AAO 2024: Roche’s Vabysmo improved vision in underrepresented populations with DME

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Roche announced positive topline one-year results from the open-label, single-arm phase IV ELEVATUM (NCT05224102) study evaluating faricimab (Vabysmo) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.4

Data were presented in a late-breaking oral presentation at the American Academy of Ophthalmology 2024 Annual Meeting in Chicago.1 The company noted the study is the first retina trial for historically underrepresented populations.¹

Initial data from the ELEVATUM study, which included 124 participants across the United States, have shown promising results for patients with diabetic macular edema (DME) treated with faricimab. After one year of treatment, administered every eight weeks, participants experienced an average gain of 12.3 letters in visual acuity, equating to roughly two and a half lines on an eye chart. These findings were consistent across all major racial and ethnic groups represented in the study.

Notably, Hispanic and Latino participants, who began the study with more advanced disease, achieved an average improvement of 14.1 letters—almost three lines on an eye chart. African American and Black participants also saw significant gains, with an average improvement of 11.3 letters after one year of treatment.

Faricimab was well tolerated among all participants, with no new safety concerns identified. "Vabysmo has demonstrated its efficacy as a first-line treatment for diabetic macular edema. For the first time, we have data showing its effectiveness specifically in Black, African American, Hispanic, and Latino patients—groups disproportionately impacted by this condition," said Jeremiah Brown, MD, of Retina Consultants of Texas, who presented the findings at the American Academy of Ophthalmology (AAO) annual meeting.

Brown emphasized the importance of participating in the study, hoping the results will enhance care for these populations.

"As a clinician who serves these communities, I believed it was crucial to be involved in this groundbreaking research. I hope these findings will guide and improve the care we provide every day," he said.

The study results align with previous data from the phase III YOSEMITE and RHINE studies, which demonstrated similar vision improvements and robust retinal drying with Vabysmo. A secondary endpoint of the ELEVATUM study revealed an average reduction of 206.3 microns in central subfield thickness (CST), a key indicator of retinal swelling, which is associated with distorted or blurred vision in DME.

Nilesh Mehta, Roche’s Global Therapeutic Area Head for Ophthalmology, noted that ELEVATUM was designed specifically to evaluate faricimab’s efficacy in underrepresented populations.

"Incorporating diverse populations is a key part of Roche’s broader Diversity, Equity, and Inclusion strategy. Improving our scientific understanding of DME within these groups will help elevate the standard of care for all patients affected by this condition," Mehta said in the news release.

Among the 124 participants in the study, 45% identified as Hispanic or Latino, and 48% as Black or African American. The study was intentionally conducted at sites serving a large proportion of these populations, including urban, rural, and community-based clinics. Additionally, eligibility criteria were adjusted to allow patients with higher HbA1c levels, up to 12%, to better reflect the realities of diabetes management in these populations.¹

Faricimab (Vabysmo) is now approved in more than 100 countries for the treatment of DME and neovascular age-related macular degeneration. Globally, over five million doses of the drug have been administered since its initial approval in 2022.

About ELEVATUM

ELEVATUM is a phase IV, multicenter, open-label study evaluating the safety and efficacy of faricimab for treating diabetic macular edema in historically underrepresented populations, including Black, African American, Hispanic, and Latino individuals. Patients received treatment every four weeks up to week 20, followed by every eight weeks until week 52. The study’s primary endpoint is the change in best-corrected visual acuity (BCVA) at week 56, with secondary endpoints including safety and changes in CST from baseline.

Reference

1. Roche HL. Roche’s Vabysmo improved vision in underrepresented populations with diabetic macular edema (DME) in a first-of-its-kind study. GlobeNewswire News Room. Published October 18, 2024. Accessed October 19, 2024. https://www.globenewswire.com/news-release/2024/10/18/2965750/0/en/Roche-s-Vabysmo-improved-vision-in-underrepresented-populations-with-diabetic-macular-edema-DME-in-a-first-of-its-kind-study.html