FDA approves Genentech’s Vabysmo prefilled syringe for eye diseases

In a significant advancement in the treatment of eye diseases, the U.S. Food and Drug Administration (FDA) has approved Genentech‘s Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). This approval marks a pivotal development for nearly three million Americans affected by these conditions.

The new Vabysmo PFS is set to revolutionize the administration of treatment for retina specialists and their patients by simplifying the process. “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,” stated Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. The prefilled syringe is designed to make the administration process more straightforward, enhancing both the treatment experience and adherence.

Vabysmo, the first and only bispecific antibody for the eye, targets two critical pathways involved in several vision-threatening retinal conditions. By neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), Vabysmo helps to stabilize blood vessels, thereby reducing the risk of new leaky blood vessels and inflammation.

Since its initial approval in the U.S. in 2022, Vabysmo has been approved in over 95 countries for wet AMD and DME and several countries for RVO. This widespread approval underscores the global recognition of Vabysmo’s efficacy. More than four million doses of Vabysmo have been distributed worldwide, highlighting its acceptance and the high demand for effective treatments in ocular health.

The introduction of the Vabysmo prefilled syringe is a significant leap forward in retinal treatment. This innovation not only provides a more convenient treatment modality but also promises enhanced safety and efficacy in combating major causes of vision loss. The continued global approval of Vabysmo reflects its potential to set a new standard in the treatment of retinal diseases.