The U.S. Food and Drug Administration has approved Genentech's Vabysmo  (faricimab-svoa) 6.0 mg single-dose prefilled syringe for the treatment of wet or neovascular age-related macular degeneration, diabetic macular edema, and macular edema following retinal vein occlusion.

The approval is based on the prefilled syringe’s (PFS) demonstrated vision improvements and retinal drying in wet or neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO), according to a recent press release. Retinal drying is important because swelling from excess fluid in the back of the eye leads to distorted and blurred vision.

Vabysmo targets and inhibits two signaling pathways by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A VEGF-A). “While research is underway to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are thought to contribute to vision loss by destabilizing blood vessels, which may cause new leaky blood vessels to form and increase inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels,” the press release noted.

The PFS delivers the same medicine as the existing Vabysmo vials in a prefilled syringe format. It will be available to U.S. retina specialists in the coming months. Vabysmo continues to be available in a 6.0 mg vial.