Faricimab Superior to Aflibercept in Disease Control in Diabetic Macular Edema

According to recent research, faricimab exhibits a greater reduction in hard exudate (HE) reduction than aflibercept in patients with diabetic macular edema (DME), implying improved vascular stability and disease control.1

Presented at the 43rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, by Murtaza Adam, MD, Colorado Retina Associates, this exploratory analysis examined results from the phase 3 YOSEMITE/RHINE trials to quantify HEs within all possible subfields of the 3-mm diameter Early Treatment Diabetic Retinopathy Study (ETDRS) grid on spectral-domain optical coherence tomography (SD-OCT). Investigators utilized a deep-learning algorithm to evaluate the impact of dual angiopoietin (Ang)-2/vascular endothelial growth factor (VEGF)-A inhibition with faricimab versus aflibercept over time.1

Previous research investigating SD-OCT scans from YOSEMITE/RHINE noted a greater reduction of hyperreflective foci by faricimab versus aflibercept. Although taking place over a shorter study period, this earlier trial corroborates the findings of Adam and colleagues. It establishes a precedent of the greater therapeutic potential of dual Ang-2/VEGF-A inhibition in suppressing DME disease activity.2

A total of 1552 patients were selected for the study, all of whom exhibited OCT Heidelberg Spectralis images available at baseline. These pateints were randomized 1:1:1 to intravitreal faricimab 6mg every 9 weeks (Q8W; n = 626), faricimab 6mg treat-and-extend (T&E; n = 628), or aflibercept 2mg Q8W (n = 616). An automated, deep-learning-based algorithm was used to quantify HEs (hyperreflective objects ≥50 µm) automatically in SD-OCT volume scans from baseline to week 100.1

The team assessed HE volumes across the 3mm diameter ETDRS grid and within each subfield; center 1mm and inferior, temporal, nasal, and superior quadrants. The 3 treatment groups were compared using a mixed model for repeated measures.1

Adam and colleagues conducted a quantitative assessment of HEs, which revealed higher mean volumes in the inferior (9.4 nL) and temporal (8.5 nL) subfields of the 3-mm ETDRS grid at baseline across all treatment groups. HE reductions favored faricimab Q8W and T&E versus aflibercept across all subfields within the 3mm ETDRS grid.1

The center 1mm subfield saw greater mean HE volume changes from baseline at week 100 with faricimab Q8W and T&E (-.09 nL; 95% CI, -.13 to -.06) versus aflibercept (-.03; 95% CI, -.05 to -.02; nominal P = .0028 and P = .0024, respectively). Adjusted mean HE volume reductions were also greater with faricimab Q8W and T&E versus aflibercept in the inferior subfield (-.53 nL [95% CI, -.7 to -.39] and -.39 nL [95% CI, -.53 to -.27] versus -.18 nL [95% CI, -.26 to -.1], nominal P <.0001 and P = .0029) and temporal subfield (-.37 nL [95% CI, -.51 to -.26] and -.24 nL [95% CI, -.34 to -.16] versus -.1 nL [95% CI, -.17 to -.06], nominal P <.0001 and P = .013).1

“Quantitative OCT assessment demonstrated that HE volume was highest in the temporal and inferior subfields at baseline,” Adam and colleagues wrote. “Over time, faricimab demonstrated greater HE reduction [versus] aflibercept in all ETDRS subfields, suggesting improved vascular stability and disease control with dual Ang-2/VEGF-A inhibition in patients with DME.”1

References

1. Adam M. Volumetric Analysis of Hard Exudates on Optical Coherence Tomography: Biomarker Results of Faricimab vs Aflibercept From Phase 3 YOSEMITE/RHINE. Abstract presented at the 43rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, July 30-August 2, 2025.

2. Chakravarthy U, Chaudhary V, Sadda SR, et al. Effect of Faricimab versus Aflibercept on Hyperreflective Foci in Patients with Diabetic Macular Edema from the YOSEMITE/RHINE Trials. Ophthalmol Sci. 2025;5(5):100798. Published 2025 Apr 19. doi:10.1016/j.xops.2025.100798