Clinical Characteristics and Outcomes of Eyes with Intraocular Inflammation after Brolucizumab: Post Hoc Analysis of HAWK and HARRIER.

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This analysis of the pivotal phase III HAWK and HARRIER trials aimed to provide insights on the timing of presentation, management, and outcomes of intraocular inflammation (IOI)-related adverse events (AEs), as reported by investigators in these trials.Post hoc analysis of investigator-reported IOI-related AEs in HAWK and HARRIER.Of 1088 brolucizumab-treated eyes (3 mg or 6 mg), 49 eyes experienced at least 1 IOI-related AE and were included in this analysis.Reports of IOI-related AEs were analyzed and descriptive statistics were provided for outcome measures.Incidence and description of eyes with IOI-related AEs, timing of presentation, management, clinical outcomes, and brolucizumab treatment after the first IOI-related AE.A total of 70 IOI-related AEs were reported in 49 eyes. Prior to the onset of first IOI-related AE, eyes received a mean (standard deviation [SD]) of 3.9 (2.2) brolucizumab injections. Median (25th-75th percentile) time to first IOI-related AE from the last administered brolucizumab injection was 18.0 (4.0-29.0) days. Of the 70 AEs, 61 (87.1%) were treated, the majority with topical corticosteroids; systemic and intraocular corticosteroids were used for 3 AEs each. Overall, inflammation resolved completely in 39 (79.6%) eyes, resolved with sequelae in 5 (10.2%) eyes, and did not resolve in 5 (10.2%) eyes by end-of-study. Overall, mean (SD) best-corrected visual acuity (BCVA) change from baseline to end-of-study, before AE to the lowest BCVA in 3 months after AE, and from before AE to end-of-study were -0.84 (20.6), -16.31 (17.6), and -0.22 (18.9) ETDRS letters, respectively. Of the 36 (73.5%) eyes that continued on brolucizumab after first IOI-related AE, 24 completed the trials and 12 discontinued; mean (SD) BCVA change in these eyes was 2.6 (17.6), 7.8 (13.2), and -7.7 (21.3) ETDRS letters, respectively, from baseline to end-of-study. The remaining 13 (26.5%) eyes were not treated with brolucizumab after first IOI-related AE and had mean (SD) BCVA change of -10.4 (25.5) ETDRS letters from baseline to end-of-study.Findings of this analysis highlight the need for continued vigilance and monitoring for any signs of IOI-related events in patients receiving brolucizumab.

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Authors: Michael Singer, Thomas A Albini, András Seres, Caroline R Baumal, Soumil Parikh, Richard Gale, Peter K Kaiser, Iryna Lobach, Nicolas Feltgen, Mayur R Joshi, Focke Ziemssen, Bahram Bodaghi