1. Faricimab every 8 weeks and faricimab per personalized treatment interval (PTI) were noninferior to aflibercept for mean change in visual acuity.
2. Adverse events between faricimab every 8 weeks, faricimab PTI, and aflibercept every 8 weeks were comparable.
Evidence Rating Level: 1 (Excellent)
Study Rundown: First-line treatment for diabetic macular edema (DME) includes anti-vascular endothelial growth factor (VEGF) medications such as aflibercept. However, this treatment involves close monitoring with regular injections every 4-8 weeks. Faricimab is an angiopoietin-2 and VEGF bispecific antibody that may be used in the management of patients with DME, although little is known at this time. This study is an amalgamation of two randomized, double-masked, phase 3 trials (YOSEMITE and RHINE) that were conducted to assess the safety and efficacy of faricimab in patients with DME. The primary outcome was mean change in best-corrected visual acuity (BCVA) from baseline to 52 weeks while key secondary outcome included the proportion of patients receiving faricimab at regular 4-week intervals. According to study results, faricimab every eight weeks and faricimab per personalized treatment interval (PTI) were non-inferior to aflibercept every weight weeks for visual acuity at 52 weeks. This study was strengthened by pooling of results from two separate randomized controlled trials.
Click to read the study in The Lancet
In-depth [randomized-controlled trial]: Between Sept 5, 2018, and Sept 19, 2019 (YOSEMITE) and Oct 9, 2018, and Sept 20, 2019 (RHINE), 3247 patients were screened for eligibility across 353 sites worldwide. Included were those ≥18 years of age with center-involving diabetic macular edema. Altogether, 1891 patients (940 in YOSEMITE and 951 in RHINE) were included in the intention-to-treat analysis (632 to faricimab every 8 weeks, 632 to faricimab PTI, and 627 to aflibercept every 8 weeks). Regarding the primary outcome of mean change in visual acuity, faricimab every 8 weeks (YOSEMITE 10.7 ETDRS letters and RHINE 11.8 ETDRS letters) and faricimab PTI (YOSEMITE 11.6 ETDRS letters and RHINE 10.8 ETDRS letters) were non-inferior to aflibercept every 8 weeks (YOSEMITE 10.9 ETDRS letters and RHINE 10.3 ETDRS letters). In addition, the proportion of adverse events between faricimab every 8 weeks (YOSEMITE 31%, RHINE 43%), faricimab PTI (YOSEMITE 34%, RHINE 37%), and aflibercept every 8 weeks (YOSEMITE 33%, RHINE 36%) were comparable. Findings from this study suggest that faricimab is effective for treatment of diabetic macular edema and its use should be considered in clinical practice.
Image: PD
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