NEW YORK (Reuters Health) – Patients with recalcitrant neovascular age-related macular degeneration (nAMD) who switched to brolucizumab from another anti-VEGF agent showed signs of improved vision in a single-center, retrospective study.
The study also found a small risk of serious, but treatable, side effects with the drug, corroborating the existing data on brolucizumab from randomized controlled trials.
“The intraocular inflammation is pretty much in line with what we’ve seen in the HAWK and HARRIER trials,” Dr. Michael Singer, a clinical professor of ophthalmology at the University of Texas Health Science Center in San Antonio, told Reuters Health by phone.
“You’ve got a percentage of patients with intraocular inflammation, the majority of the inflammation actually resolves,” said Dr. Singer, who was not involved in the study. He added that there was “a small minority with significant side effects, like vascular occlusion or retinal vasculitis.”
Brolucizumab, sold under the brand name Beovu, was recently approved in the U.S. and Europe to treat nAMD.
The new study, published in the British Journal of Ophthalmology, looked at real-world outcomes in 57 patients with recalcitrant nAMD who were treated with the drug at the University of Bonn in Germany. About half were women, and their mean age was 80 years.
Every patient had been previously treated with anti-VEGF treatments such as ranibizumab, aflibercept or bevacizumab due to evidence of recalcitrant fluid accumulations within their eyes as identified by optical coherence tomography. These patients were switched to brolucizumab, with their first day of intravitreal brolucizumab injection set as their baseline visit.
Over the course of eight months in 2020, 63 individual eyes were treated with at least one brolucizumab injection and were assessed upon their first return visit after a mean of 4.3 weeks. Cumulatively, 207 brolucizumab injections were administered, with a mean of 3.09 injections per eye, report Dr. Frank Holz of the University of Bonn and colleagues.
The authors examined four functional and physiological results: best-corrected visual acuity (BCVA), foveal centre point (FCP), central subfield retinal thickness (CSRT) and macular volume.
The mean visual acuity change for BCVA was -0.03 logMAR (P=0.115). FCP was reduced by 66.81 um, CSRT by 66.76 um and macular volume by 0.27 mm3 (P<0.001 for each).
Seven eyes (11%) in seven patients (3% per 207 given injections) developed some form of intraocular inflammation, including in one instance a case of retinal vasculitis without occlusion. Each case was believed to be drug related.
Within this small group, anterior uveitis with anterior chamber cells was noted in only two patients. Four eyes had additional signs of intermediate uveitis occurring in anterior and vitreous cells.
Dr. Singer pointed out that treatment-switching studies like this one are most often working with patients who suffer from the most severe disease.
“The difference with brolucizumab, when you get to switch studies,” he said, “is that by the time they get to the point that they’re being tried, these eyes have probably lost a good amount of photoreceptors and their potential for visual improvement is almost nothing.”
Dr. Holz and colleagues note that “further long-term analyses appear prudent to assess efficacy and safety of brolucizumab,” a point with which retina specialist Dr. Ashish Sharma of the Lotus Eye Hospital and Institute in Coimbatore, India, agrees.
“Most of the further research regarding brolucizumab usage should be focused on identifying at-risk populations,” Dr. Sharma, who was not involved in the study, told Reuters Health by email. He noted that the cases reported so far include a preponderance of female patients and many cases with associated systemic conditions.
“A thorough meta-analysis of all cases with additional data points such as levels of anti-drug antibodies (ADA) should be done,” he said.
The study had no specific funding. Two of the authors report ties to Novartis, which sells brolucizumab.
SOURCE: https://bit.ly/3fgDznY The British of Journal Opthamology, online May 11, 2021.
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