The United States Food and Drug Administration (US FDA) has approved the Vabysmo® (faricimab) 6.0 mg single-dose prefilled syringe (PFS) for treating neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). These three conditions collectively affect nearly 80 million people worldwide. The Vabysmo PFS will be available to US retina specialists and their patients in the coming months.
“We are pleased that the US FDA has approved the Vabysmo PFS for people living with neovascular age-related macular degeneration, diabetic macular edema, and retinal vein occlusion, which are some of the leading causes of vision loss,” said Levi Garraway, M.D., Ph.D., Roche’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 both physicians and patients.”
The 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.
Vabysmo is the first and only bispecific antibody approved for the eye and has demonstrated rapid and robust vision improvements and retinal drying in nAMD, DME, and RVO. Retinal drying is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.
To date, Vabysmo is approved in more than 95 countries for nAMD and DME, and in several countries, including the US and Japan, for RVO. Review by other health authorities across the globe is ongoing. More than four million doses of Vabysmo have been distributed globally since its initial US approval in 2022.
Vabysmo® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to several vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form, and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. Vabysmo is approved in more than 95 countries worldwide, including the United States, Japan, the United Kingdom, and the European Union, for people living with neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema and in several countries, including the US and Japan, for retinal vein occlusion. Review by other regulatory authorities is ongoing.
Roche in Ophthalmology
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalized healthcare, molecular engineering, biomarkers, and continuous drug delivery, we strive to design the right therapies for the right patients.
We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes gene therapies and treatments across multiple vision-threatening conditions, including diabetic eye diseases, geographic atrophy, and autoimmune conditions such as thyroid eye disease and uveitic macular edema.
Applying our extensive experience, we have already brought breakthrough ophthalmic treatments to people living with vision loss. Susvimo® (previously called Port Delivery System with ranibizumab) 100 mg/mL for intravitreal use via ocular implant was approved by the United States Food and Drug Administration in 2021. Vabysmo® (faricimab) is the first bispecific antibody approved for the eye, which targets and inhibits two signaling pathways linked to several vision-threatening retinal conditions by neutralizing angiopoietin-2 and vascular endothelial growth factor-A. Lucentis® (ranibizumab injection)* was the first treatment approved to improve vision in people with certain retinal conditions.
