麻豆传媒

The FDA approved the bispecific antibody faricimab-svoa (Vabysmo) for two leading causes of vision loss in adults, drugmaker .

Faricimab received marketing approval for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). The drug simultaneously targets two pathways involved in retinal disease: neutralizing angiopoietin-2 and vascular endothelial growth factor-A. The drug is administered by intravitreal injection every 1 to 4 months as compared with 1- to 2-month injection intervals for other therapies for nAMD and DME.

"Vabysmo represents an important step forward for ophthalmology," said Charles Wykoff, MD, PhD, of Retina Consultants of Texas in Houston, in a statement from the company. "With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time."

Four phase III clinical trials in nAMD and DME produced positive results to support the approval application for faricimab. Each of the studies showed that patients randomized to faricimab achieved vision gains during the first year that were noninferior to aflibercept (Eylea) with fewer injections (every 1 to 4 months versus every 2 months). The most common adverse event associated with faricimab was conjunctival hemorrhage (7% of patients).

The approval includes several dosing options. Standard treatment for nAMD consists of four monthly injections, followed by assessment of anatomical and visual, and then ongoing treatment at intervals of 2 to 4 months. Patients with DME also start with four monthly injections, followed by assessment and then ongoing treatment at 1- to 4-month intervals. Alternatively, patients with DME might begin treatment with six loading doses followed by ongoing treatment every 2 months.

Faricimab will be available in the U.S. "in the coming weeks," according to Roche.

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