A recently published analysis found that brolucizumab (Beovu) controlled neovascular macular degeneration (nAMD) better than aflibercept (Eyelea) in two clinical trials.
“Together, the functional and anatomical [disease activity] evaluations in [the two trials] indicate that nAMD patients treated with [brolucizumab] 6mg q12w/q8w have lower risk of DA occurrence than [aflibercept] and thereby better disease control,” the analysis says.
The analysis analyzed the results of two clinical trials, named HAWK and HARRIER. 358 patients were given 3mg doses of Beovu, 360 patients were given 6mg doses of Beovu and 360 patients were given 2mg doses of Eyelea in the HAWK trial. 370 patients were given 6mg doses of Beovu and 369 patients were given 2mg doses of Eyelea in the HARRIER trial. Disease activity was assessed at weeks 16, 20, 32, 44, 56, 68, 80 and 92 in both trials with additional assessment at weeks 28, 40, 52, 64, 76 and 88 in the HARRIER trial. Beovu patients were dosed on a 12-week interval unless disease activity was present, at which point they were dosed on an 8-week interval. Eyelea patients were dosed on an 8-week interval.
28.1% of patients given 3mg Beovu, 24% of patients given 6mg Beovu and 34.5% of patients given Eyelea had disease activity at week 16 in the HAWK trial. 22.7% of Beovu patients and 32.2% of Eyelea patients had disease activity at week 16 in the HARRIER trial. The researchers also found that disease activity was more prevalent in Eyelea patients than Beovu patients across all disease activity assessments.
Eyelea is considered standard of care for nAMD.
Beovu is a wet AMD drug. New blood vessels grow in the choroid layer behind the retina in wet AMD. These new blood vessels are weak and, because they are weak, they leak blood, lipids and fluid. Scar tissue formation can result from this leaking. The leaking can also cause retinal cells to stop working.
The American Society of Retina Specialists recently sent a note to their members warning that they knew of 11 cases of occlusive retinal vasculitis in patients taking Beovu. Occlusive retinal vasculitis can cause loss of vision. Novartis later acknowledged that severe vision loss, vasculitis or retinal artery occlusion occurred in up to 10.08 out of 10,000 injections of Beovu during a one month period. Novartis said it will work with the FDA and other regulators to update the product label of Beovu and change the protocols of clinical trials to prevent adverse events.