Study: Real-World Brolucizumab Inflammation/Retinal Vascular Occlusion Rate 2.4%

LONG BEACH, CA – APRIL 01: LONG BEACH, CALIF. USA –Tony Urbiha gets an injection from Dr. Stanley Carson in his Long Beach, Calif. office on June 8, 2011. Urbiha suffers from macular degeneration. Just a few years ago, people of all ages who had the degenerative eye disease were told that they would eventually go blind. Then came a breakthrough, a treatment that seems to halt and sometimes even slightly reverse the condition in one kind of macular degeneration. The treatments include frequent shots in the eyeball to prevents the progression of the disease. Patients come at regular intervals, and special cameras show the condition of the retina and whether a shot is required at that visit. (Photo by Jeff Gritchen/Digital First Media/Orange County Register via Getty Images)
The study found a history positive for intraocular inflammation or retinal vascular occlusion is a major risk factor for adverse events after brolucizumab treatment among patients with nAMD.

The real-world incidence rate of intraocular inflammation (IOI) and retinal vascular occlusion among patients who underwent brolucizumab therapy for neovascular age-related macular degeneration (nAMD) was found to be 2.4%, according to results published in JAMA Ophthalmology.

Data for this study were sourced from the American Academy of Ophthalmology’s Intelligent Research in Sight (IRIS) Registry and the Komodo Healthcare Map. Patients who received at least 1 brolucizumab injection between 2019 and 2020 for nAMD were assessed for IOI, including retinal vascular occlusion or retinal vasculitis (RV), or a combination.

A total of 9456 patients (n=10,654 eyes) from the IRIS and 9261 patients (n=11,161 eyes) from the Komodo databases met the inclusion criteria. Most patients were women (57.3% and 57.8%) and had undergone unilateral brolucizumab treatment (77.5% and 66.0%) among the IRIS and Komodo cohorts, respectively.

Among both cohorts, more than 90% of eyes had been switched to brolucizumab from another anti-vascular endothelial growth factor (anti-VEGF) agent, most commonly aflibercept.

Among participants from both data sets, 2.4% total demonstrated any form of IOI or retinal vascular occlusion,  and the median time from brolucizumab treatment to adverse event was 39 days (range 2-141 days) for participants from the IRIS registry and 56 days (range 2-168 days) for those from the Komodo dataset.

Prior to the first adverse event, 51.0% and 47.0% of eyes had only received a single injection, 38.0% and 40.3% had 2 injections, and 11.0% and 12.7% had 3 injections for the IRIS and Komodo eyes, respectively.

The total incidence rate of RV or retinal vascular occlusion, or both, was 0.6%. RV occurred among 0.2% and retinal artery occlusion occurred among 0.3%. Panuveitis occurred more frequently among the eyes in the IRIS group (0.3% vs 0.1%).

IOI and retinal vascular occlusion were both observed more among eyes with prior inflammation or occlusion (IRIS:8.7%; Komodo: 10.6%) and among women more than men (IRIS: 2.9% vs 1.3%; Komodo: 3.0% vs 1.4%).

This study was limited as investigators did not have access to imaging data.

The study authors concluded that the overall incidence rate of IOI or retinal vascular occlusion, or both, was 2.4%. A major risk factor for adverse events after brolucizumab treatment among patients with nAMD was prior IOI or retinal vascular occlusion.

Disclosure: This study was sponsored by Novartis Pharmaceuticals Corporation. Multiple study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.  


Khanani AM, Zarbin MA, Barakat MR, et al. Safety outcomes of brolucizumab in neovascular age-related macular degeneration: results from the iris registry and komodo healthcare map. JAMA Ophthalmol. Published online November 24, 2021. doi:10.1001/jamaophthalmol.2021.4585