
In the treatment of diabetic macular edema (DME) in the subgroup of patients with baseline best-corrected visual acuity (BCVA) of 20/50 or worse, the bispecific antibody faricimab has been shown to improve visual acuity as much as the anti-VEGF aflibercept, with the added advantage of a greater decrease in retinal thickness and reduced injection frequency.
Researchers conducted a post hoc subgroup analysis of the phase III YOSEMITE and RHINE trials, which were identically designed, multicentre, randomized, double-masked, active comparator–controlled, noninferiority trials.
The trials involved adults ≥18 years of age with centre-involving macular edema secondary to type 1 or 2 diabetes. The respective number of patients with baseline BCVA of 20/50 or worse in YOSEMITE and RHINE was 220 and 217 patients in the faricimab every 8 weeks (Q8W) arm, 220 and 219 patients in the faricimab treat-and-extend (T&E) arm, and 219 and 214 patients in the aflibercept Q8W arm.
In the subgroup with baseline BCVA of 20/50 or worse, the mean change in ETDRS BCVA at years 1 and 2 did not significantly between treatments across trials.
However, the change from baseline in central subfield thickness (CST) was greater with faricimab than with aflibercept. In YOSEMITE, the adjusted mean change in CST at year 1 was –232.8 μm with faricimab Q8W and –217.4 μm with faricimab T&E vs –190.4 μm with aflibercept (p<0.0001 and p=0.0004, respectively). In RHINE, the corresponding change was –214.2 and –206.6 vs –186.6 μm (p=0.0006 and p=0.0116, respectively). In both trials, the mean change from baseline in CST at year 2 was greater with faricimab Q8W than with aflibercept.
Patients treated with faricimab had a more rapid reduction in CST (time to first CST of <325 μm) and elimination of intraretinal fluid compared with those treated with aflibercept, requiring fewer injections overall.