In an adult with type 1 or type 2 diabetes and center‑involving diabetic macular edema meeting anti‑VEGF criteria, how should faricizumab (Vabysmo) be used as first‑line therapy, including dosing schedule and monitoring?

Faricimab (Vabysmo) for Center-Involving Diabetic Macular Edema

Faricimab is an FDA-approved first-line anti-VEGF agent for center-involving diabetic macular edema, dosed at 6 mg (0.05 mL) intravitreally, starting with monthly injections for at least 4 doses, then transitioning to personalized treatment intervals of up to 16 weeks based on anatomic and visual response. 1, 2

Initial Dosing Protocol

• Start with 6 mg (0.05 mL) intravitreal injections every 4 weeks (monthly) for the first 4 doses minimum 2
• This loading phase establishes disease control and allows assessment of treatment response 2
• After the initial monthly dosing period, transition to interval extension based on clinical response 2

Personalized Treatment Interval (PTI) Extension

• After initial monthly dosing, extend treatment intervals based on anatomic (OCT) and visual stability 3
• Approximately 78% of patients can achieve 12-week intervals and 63% can reach 16-week intervals by week 96 3
• The dual mechanism (blocking both VEGF-A and angiopoietin-2) provides superior durability compared to traditional anti-VEGF monotherapy 4
• Monitor monthly with OCT during interval extension to determine optimal re-treatment timing 1, 2

Monitoring Schedule

• Follow-up visits every 1-3 months during active treatment phase 1
• At each visit, assess:
  • Best-corrected visual acuity (BCVA) 4
  • Central subfield thickness on OCT 4
  • Presence of intraretinal or subretinal fluid 2
  • Diabetic retinopathy severity (DRSS score when applicable) 4
• Once stable on extended intervals (12-16 weeks), continue monitoring at each injection visit 2

Clinical Advantages Over Other Anti-VEGF Agents

• Faricimab demonstrated statistically superior visual acuity gains (3.6 letters) versus ranibizumab in treatment-naïve patients 4
• Significantly longer treatment intervals reduce patient burden compared to aflibercept or ranibizumab, which typically require every 4-8 week dosing in the first year 1, 3
• Real-world data shows 61-81% of treatment-naïve eyes achieve extended intervals 5
• Comparable safety profile to other anti-VEGF agents with no new safety signals 4

Special Considerations and Caveats

• For eyes with moderate visual impairment (20/50 or worse), aflibercept has demonstrated superior outcomes to bevacizumab, but faricimab offers comparable efficacy with better durability 1, 4
• Eyes previously treated with subtenon triamcinolone or those with disorganization of retinal inner layers may be less likely to achieve 12-week intervals 6
• If persistent DME occurs despite faricimab, consider adding macular laser photocoagulation or switching to intravitreal corticosteroids 1
• Maintain systemic glycemic control as adjunct therapy—this remains critical alongside intravitreal treatment 2

When Faricimab May Not Be First-Line

• Pregnancy: Use macular laser photocoagulation or intravitreal corticosteroids instead 1
• Eyes with good vision (20/25 or better) despite center-involving DME: Close monitoring with deferred treatment provides similar 2-year outcomes to immediate anti-VEGF therapy 1
• In low-resource settings where cost is prohibitive, consider bevacizumab off-label or focal laser as alternatives 1

Common Pitfall to Avoid

Do not continue rigid monthly dosing beyond the initial loading phase—faricimab's dual mechanism allows for significant interval extension in most patients, and failure to extend intervals unnecessarily increases treatment burden and cost without additional benefit 3, 5