Brolucizumab-dbll Approved by FDA for Wet AMD

October 8, 2019

Injection for leading cause of severe vision loss and legal blindness.

The FDA has approved brolucizumab-dbll (Beovu, Novartis) for patients suffering from Wet Age-Related Macular Degeneration (Wet AMD).

Brolucizumab-dbll is a single-chain, anti-human vascular endothelial growth factor (VEGF) inhibitor injection designed to inhibit the activation of VEGF receptors through the prevention of ligand-receptor interaction. The injection product is also designed to provide greater fluid resolution, compared to albercept, according to an official release. By inhibiting VEGFA-A, endothelial cell proliferation, neovascularization, and vascular permeability are suppressed.

The approval is based upon results of two Phase III clinical trials, HAWK and HARRIER. Over 1,800 patients across nearly 400 centers worldwide were included in the similar 96-week prospective, randomized, double-masked multi-center studies that were designed to compare the efficacy and safety of brolucizumab-dbll 6mg (HAWK and HARRIER) and 3mg (HAWK only) compared to aflibercept 2mg. 

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Results of the mean change in best-correlated visual acuity at year one (week 48) indicate that brolucizumab-dbll demonstrated at least a non-inferiority to its competing product. At least 30% of patients reported they could see 15 more letters in visual tests at year one; central subfield thickness was reduced as early as week 15 and year one; and fewer patients had intra-retinal or sub-retinal fluid, a marker of disease activity.

"BEOVU meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid," says Dr. Pravin U. Dugel, a principal investigator of the HAWK clinical trial, in a statement. "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."

Brolucizumab-dbll is contraindicated in patients with ocular or periocular infections, active intraocular inflammation, and/or a known hypersensitivity to the injection. 

Prescribing information contains warnings of potential complications following injection, including endophthalmitis and retinal detachments, an increase in intraocular pressure (within 30 minutes of injection), and arterial thromboembolic events. 

 

Adverse reactions reported with the use of brolucizumab-dbll include blurred vision, cataracts, conjunctivital hemorrhages, eye pain, and vitreous floaters. 

Full Prescribing Information