FARICIMAB-SVOA INJ,SOLN
Clinical Criteria Summary
Indications & Patient Population
- Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
- Diabetic Macular Edema (DME)
- Bispecific antibody acting through inhibition of vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2)
Dosing Regimens & Administration
- Form: Intravitreal injection, 120 mg/mL solution in a single-dose vial
- nAMD: 6 mg (0.05 mL) administered by intravitreal injection every 4 weeks (approximately every 28 ± 7 days) for the first 4 doses
- DME: 6 mg administered by intravitreal injection either every 4 weeks for at least 4 doses, or every 4 weeks for the first 6 doses followed by every 8 weeks over the next 28 weeks
- Some patients may require every 4-week (monthly) dosing after the initial loading doses
Monitoring & Assessment Requirements
- Optical coherence tomography (OCT) and visual acuity (VA) evaluations at 8 and 12 weeks following the first 4 doses to inform subsequent dosing intervals
- Central subfield thickness (CST) of the macula as measured by OCT for DME dosing interval modifications (extensions up to 4-week increments or reductions up to 8-week increments based on CST and VA evaluations through week 52)
- Regular assessment of patients throughout treatment
Contraindications & Safety Considerations
- Ocular or periocular infection
- Active intraocular inflammation
- Hypersensitivity to faricimab or excipients
- Risk of endophthalmitis and retinal detachments following intravitreal injections; patients must be instructed to report suggestive symptoms without delay
- Increases in intraocular pressure may occur within 60 minutes of an intravitreal injection
- Potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition
- Potential for immunogenicity (anti-faricimab antibodies detected in approximately 10.4% of nAMD and 8.4% of DME patients post-initiation)
Place in Therapy / Specific Use Criteria
- Demonstrated non-inferiority to aflibercept administered every 8 weeks for both nAMD and DME
- Approximately 75% of patients with nAMD or DME can be maintained on dosing intervals of every 12 or 16 weeks while maintaining comparable visual gains and CST reduction
- Particularly useful for patients who would benefit from reducing treatment burden (e.g., long travel times, physical mobility limitations)