SAN FRANCISCO, Calif.—Genentech, a biotechnology company that specializes in the treatment of eye diseases that cause visual impairment, (SIX: RO, ROG; OTCQX: RHHBY) has announced it received approval from the U.S. Food and Drug Administration (FDA) for Vabysmo (faricimab-svoa), a 6.0 mg single-dose pre-filled syringe (PFS) for use in the treatment of wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME) and macular edema following retinal vein occlusion (RVO). The company, a member of the Roche Group, noted these three conditions affect close to 3 million people in the U.S. The Vabysmo PFS will become available to U.S. retina specialists and their patients in the coming months.

“We are pleased that the U.S. FDA has approved the Vabysmo PFS for people living with wet AMD, DME and RVO, which are some of the leading causes of vision loss,” said Dr. Levi Garraway, Genentech’s chief medical officer and head of global product development. “While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for physicians and patients.”

Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials in an alternative, ready-to-use format. Vabysmo will continue to be available in a 6.0 mg vial, Genentech said.

Genentech stated that Vabysmo is the first and only bispecific antibody approved for the eye, and has demonstrated rapid and robust vision improvements and retinal drying in wet AMD, DME and RVO. The company added that retinal drying is an important clinical measure, because swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.

Vabysmo has been approved in more than 95 countries for wet AMD and DME, and in several countries, including the U.S. and Japan, for RVO. Review by other health authorities across the globe is ongoing. More than 4 million doses of Vabysmo have been distributed globally since its initial U.S. approval in 2022, according to the announcement.

More information about Vabysmo is available at or