Mixed Results in Ongoing Brolucizumab Study for nAMD

Nikolas London, MD

Investigators have presented real-time findings testing brolucizumab in patients suffering from neovascular age-related macular degeneration (nAMD) in an effort to close some of the common unmet needs of this patient population.

A team, led by Nikolas London, MD, Retina Consultants San Diego, are evaluating the efficacy of brolucizumab in addressing the unmet needs of patients who continue to suffer from the disease despite treatment in findings at the American Society of Retina Specialists 2020 (ASRS 2020) Virtual Sessions.

Anti-VEGF agents have improvement the treatment of nAMD. Currently, the standard of care includes intravitreal-administered anti-VEGF therapies, such as aflibercept, ranibizumab, and bevacizumab to inhibit neovascular growth and fluid accumulation in the macula.

However, there is currently a lack of evidence showing that patients lose visual acuity over time because of the high treatment burden. These patients require intravitreal injections every 4-8 weeks in the first year of treatment.

There are also patients treated with maximum therapy that continue to have active disease and fluid.

Previous studies have found brolucizumab yields a superior resolution of sub- and intra-retinal fluid, in addition to a longer duration of action with more than 50% of eyes treated with brolucizumab 6 mg maintained on a q12 week dosing interval through 48 weeks.

In these studies, the overall safety of the study drug was similar to aflibercept.

In the ongoing multi-center retrospective study, the investigators examined 282 eyes from both treatment-naïve patients and patients who switched to brolucizumab from other anti-VEGF agents.

Overall, the majority of patients in the study were switched to brolucizumab from another VEGF medication.

The investigators calculated improvements in PED heights and summarized improvements in visual acuity.

The most common reason for the switch in medication was persistent fluid, despite regular anti-VEGF injections, followed by a desire for a treatment with a longer duration of action.

Each patient in the study received an average of 2.4 injections, with a range of 1-8 injections. Thus far, over half of the patients have discontinued brolucizumab therapy, most commonly out of caution following reports of IOI and occlusive vasculitis.

A total of 14 patients have developed an adverse event 10 of which because of IOI and 1 because of occlusive vasculitis.

For the patients receiving at least 3 injections, there were improvements seen in several measures, including the proportion of patients with no IRF, SRF, or PED, measurements of CRT and PED height, and ETDRS letter score.

“Patients with nAMD witness a high treatment burden due to frequent injections and some patients have suboptimal disease control even with frequent injections,” the authors wrote. “This study is designed to evaluate the efficacy of brolucizumab in controlling nAMD disease activity as well as decreasing treatment burden by extended treatment interval.”

Last year, the US Food and Drug Administration (FDA) approved brolucizumab for wet age-related macular degeneration, making it the first ever approved anti-VEGF to offer greater fluid resolution compared to aflibercept.

The study, “Treating Neovascular AMD patients with Brolucizumab: A Real-World Study,” was published online by ASRS 2020.