Faricimab Results in Better Vision and CST for Underrepresented Groups with DME

Year 1 results from the phase 4 ELEVATUM study have demonstrated robust vision and central subfield thickness (CST) improvements through faricimab in underrepresented patients with diabetic macular edema (DME).¹

This analysis of the open-label, single-arm, multicenter ELEVATUM study was presented at the 43^rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA by Andres Emanuelli, MD, University of Puerto Rico. The team investigated outcomes of Black, Hispanic/Latino American, and Native American/Native Hawaiian/Pacific Islander patients in the US, all of whom are typically underrepresented in ophthalmology trials.¹

There is ample literature suggesting the efficacy of faricimab in treating DME and diabetic retinopathy. Previous trials, most with majority White patients, have examined the effectiveness of anti-vascular endothelial growth factor (anti-VEGF) drugs like faricimab in reducing vascular leakage and moderating angiopoietin-like proteins, which play a significant role in cellular metabolism and may lead to retinal vascular disease.²

Emanuelli and colleagues selected treatment-naïve patients with DME to receive faricimab 6mg every 4 weeks (Q4W) to week 20, and then Q8W until week 52. The study’s primary endpoint was best-corrected visual acuity (BCVA) change from baseline to week 56. Secondary endpoints included CST change from baseline and the proportion of patients with ≥2-step Diabetic Retinopathy Severity Scale (DRSS) improvement at week 56.¹

Investigators noted that Hispanic/Latino American patients had numerically worse BCVA (n = 56, mean [standard deviation (SD)]: 59.2 [11.4] letters) and CST (491.1 [157.2] µm) at baseline, compared with Black patients (n = 59; 62.2 [10.2] letters and 467.4 [126] µm) and the overall study population (n = 123; 61.1 [11.1] letters and 476.9 [138.5] µm).¹

Week 56 saw adjusted mean (95% CI) BCVA changes from baseline of +14.1 (9.9-18.2), +11.3 (9-13.5), and +12.3 (10.2-14.5) letters in Hispanic/Latino American patients, Black patients, and the overall study population, respectively. Corresponding adjusted mean (95% CI) CST changes from baseline at week 56 were -230.5 (-252.1 to -208.6) µm, -193.9 (-215.2 to -172.7) µm, and -206.3 (-217 to -195.7) µm in Hispanic/Latino American patients, Black patients, and the overall study population, respectively.¹

DRSS improvement of ≥2 steps was achieved by 17.6% of Black patients, 41.5% of Hispanic/Latino patients, and 32.1% of the overall study population. Faricimab was well tolerated throughout the study, with a safety profile consistent with that established in the phase 3 YOSEMITE/RHINE trials and no new safety concerns identified.¹

“Year 1 results from ELEVATUM demonstrated robust vision and CST improvements with faricimab in underrepresented patients with DME in the US,” Emanuelli and colleagues wrote. “Hispanic/Latino American patients had the greatest improvements in BCVA, CST, and DR disease severity.”¹

References

1. Emanuelli A. Treatment Response and Safety of Faricimab in Underrepresented Patients with DME: Year 1 Results from ELEVATUM in the United States. Abstract presented at the 43^rd Annual Scientific Meeting of the American Society of Retina Specialists in Long Beach, CA, July 30-August 2, 2025.

2. Śpiewak D, Drzyzga Ł, Dorecka M, Witek K, Wyględowska-Promieńska D. Efficacy of Faricimab in the Treatment of Diabetic Macular Edema and Faricimab-Related Changes in OCT and OCT Angiography. Pharmaceutics. 2025;17(7):858. Published 2025 Jun 30. doi:10.3390/pharmaceutics17070858