FDA Approves Beovu for Treatment of Wet Age-Related Macular Degeneration

The Food and Drug Administration (FDA) has approved Beovu (brolucizumab-dbll; Novartis) injection, also referred to as RTH258, for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Beovu is a human vascular endothelial growth factor (VEGF) inhibitor that binds to 3 major isoforms of VEGF-A preventing endothelial cell proliferation, neovascularization, and vascular permeability. Beovu is administered via intravitreal injection as 6mg monthly for the first 3 doses, followed by 6mg once every 8-12 weeks.

The approval was based on data from two phase 3, prospective, double-masked, multicenter studies (HAWK and HARRIER) that compared the efficacy and safety of Beovu to aflibercept in 1817 patients with neovascular AMD for 96-weeks. In the HAWK study, patients were randomized 1:1:1 to receive Beovu 3mg or 6mg every 8 or 12 weeks, or aflibercept 2mg every 8 weeks after the first 3 monthly doses. In the HARRIER study, patients were randomized 1:1 ratio to receive Beovu 6mg every 8 or 12 weeks, or aflibercept 2mg every 8 weeks after the first 3 monthly doses. 

Findings from both studies demonstrated Beovu to be non-inferior compared with aflibercept in meeting the primary end point, defined as the mean change from baseline in Best Corrected Visual Acuity (BCVA) at Week 48 (least squares [LS] mean, +6.6 [6 mg] and +6.1 [3 mg] letters with Beovu vs +6.8 letters with aflibercept [HAWK]; +6.9 [Beovu 6 mg] vs +7.6 [aflibercept] letters [HARRIER]; P < 0.001 for each comparison). Both studies also showed approximately 30% of Beovu-treated patients gained at least 15 letters at Week 48.

Additionally, a statistically significant greater reduction in central subfield thickness (secondary end point) was observed with Beovu by Week 48 in HAWK (LS mean −172.8 μm vs −143.7 μm; P =.001) and HARRIER (LS mean −193.8 μm vs −143.9 μm; P <.001). Fewer patients experienced intra-retinal (IRF) and/or sub-retinal fluid (SRF) with Beovu as well. Through Week 48, 56% and 51% of patients were maintained on the 12-week dosing regimen in the HAWK and HARRIER studies, respectively.

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Regarding safety, the most common adverse events for Beovu were vision blurred, cataract, conjunctival hemorrhage, vitreous floaters and eye pain. Beovu is contraindicated for use in patients with active intraocular inflammation, ocular or periocular infections, or with known hypersensitivity to brolucizumab.

“Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid,” said Dr. Pravin U. 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.”

Beovu injection is supplied as a 6mg/0.05mL solution in a single-dose vial.

For more information visit novartis.com.