FDA Approves Vabysmo (faricimab) for Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, and Macular Edema Following Retinal Vein Occlusion

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FDA Published April 14, 2026 Medically reviewed April 19, 2026 DOI ↗ By Dr. Lars van Dijk, PhD · Surgical, Procedural & Diagnostic

Key Takeaway

Consider Vabysmo for nAMD, DME, or RVO with flexible dosing based on response.

The FDA approved Vabysmo (faricimab) on January 28, 2022, for the treatment of neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). This approval provides a new therapeutic option targeting both vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2), which may address multiple pathways involved in these retinal conditions. Clinically, Vabysmo offers flexible dosing regimens, including options for extended intervals in nAMD and DME based on patient response, potentially reducing treatment burden while maintaining efficacy, though trial data is not available in the label to confirm comparative outcomes.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor.

Indication & Patient Population

VABYSMO is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD), Diabetic Macular Edema (DME), and Macular Edema Following Retinal Vein Occlusion (RVO).

Dosing & Administration

For intravitreal injection. The recommended dose is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection. For nAMD: every 4 weeks for the first 4 doses, followed by evaluations at 8 and 12 weeks to inform dosing on one of three regimens (e.g., weeks 28 and 44). For DME: two regimens: 1) every 4 weeks for at least 4 doses, with interval adjustments based on central subfield thickness and visual acuity, or 2) every 4 weeks for first 6 doses, then every 8 weeks. For RVO: every 4 weeks for 6 months. VABYSMO must be administered by a qualified physician and is available as a prefilled syringe or vial for single-eye use.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

Study Details

Study typeFda approval

PublishedJan 2022

View Original Abstract ↓

1 INDICATIONS AND USAGE VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (nAMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) Macular Edema Following Retinal Vein Occlusion (RVO) ( 1.3 ) 1.1 Neovascular (wet) Age-Related Macular Degeneration (nAMD) 1.2 Diabetic Macular Edema (DME) 1.3 Macular Edema Following Retinal Vein Occlusion (RVO)