Analysis of Brolucizumab Safety
Ophthalmology Retina, February 2022
Cases of retinal vasculitis and/or retinal vascular occlusion, typically occurring in the presence of intraocular inflammation (IOI), have been noted with the anti-VEGF agent brolucizumab. Because the HAWK and HARRIER trials comprise the most complete datasets for brolucizumab in neovascular age-related macular degeneration (AMD) at this time, Singer et al. evaluated IOI-related adverse events in these studies. They found that while most adverse events occurred within the first six months following brolucizumab injections, others occurred well after this time frame.
Of 1,088 eyes that received brolucizumab injections (3- and 6-mg cohorts combined), 49 demonstrated at least one IOI-related adverse event. Of these, 35 had one adverse event, while 14 had two or more, for a total of 70 adverse events. Twelve of the 49 eyes gained 15 or more letters of vision from baseline, nine lost 15 or more letters, and four lost 30 or more letters. Of note, seven eyes with poor visual outcomes also experienced retinal artery occlusion.
Thirty-eight of the 70 events were classified as mild, 28 were moderate, and four were severe. Sixty-one of the 70 IOI-related events were treated; treatment typically involved topical corticosteroids, with infrequent use of systemic and/or intraocular corticosteroids. Fifty-two of the 61 treated events were reported by the investigators as resolved. Another four events were reported as resolved with sequelae, and five had not resolved by the end of the study. Of the nine untreated adverse events, seven resolved completely, and two resolved with sequelae.
Most IOI-related adverse events occurred within six months of brolucizumab initiation and the first four injections. However, some were reported as late as 16 months after the first brolucizumab injection, after eight to 10 injections, and as late as 72 days after the last brolucizumab injection.
The original article can be found here.