FDA approval for new anti-VEGF drug

Novartis’ brolucizumab (Beovu) has received FDA approval for the treatment of wet AMD, with the company claiming it is the first approved anti-VEGF drug to outperform aflibercept on fluid resolution, while offering similar vision gains on a three-month dosing schedule.

Phase 3 HAWK and HARRIER trials demonstrated the feasibility of extended dosing after three monthly loading doses. Compared with aflibercept, brolucizumab-treated patients showed greater reduction in central subfield thickness as early as week 16 and at year one. While fewer patients had intraretinal or subretinal fluid, said Anni Delfaro from Novartis.

“With Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas,” said HAWK trial lead, Professor Pravin Dugel of the Roski Eye Institute in Los Angeles. “Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD.”

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