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Data presented at ADA 2021 supports the noninferiority of faricimab to aflibercept.
Results from the ongoing Phase 3 YOSEMITE and RHINE trials showed that faricimab was noninferior to aflibercept in terms of visual acuity gains in patients with diabetic macular edema (DME).
These findings were presented by Allen Hu, MD, of Meritus Medical Center, at the American Diabetes Association (ADA) 2021 Virtual Sessions.
While anti-VEGF therapy is standard of care for patients living with DME, it nonetheless remains difficult to achieve the most optimal vision outcomes. Even more, consistent and sometimes monthly injections can place a burden on patients, their caregivers, and as well as the health care system.
“Upregulation of both VEGF-A and angiopoietin-2 has been shown to synergistically induce vascular destabilization characteristic of DME,” Hu and colleagues wrote. “Therefore, dual inhibition with faricimab, the first bispecific antibody designed for intraocular use, may improve outcomes beyond anti-VEGF monotherapy.”
The identical trials assessed the efficacy, durability, and safety of faricimab, an investigational bispecific therapy targeting the aforementioned pathways.
All patients were randomized 1:1:1 to faricimab 6.0 every 8 weeks following 6 initial doses every 4 weeks, 6.0 mg per personalized treatment interval (PTI) following 4 initial doses every 4 weeks, and aflibercept 2.0 mg every 8 weeks following 5 initial doses every 4 weeks.
The investigators adjusted dosing intervals in the PTI arms according to treatment response measured by prespecified vision and anatomic criteria.
As such, the primary endpoint was the mean change in best-corrected visual acuity at year 1, which was averaged over weeks 48, 52, and 56.
Notably, these endpoints were met in both studies, showing a noninferiority between faricimab and aflibercept in 8-week dosing intervals. PTI was also non-inferior to aflibercept dosed every 8 weeks.
PTI treatment was associated with an extended 16-week interval between injections in more than >50% of patients, the first time such durability has been observed in a Phase 3 study for DME.
Furthermore, no new safety signals were reported from these results.
In February, the investigators reported that the patients in the YOSEMITE PTI group achieved average vision gains of +11.6 eye chart letters—versus +10.7 for patients in the 8-week interval group and +10.9 letters in the aflibercept group.
In the RHINE study, the average vision gains from baseline were +10.8 and +11.8 letters in the personalized dosing and 8-week arms, respectively—compared with +10.3 letters in the aflibercept arm.
The team are currently assessing efficacy and safety results through 100 weeks of treatment.