) was 20/55, and 15% lost 2 lines or more. This vision loss was associated with shorter time to presentation (P < 0.0001), magnitude of decrease in presenting VA (P = 0.0004), presence of fibrin (P = 0.02), and trended toward receiving only observation (P = 0.10). There were no other presenting factors that significantly affected visual outcome. In patients with unresolved inflammation at the final visit, mean follow-up was 29 days, and mean final VA was 20/118. Overall, 26 aflibercept lots were involved.

Conclusions: This is the largest study of aflibercept-related sterile intraocular inflammation, and is the only large report to exclude eyes injected with intraocular antibiotics. Most patients presented early with decreased VA and intraocular inflammation, but without injection, hypopyon, fibrin, or severe pain. Final VA remained decreased in a significant minority of patients.