Short-Term Safety and Efficacy of Intravitreal Brolucizumab Injections for Neovascular Age-Related Macular Degeneration: A Multicenter Retrospective Real-World Study

Abstract

Introduction: To determine the short-term real-world safety and efficacy of intravitreal brolucizumab injections in Korean patients with neovascular age-related macular degeneration (nAMD). Methods: This multicenter retrospective study involved 294 eyes (treatment naïve 20 eye (6.8%) and non-treatment naïve 274 eyes (93.2%)) of 290 patients from 13 hospitals or retinal centers in South Korea. Patients with nAMD who received brolucizumab injection(s) between April 1 and November 30, 2021, with a follow-up ≥1 month, were included. Primary outcomes were safety, incidence of intraocular inflammation (IOI), and potential risk factors. The secondary outcome was efficacy, i.e., change in best-corrected visual acuity (BCVA) and optical coherence tomography-measured macular thickness and retinal fluid. Results: The mean age was 71.63±8.66. The follow-up period was 2.38±0.79 months. The mean number of brolucizumab injections during the follow-up was 1.52±0.58. The overall incidence of IOI was 13.9% (n=41 eyes). Most IOI cases were of anterior uveitis (8.8%, 26 eyes), followed by retinal vasculitis (2.4%, seven eyes) and occlusive retinal vasculitis (0.3%, one eye). Most eyes showed IOI resolution (n=40, 97.5%) and BCVA restoration (n=39, 95.1%) with or without corticosteroid treatment during the follow-up. Age, sex, IOI history, or other anti-vascular endothelial growth factor injection histories were not associated with the occurrence of IOI. However, only thin subfoveal choroidal thickness (SFCT) was associated with the occurrence of IOI (odds ratio=0.995, p=0.020). BCVA at 1 month improved from baseline (Baseline 0.518±0.356 vs. 1 month 0.503±0.383, p=0.023), but the improvement was not maintained. Anatomical improvement was significant after 3 months. Conclusion: IOI was well-controlled with or without steroid treatment. Most IOI eyes (95.1%) were restored to the level of vision before IOI occurrence and occlusive vasculitis was rare. In the short term, brolucizumab injection effectively improved vision at 1 month and dried retinal fluid for 3 months.

Incidence and Risk factors of Intraocular Inflammation after Brolucizumab Treatment in Japan: A Multicenter AMD Study

“…First, the study evaluated data from Japanese patients and these findings may or may not be relevant to similar races/ethnicities. The observed incidence of IOI was comparable to that reported in Korea, 26 suggesting potential similarities in these populations. Nevertheless, these results may not necessarily be generalizable to other ethnic groups.…”

“…In a multicenter retrospective report of 294 eyes of Korean patients, the incidence of IOI was 13.9%. 26 Thus, the incidence of IOI seems to be higher in East Asian populations than in the American population. In addition, based on the findings of this study, which provides the most reliable information for Japanese nAMD patients to date, we can summarize the findings as follows: IOI is most common after the first IVBr injection, with its incidence concentrated and gradually decreasing in the first 4 months after the last injection.…”

Switching from a Fixed Monthly Aflibercept Regimen to Bi-Monthly Brolucizumab in Refractory Cases of Neovascular Age-Related Macular Degeneration

“…Brolucizumab-associated IOI was reported to range from mild iritis/vitritis to severe retinal vasculitis with/without vascular occlusion and irreversible vision loss [ 48 , 49 ]. Although the HAWK and HARRIER trials reported higher rates of IOI with brolucizumab (4.6%) than with aflibercept, some clinical studies showed a higher incidence of IOI ranging between 13.9% and 19.0% [ 45 , 50 ]. In our study, the incidence of IOI is 6.3%.…”

Efficacy, Safety, and Durability of Brolucizumab: An 8-Month Post-Marketing Surveillance Analysis

“…The proportion of eyes with fluid in each of the intraretinal, subretinal, and sub-RPE compartments decreased following treatment with brolucizumab (Table 1D). The percentage of eyes with IRF in the fovea decreased from 30…”