Novartis gets FDA nod for new eye drug Beovu

With its leading ophthalmology drug Lucentis (ranibizumab) nearing the end of its patent exclusivity, there was good news for Swiss pharma giant Novartis (NOVN: VX) with US regulatory approval for its successor.

The US Food and Drug Administration approved Beovu (brolucizumab) injection, also known as RTH258 for the treatment of wet age-related macular degeneration (AMD).

Beovu is the first FDA-approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy, says Novartis.

“Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid,” said Dr Pravin Dugel, managing partner, Retinal Consultants of Arizona; Clinical Professor, Roski Eye Institute, Keck School of Medicine, University of Southern California; and principal investigator of the HAWK clinical trial. “With Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas. Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD,” he noted.