Anti-vascular endothelial growth factor (VEGF) therapies have been revolutionary for the treatment of wet age-related macular degeneration (AMD), but unmet needs persist. Despite robust responses and visual gains in many patients with wet AMD, up to 30% can continue to lose vision over time for a variety of reasons. Of note, with long-term follow-up, more than half of patients with wet AMD may have vision worse than 20/40, which can limit their daily activities despite anti-VEGF treatment.
Brolucizumab was approved by the FDA in October 2019 for the treatment of wet AMD based on clinical trial data from phase III trials demonstrating that it provided robust visual gains and greater anatomical outcomes with a 3-month dosing interval after the initial loading dose until Week 48. However, published data have been limited regarding real-world characteristics and outcomes of patients with wet AMD treated with brolucizumab. “Phase III trials have shown that brolucizumab is an effective treatment option in wet AMD, with the potential to extend injection intervals,” says Rishi P. Singh, MD, from the Cleveland Clinic and Case Western Reserve University.
At the 2020 American Academy of Ophthalmology Annual Meeting, a team of investigators—which included Dr. Singh as well as Marco A. Zarbin, MD, PhD, FACS; Charles C. Wykoff, MD, PhD; and Mathew W. MacCumber, MD, PhD; among others—presented data from a study assessing real-world baseline characteristics and early outcomes of patients with wet AMD who initiated treatment with brolucizumab. Data were reviewed on patients who from the IRIS® Registry and the Komodo databases. The IRIS® Registry provides data on more than 600,000 patients with wet AMD, more than 12,000 of which were on brolucizumab. The Komodo database includes more than 545,000 patients with wet AMD, more than 10,000 of which were on brolucizumab. Inclusion criteria included receipt of one or more brolucizumab injections beginning on October 8, 2019.
According to the study results, the majority of wet AMD patients from the IRIS® Registry and Komodo databases who initiated treatment with brolucizumab switched from a prior anti-VEGF agent. More than 70% switched from aflibercept, while others had previously received ranibizumab or bevacizumab. “This finding suggests that unmet vision needs continue for many patients with wet AMD who receive current anti-VEGF therapies,” says Dr. Singh.
In addition, the study demonstrated that the overall incidence of all forms of intraocular inflammation (IOI)—including retinal vasculitis (RV) —and/or retinal vascular occlusion (RO) was 2.39% and 2.40%, respectively, among patient eyes after brolucizumab treatment in the IRIS® Registry and Komodo database. The overall incidence of RV and/or RO was observed at 0.54% and 0.56%, respectively. Of note, patients with IOI and/or RO in the 12 months prior to their first brolucizumab injection had the highest observed risk rate for an event of IOI and/or RO among eyes in the 6 months after their first brolucizumab treatment.
“With so many patients switching treatment to brolucizumab, this research highlights the patients for whom we should be most concerned about having an adverse event, including IOI including RV,” says Dr. Singh. “Namely, the research showed that those with prior IOI event in the past 12 months have the highest risk and, thus, should not be candidates when considering switching to brolucizumab from other anti-VEGF agents.”
Zarbin MA, et al. Profiles and Early Outcomes of Patients Who Initiated Brolucizumab for Neovascular (Wet) AMD in the IRIS® Registry. Presented at: American Academy of Ophthalmology 2020 Virtual Congress. Session: PO395. November 2020. Available at: https://aaommg.apprisor.org/apsSession.cfm?id=PO395.
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