Faricimab for Center-Involving Diabetic Macular Edema
Faricimab can be used as first-line therapy for center-involving diabetic macular edema, as it is now recognized alongside bevacizumab, ranibizumab, aflibercept, and brolucizumab as a standard anti-VEGF treatment option. 1
First-Line Use
The American Diabetes Association's 2025 guidelines explicitly acknowledge faricimab as one of five anti-VEGF agents currently used for center-involved DME, placing it on equal footing with established agents like ranibizumab and aflibercept. 1
Anti-VEGF therapy is the established standard of care for center-involving DME in high-resource settings, demonstrating superior outcomes compared to laser photocoagulation alone. 2
Intravitreal anti-VEGF injections are indicated for central-involved diabetic macular edema that occurs beneath the foveal center and threatens reading vision. 2
Loading Dose Regimen
The recommended loading regimen for faricimab is 4 monthly injections (every 4 weeks) based on the YOSEMITE and RHINE phase 3 trial design. 3
This differs from the traditional 6-8 injection loading phase used with older anti-VEGF agents. 2
The 4-dose monthly loading phase was specifically designed for faricimab's dual mechanism targeting both VEGF-A and angiopoietin-2. 3
Treat-and-Extend Dosing Schedule
After the initial 4 monthly loading doses, faricimab should be administered using a personalized treatment interval (PTI) approach that allows extension up to every 16 weeks based on objective disease activity criteria. 3
PTI Protocol Details:
The PTI regimen is based on the treat-and-extend concept with protocol-defined, objective criteria for interval adjustment—not arbitrary investigator discretion. 3
Treatment intervals can be extended up to every 16 weeks (4 months), which represents a significant advantage over traditional monthly or 8-week dosing schedules. 3
Interval adjustments are based on standardized anatomic (OCT central subfield thickness) and functional (visual acuity) outcomes. 3
When to Maintain or Shorten Intervals:
Continue monthly dosing until vision and edema are no longer improving or can no longer improve (e.g., vision 20/20 or better, or edema resolved). 2
If edema recurs or worsens at any follow-up visit, return to more frequent dosing intervals (typically every 4 weeks) until stability is re-established. 2
Monitor with OCT at each visit to assess for recurrence, defined as OCT central subfield thickness ≥250 μm or clinically significant edema within 500 μm of the macular center. 2
Clinical Efficacy Evidence
In the phase 2 BOULEVARD trial, faricimab 6.0 mg demonstrated statistically superior visual acuity gains versus ranibizumab (13.9 vs 10.3 ETDRS letters, p=0.03) in treatment-naïve patients. 4
Faricimab showed dose-dependent reductions in central subfield thickness, improvements in diabetic retinopathy severity scale scores, and longer time to re-treatment during observation periods compared with ranibizumab. 4
Real-world data demonstrates significant CST reduction across all patient groups, including treatment-naïve and previously-treated patients, with mean CST decreasing from 465.8 μm to 343.1 μm (p<0.0001) in treatment-naïve DME patients. 5
Important Clinical Considerations
Adjunctive Laser Therapy:
Defer focal/grid laser for at least 24 weeks after initiating faricimab, as anti-VEGF monotherapy is superior to combination therapy. 2
Add laser only if edema persists after 24 weeks with no improvement from two consecutive injections. 2
Switching from Other Anti-VEGF Agents:
Faricimab may extend treatment intervals in patients with DME refractory to ranibizumab or aflibercept, with mean recurrence intervals extending from 5.8 weeks to 10.8 weeks (p=0.0005). 6
However, eyes previously treated with subtenon triamcinolone or those with disorganization of retinal inner layers may be less likely to achieve extended intervals ≥12 weeks. 6
Safety Profile:
Faricimab showed no new or unexpected safety signals in clinical trials. 4
No serious adverse events were reported in real-world studies of DME patients. 6, 7