INTRAVITREAL FARICIMAB (VABYSMO) IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (NAMD) AND DIABETIC MACULAR EDEMA (DME): STRUCTURED EVIDENCE REVIEW

Background: Anti-VEGF intravitreal therapy has transformed the treatment of neovascular age-related macular degeneration and diabetic macular edema; however, issues like treatment burden and incomplete anatomic responses persist. Faricimab (Vabysmo) is a humanized bispecific antibody that inhibits both VEGF-A and stabilizes vessels, addressing these challenges through its dual action. Objective: To assess the effectiveness, durability, safety, pharmacodynamics and feasibility of intravitreal faricimab in adults with nAMD or DME. Methods: Structured literature search was performed, using peer-reviewed pivotal randomized trials, two-year follow-up studies, pharmacodynamic studies, regulatory prescribing information, systematic reviews/network meta-analyses, trial registries and real-world observational evidence. The core evidence base included the TENAYA/LUCERNE trials in nAMD, the YOSEMITE/RHINE trials in DME, and some comparative and real-life studies. This is a structured evidence synthesis and not a prospective, registered systematic review, because it lacked duplicate, independent screening and a new quantitative meta-analysis. Results: At one year, faricimab showed non-inferior visual outcomes compared to aflibercept for treatment-naïve nAMD, with sustained results at two years. A significant percentage of patients achieved Q16W dosing by week 112. There were no notable differences between fixed DME Q8W and personalized DME T&E faricimab regimens in visual outcomes one year post-treatment. Faricimab demonstrated similar visual outcomes with fewer injections and favored anatomic results for two-year DME when compared to aflibercept. Safety profiles were similar; however, specific risks such as intraocular inflammation and arterial thromboembolic events require monitoring. Real-world data indicate that visual improvements may be less durable in previously treated nAMD eyes. Conclusions: Faricimab demonstrates effective visual outcomes, strong anatomical control, and a prolonged dosing schedule in treating nAMD and DME. However, its primary benefit is not necessarily a consistent improvement in visual acuity. Analysis must consider trial populations, aflibercept Q8W comparator treatments, sponsor involvement in pivotal trials, and the absence of long-term independent comparative data.