Two-year results from the Phase 3 YOSEMITE and RHINE trials show that faricimab (Vabysmo, Genentech), a bispecific antibody targeting both angiopoietin-2 and VEGF-A, maintained visual acuity gains and anatomic improvements in patients with diabetic macular edema (DME) while allowing for extended dosing intervals. According to Tien Y. Wong, MD, PhD, and colleagues, faricimab administered every 8 weeks or in a treat-and-extend (T&E) regimen up to every 16 weeks demonstrated comparable efficacy to aflibercept (Eylea; Regeneron) given every 8 weeks, despite fewer injections in the T&E arm.
The studies included 1,891 patients across 353 sites worldwide. At 2 years, mean best-corrected visual acuity (BCVA) gains from baseline were +10.7 to +10.9 EDTRS letters for faricimab every 8 weeks, +10.1 to +10.7 letters for faricimab T&E, and +9.4 to +11.4 letters for aflibercept every 8 weeks. Notably, 78% of faricimab T&E patients achieved dosing intervals of 12 weeks or longer at week 96, including 60% to 64% at every 16 weeks.
Faricimab also demonstrated greater anatomic improvements versus aflibercept, with more patients achieving absence of DME and intraretinal fluid. The safety profile of faricimab remained consistent with prior results and comparable to aflibercept through study end, the researchers reported.
“These data reinforce the potential of dual inhibition of angiopoietin-2 and VEGF-A with faricimab as a novel, multitargeted strategy that may extend DME treatment durability and may improve outcomes beyond VEGF inhibition alone,” the researchers concluded. The findings suggest faricimab could reduce treatment burden for DME patients while maintaining efficacy, though further studies are needed to evaluate long-term outcomes.