The Food and Drug Administration (FDA) has approved Vabysmo (faricimab-svoa) for the treatment of wet, or neovascular, age-related macular degeneration and diabetic macular edema.

Vabysmo is a humanized bispecific antibody that works by inhibiting the angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways. Blocking both pathways is expected to stabilize blood vessels and potentially improve vision outcomes in patients with retinal conditions. 

The approval was based on data from two phase 3 trials in patients with wet age-related macular degeneration (TENAYA [ClinicalTrials.gov Identifier: NCT03823287] and LUCERNE [ClinicalTrials.gov Identifier: NCT03823300]) and two phase 3 trials involving patients with diabetic macular edema (YOSEMITE [ClinicalTrials.gov Identifier: NCT03622580] and RHINE [ClinicalTrials.gov Identifier: NCT03622593]).

Findings from these trials demonstrated that patients treated with Vabysmo at intervals of up to 4 months achieved noninferior vision gains compared with aflibercept. The most common adverse reaction reported with Vabysmo was conjunctival hemorrhage.

Vabysmo is contraindicated in patients with active intraocular inflammation and in those with ocular or periocular infections. The product is administered via intravitreal injection, which has been associated with endophthalmitis and retinal detachments, increased intraocular pressure, and thromboembolic events.

Vabysmo is supplied as a single-dose vial containing 120mg/mL solution of faricimab-svoa for intravitreal use. Each vial should only be used for the treatment of a single eye.

“[Vabysmo] is the first bispecific antibody approved for the eye and a major advance in treating retinal conditions such as wet AMD and diabetic macular edema,” said Charles Wykoff, MD, PhD, Director of Research at Retina Consultants of Texas in Houston and a Vabysmo phase 3 investigator. “With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”

The product is expected to be available in the coming weeks.

References

  1. FDA approves Genentech’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss. News release. Genentech. January 28, 2022. Accessed January 31, 2022. https://www.businesswire.com/news/home/20220128005009/en/FDA-Approves-Genentech%E2%80%99s-Vabysmo-the-First-Bispecific-Antibody-for-the-Eye-to-Treat-Two-Leading-Causes-of-Vision-Loss.
  2. Vabysmo. Package insert. Genentech; 2021. Accessed January 31, 2022. https://www.gene.com/download/pdf/vabysmo_prescribing.pdf