What is the purpose of Vabysmo (faricimab-svoa)?

Vabysmo (faricimab-svoa) is a medication that serves as a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor. It is meant for the treatment of neovascular (“wet”) age-related macular degeneration (nAMD) and diabetic macular edema (DME). The formula is available in a single-dose vial, containing 120 mg/mL faricimab-svoa.

How does Vabysmo (faricimab-svoa) work?

The proteins Ang-2 and VEGF-A generally contribute to the formation of vision-threatening neovascular degeneration in diseases like nAMD and DME. Faricimab-svoa, the active ingredient in Vabysmo, is a bispecific antibody that binds and blocks pathways linked to Ang-2 and VEGF-A. This stabilizes blood vessels, reduces inflammation, and helps maintain proper vision.

Where is Vabysmo (faricimab-svoa) approved?

Vabysmo (faricimab-svoa) received approval from the FDA on January 28, 2021, for the treatment of nAMD and DME. This medication may also have been approved in other regions aside from the ones mentioned.

What are the standard dosage instructions for Vabysmo (faricimab-svoa)?

The standard dosage for Vabysmo is an injection of 6mg into the eye every four weeks for the first four doses, with additional courses scheduled according to clinical evaluation assessments. It is not suitable for use during pregnancy unless the expected advantages outweigh the risks.

Are there any known adverse reactions or side effects with Vabysmo (faricimab-svoa)?

The most prevalent side effects (in more than 5% of patients) include conjunctival hemorrhage. Serious side effects, like hypersensitivity and endophthalmitis and retinal detachments, were also found. The official prescribing information provides a comprehensive list of all potential side effects and adverse reactions. Consult with your doctor for personalized dosing information.

Clinical trials

The approval of Vabysmo (faricimab-svoa) by the FDA for neovascular or “wet” age-related macular degeneration (nAMD) was based on data from the TENAYA (NCT03823287) and LUCERNE (NCT03823300) phase 3 studies. The studies involved 1,329 patients with nAMD who received either Vabysmo or aflibercept. Both studies achieved their primary endpoints, with the vision gains seen in patients treated with Vabysmo being non-inferior to aflibercept-treated patients.

For diabetic macular edema (DME), the FDA approval of Vabysmo was based on data from the YOSEMITE (NCT03622580) and RHINE (NCT03622593) phase 3 studies involving 1,891 people. The patients received either Vabysmo or aflibercept, and both studies achieved their primary endpoints. The vision gains seen in patients treated with Vabysmo were non-inferior to those of aflibercept-treated patients.

Comprehensive information about the safety and effectiveness of Vabysmo for the approved indication can be found in the summary of product characteristics in the resource section.