Welcome to our latest edition of the Guidelines+ Monographs Series, where we delve into the medication faricimab-svoa, marketed under the brand name Vabysmo® by Genentech. Vabysmo is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). It was initially approved in 2022.
In the following sections, we will provide a comprehensive overview of faricimab-svoa and analyze its positioning across various guidelines for its approved indications.
Note* - This Guidelines+ Monographs for faricimab-svoa (Vabysmo) is current as of February 2025. Consult our clinical guidelines library and/or or medication information look up tool to ensure you are always accessing the most current information.
Without further delay, let’s jump in!
Medication Overview:
- Brand name: Vabysmo
- Generic name: faricimab-svoa
- Manufacturer(s): Genentech
- Initial FDA Approval: January 2022
Indications and FDA Approval Details
| Indicated Condition | Indicated | Age Range | Date Approved |
|---|---|---|---|
| Neovascular (Wet) Age-Related Macular Degeneration (nAMD) | for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (nAMD). | Adults | January 28, 2022 |
Diabetic Macular Edema (DME) | for the treatment Diabetic Macular Edema (DME). | Adults | January 28, 2022 |
| Macular Edema Following Retinal Vein Occlusion (RVO) | for the treatment of Macular Edema Following Retinal Vein Occlusion (RVO). | Adults | October 26, 2023 |
Dosage and Administration
For intravitreal injection.
- Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
- The recommended dose for VABYSMO is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for the first 4 doses, followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to inform whether to give a 6 mg dose via intravitreal injection on one of the following three regimens: 1) Weeks 28 and 44; 2) Weeks 24, 36 and 48; or 3) Weeks 20, 28, 36 and 44. Although additional efficacy was not demonstrated in most patients when VABYSMO was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.
- Diabetic Macular Edema (DME)
- VABYSMO is recommended to be dosed by following one of these two dose regimens: 1) 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days ± 7 days, monthly) for at least 4 doses. If after at least 4 doses, resolution of edema based on the central subfield thickness (CST) of the macula as measured by optical coherence tomography is achieved, then the interval of dosing may be modified by extensions of up to 4 week interval increments or reductions of up to 8 week interval increments based on CST and visual acuity evaluations; or 2) 6 mg dose of VABYSMO can be administered every 4 weeks for the first 6 doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks (2 months). Although additional efficacy was not demonstrated in most patients when VABYSMO was dosed every 4 weeks compared to every 8 weeks, some patients may need every 4 week (monthly) dosing after the first 4 doses. Patients should be assessed regularly.
- Macular Edema Following Retinal Vein Occlusion (RVO)
- The recommended dose for VABYSMO is 6 mg (0.05 mL of 120 mg/mL) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days, monthly) for 6 months.
Dosage Forms and Strengths
Injection: 6 mg (0.05 mL of 120 mg/mL solution) in a single-dose prefilled syringe
- Injection: 6 mg (0.05 mL of 120 mg/mL solution) in a single-dose vial
Contraindications
- Ocular or periocular infection
- Active intraocular inflammation
- Hypersensitivity
Warnings and Precautions
- Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.
- Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
- There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition.
Adverse Reactions
The most common adverse reactions (≥ 5%) reported in patients receiving VABYSMO were cataract (15%) and conjunctival hemorrhage (8%).
Now that we’ve covered the basic monograph information for Vabysmo, let’s take a closer look at how it is currently recommended in various clinical practice guidelines.
Specific Inclusions of Faricimab-svoa in the Guidelines
- Diabetes Standards of Care 2025
- Authoring Society: American Diabetes Association (ADA)
- Publication: December 09, 2024
The ADA’s Diabetes Standards of Care (2025) includes faricimab-svoa within the below recommendations:
- Anti-VEGF injections are recommended as a reasonable alternative to traditional panretinal laser photocoagulation for some individuals with PDR and also to reduce the risk of vision loss. (Grade A)
- Anti-VEGF injections are recommended as first-line treatment for most eyes with diabetic macular edema that involves the foveal center and impairs vision acuity. (Grade A)
Since the approval of faricimab-svoa in 2022, it has only been featured in one guideline. However, we anticipate its inclusion in future updates from multiple societies going forward.
This concludes our Guidelines+ Monographs for faricimab-svoa (Vabysmo). This list is current as of February 2025, and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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