Intraocular Inflammation, Retinal Vascular Occlusion Infrequent in Treatment With Brolucizumab

A study published in Ophthalmology and Therapy found that treatment with brolucizumab had a low incidence of intraocular inflammation (IOI), retinal vascular occlusion (RO), and retinal vasculitis (RV) in patients with neovascular age-related macular degeneration (nAMD). Eyes with adverse effects (AEs) also had no major vision change.

Brolucizumab is an anti–vascular endothelial growth factor (anti-VEGF) therapy used to treat nAMD. A safety signal for both RV and RO has been linked to brolucizumab. Previous studies have evaluated the safety outcomes of brolucizumab in terms of incidence of IOI but the median follow-up period is only 3 months. The present study aimed to assess longer-term real-world safety outcomes when using brolucizumab, including incident and ocular safety events over a 2-year follow -p period.

Close-up of eye | Image credit: rangizzz - stock.adobe.com

This study used the Intelligent Research in Sight (IRIS) Registry from the American Academy of Ophthalmology, which contains patient data for different eyes in an electronic health record of several clinics across the United States. Eyes were identified if they had received their first anti-VEGF injection of brolucizumab from October 8, 2019, to October 7, 2021. Eyes 18 years and older at first injection, that had a diagnosis of nAMD in the 36 months before or on the index date, and that had a known disease laterality after the index injection were included in the study. Patients were excluded if they received brolucizumab prior to October 8, 2019.

Patients were divided into 2 groups: those who had an injection within the first year of the treatment’s approval in the US and those who received an injection in the second year. The last follow-up occurred on September 30, 2022. IOI, RV, and RO were all evaluated in this study. The number of patient eyes that had an AE of interest acted was the primary outcome. Time to event from the index date, the number of brolucizumab injections, and changes in visual acuity (VA) were also evaluated.

There were 18,312 patient eyes included in this study, with 89.0% of eyes receiving brolucizumab within the first year of the launch of the treatment. Treatment-naïve eyes were more common in patients in the year 2 subgroup. The year 2 subgroup also had a lower VA score and more patients with an Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score of 35.

IOI, RV, and/or RO was experienced in 3.4% of all patients after up to 2 years of follow-up following the first injection. A total of 3.1% of patients who received treatment in both eyes had any of IOI, RV, and/or RO. A median (IQR) of 84 (42-167) days was seen between each event. The first 3 months saw 53.7% of the events and the first 6 months saw 77.4% of all events. Patients had a median of 2 (1-4) injections before 58.5% of the events.

The overall incidence of RV and/or RO was 0.5%, with 99 (56-181) days being the median time to an event. Forty-three percent occurred within 3 months and 75.0% occurred in 6 months. The subcohort analysis found that the incidence of any of IOI, RV, and/or RO events was 3.1% for the year 1 group and 2.6% in the year 2 group.

Data on VA were available in 66.1% of eyes in the full cohort. The researchers found a median change in EDTRS score of 0 (–7 to 5). A total of 12.3% of patients saw a decrease in EDTRS score by at least 10 letters compared with their pre-event score.

There were some limitations to this study. The researchers relied on diagnostic codes to find instances of IOI, RV, and RO in the electronic health record. Also, the change in characteristcs of the patient population could have affected the findings, and approximately one-third of the eyes did not have pre-event and/or follow-up data for VA.

The researchers concluded that 3.4% of eyes experienced IOI, RV, and/or RO in a long-term follow-up study of brolucizumab treatment and VA was not negatively affected by these AEs. Safety outcomes for the treatment will evolve as more is learned about the treatment and its long-term effects.

Reference

Zarbin MA, MacCumber MW, Karcher H, et al. Real-world safety outcomes with brolucizumab in neovascular age-related macular degeneration: findings form the IRIS registry. Ophthalmol Ther. Published online March 23, 2024. doi:10.1007/s40123-024-00920-3