faricimab for treating visual impairment due to diabetic macular oedema

Last edited 07/2022 and last reviewed 08/2022

Faricimab for treating visual impairment due to diabetic macular oedema

Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has been first line in treating neovascular age-related macular degeneration (nAMD)

• however, patients require frequent anti-VEGF injections to maintain visual outcomes (1)
• in randomized clinical trials (RCTs) evaluating anti-VEGF injections in nAMD, approximately 68% of patients do not achieve the threshold for driving vision (best-corrected visual acuity [BCVA] of 20/40 Snellen equivalent) after 1 year of treatment (2)
• in addition, suboptimal dosing frequency in clinical practice is correlated with loss of vision over time, with many patients not achieving and maintaining visual outcomes observed in clinical trials (2)

Faricimab

• neutralizes angiopoietin-2 and vascular endothelial growth factor A via both simultaneous and independent binding
• bispecific antibody designed for intraocular use
• simultaneously and independently binds and neutralizes angiopoietin (Ang)-2 and VEGF-A with high specificity and potency
  • Ang-1/tyrosine kinase with immunoglobulinlike domains 2 signaling maintains stable vasculature and homeostasis;
  • Ang-2 blocks Ang-1-mediated activation of tyrosine kinase with immunoglobulinlike domains 2, causing inflammation and vascular destabilization, including leakage and neovascularization.
  • simultaneous Ang-2 and VEGF neutralization has additive benefits in preclinical models of choroidal neovascularization (CNV) (1)
  • study evidence showed that (1):
    • att week 52, faricimab dosing every 16 weeks and every 12 weeks resulted in maintenance of initial vision and anatomic improvements comparable with monthly ranibizumab
    • results suggest a role for simultaneous neutralization of angiopoietin-2 and vascular endothelial growth factor A in providing sustained efficacy through extended durability

NICE state:

• Faricimab is recommended as an option for treating visual impairment due to diabetic macular oedema in adults, only if:

  • the eye has a central retinal thickness of 400 micrometres or more at the start of treatment

  • the company provides faricimab according to the commercial arrangement

Reference:

• Khanani AM et al. Efficacy of Every Four Monthly and Quarterly Dosing of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The STAIRWAY Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):964-972. doi: 10.1001/jamaophthalmol.2020.2699. Erratum in: JAMA Ophthalmol. 2020 Sep 1;138(9):1006. PMID: 32729897; PMCID: PMC7489851
• Sahni J et al. Safety and Efficacy of Different Doses and Regimens of Faricimab vs Ranibizumab in Neovascular Age-Related Macular Degeneration: The AVENUE Phase 2 Randomized Clinical Trial. JAMA Ophthalmol. 2020 Sep 1;138(9):955-963. doi: 10.1001/jamaophthalmol.2020.2685. PMID: 32729888; PMCID: PMC7393587
• NICE (July 2022). Faricimab for treating diabetic macular oedema