Novartis’ brolucizumab (Beovu) is now FDA-approved for the treatment of wet AMD, the company reported today. Brolucizumab is the first approved anti-VEGF drug to outperform aflibercept on fluid resolution while offering similar vision gains on a 3-month dosing regimen.
The approval is based on the phase 3 HAWK and HARRIER trials, which demonstrated the feasibility of extended dosing after 3 monthly loading doses. By year 1, more than half of the trial’s participants were maintained on a 3-month dosing interval, while the others received a 2-month dosing schedule.
“The product labels of existing treatments state that they are not as effective when dosed every 12 weeks. Beovu is the first to offer less frequent dosing in the first year of therapy while maintaining its effectiveness,” says Marie-France Tschudin, President, Novartis Pharmaceuticals. “This gives more time for wet AMD patients to focus on what’s important in their lives.”
In both clinical trials, about 30% of patients gained at least 15 letters by year 1. Compared with aflibercept, brolucizumab-treated patients showed greater reduction in central subfield thickness as early as week 16 and at year 1, and fewer patients had intraretinal or subretinal fluid. The overall safety profile was comparable to aflibercept; common adverse events includes blurred vision, cataract, conjunctival hemorrhage, vitreous floaters and eye pain.
“With Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas,” said Pravin U. Dugel, MD, clinical professor at the Roski Eye Institute and principal investigator of the HAWK clinical trial. “Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD.”
According to Reuters, brolucizumab is expected to cost $11,100 for the first year, and $7,400 each year thereafter for patients on 3-month dosing intervals—prices that are comparable to aflibercept.