Novartis has received FDA approval for its Beovu (brolucizumab) injection for the treatment of wet age-related macular degeneration (AMD), on the back of results from the Phase III HAWK and HARRIER clinical trials where Beovu demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity at year one. In both trials Beovu showed greater reduction in central subfield thickness by week 16 and at year 1, and fewer patients had intra-retinal and/or sub-retinal fluid. Patients were maintained on a three-month dosing interval immediately after the loading phase, and at year 1, 56% of patients in HAWK and 51% of patients in HARRIER were maintained on the three-month dosing interval, with the rest of the patients being treated on a two-month dosing schedule. Beovu’s overall safety profile was similar to aflibercept.
Marie-France Tschudin, Novartis Pharmaceuticals’ president, said: “The approval of Beovu delivers on the Novartis commitment to reimagining treatments for patients suffering from serious visual impairment. 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. This gives more time for wet AMD patients to focus on what’s important in their lives.”
“FDA approves Novartis’ Beovu for wet AMD“
Dr. Pravin U. Dugel, Managing Partner, Retinal Consultants of Arizona, Clinical Professor at Roski Eye Institute, Keck School of Medicine, and principal investigator of the HAWK clinical trial, said: “Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid. 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.”