FDA approves Roche’s Vabysmo prefilled syringe for eye diseases, expanding treatment options for millions

Roche (SIX: RO, ROG; OTCQX: RHHBY), a global leader in pharmaceuticals and diagnostics, announced a significant advancement in eye care with the U.S. Food and Drug Administration’s (FDA) approval of the Vabysmo (faricimab) 6.0 mg single-dose prefilled syringe (PFS). This new formulation is approved for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO)—conditions affecting nearly 80 million people worldwide.

The introduction of the Vabysmo PFS is set to enhance the administration process, offering retina specialists and patients in the United States a more convenient, ready-to-use treatment option. “We are pleased that the US FDA has approved the Vabysmo PFS for people living with these serious vision-threatening conditions,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “This new offering should make it even simpler to administer, enhancing the treatment experience for both physicians and patients.”

Roche’s Vabysmo now available in a single-dose prefilled syringe for treating eye diseases, simplifying treatment and expanding options for patients and doctors.

Vabysmo, the first bispecific antibody approved for the eye, targets and inhibits two critical pathways—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). These pathways are known to destabilize blood vessels, leading to the formation of new leaky blood vessels and increased inflammation, which are common causes of vision loss in patients with nAMD, DME, and RVO. By blocking these pathways, Vabysmo helps to stabilize blood vessels and reduce vision loss.

Since its initial U.S. approval in 2022, Vabysmo has been approved in over 95 countries for nAMD and DME, and in several, including the U.S. and Japan, for RVO. To date, more than four million doses of Vabysmo have been distributed globally, reflecting its growing acceptance and effectiveness in treating retinal diseases.

The approval of the prefilled syringe is expected to be particularly beneficial for the delivery of this medication, providing a simpler and more efficient method for healthcare professionals to administer the treatment, thus potentially improving patient outcomes.

The FDA’s approval of the Vabysmo prefilled syringe marks a notable step forward in the treatment of complex retinal conditions. This development not only simplifies the administration process but also reflects the pharmaceutical industry’s ongoing commitment to innovation and patient care in the field of ophthalmology. As more retina specialists begin to adopt this new formulation, it is anticipated that the ease of use will lead to better adherence and outcomes for patients suffering from these debilitating eye conditions.