Vabysmo Enhanced Vision in Underrepresented DME Populations in Landmark Study

Genentech, part of the Roche Group, has announced promising one-year results from the Phase IV ELEVATUM study, which examined the efficacy of Vabysmo® (faricimab-svoa) in treating diabetic macular edema (DME) among underrepresented racial and ethnic populations. These groups, which include African American, Black, Hispanic, and Latino individuals, are often disproportionately affected by diabetes and consequently have a higher risk of developing DME, a significant cause of vision impairment.

The study, which enrolled 124 participants in the United States, revealed that after a year of bi-monthly Vabysmo treatments, patients experienced notable improvements in vision and reductions in retinal fluid. On average, participants could read 12.3 additional letters on an eye chart, translating to roughly two and a half lines. The results were consistent across different racial and ethnic groups within the study. Notably, Hispanic and Latino participants, who began with more severe disease states, saw an average improvement of 14.1 letters, nearly three lines on an eye chart. African American and Black participants experienced an average gain of 11.3 letters. Importantly, Vabysmo was well-tolerated, with no new safety issues identified.

These findings were presented at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting in Chicago, marking the first retina trial focusing on historically underrepresented populations. Dr. Jeremiah Brown of Retina Consultants of Texas, who presented the data at AAO, emphasized the significance of these results for patients in these communities who are disproportionately affected by DME.

The data from ELEVATUM aligns with results from previous Phase III studies, YOSEMITE and RHINE, highlighting Vabysmo's robust efficacy. A secondary endpoint demonstrated significant retinal drying across racial and ethnic groups, with an average decrease of 206.3 microns in central subfield thickness.

The ELEVATUM study was designed to address the underrepresentation of certain racial and ethnic groups in clinical trials. Among the participants, 45% identified as Hispanic or Latino, and 48% as Black or African American. The study aimed to facilitate enrollment and retention of these populations by conducting trials at locations that predominantly serve these communities, including urban, rural, and community-based sites. Additionally, the study set more inclusive eligibility criteria, allowing participants with a hemoglobin A1c (HbA1c) level up to 12%, higher than the typical threshold of 10% in DME trials. This was done to avoid excluding individuals from these racial and ethnic groups, who tend to have higher HbA1c levels.

Gregory A. Rippon, M.D., Vice President of U.S. Medical Affairs, highlighted the importance of this study in understanding how underrepresented populations respond to Vabysmo, aiming to improve equitable care and influence future clinical trial designs. Quita Highsmith, Vice President and Chief Diversity Officer at Genentech, echoed this sentiment, emphasizing the company's commitment to inclusive research practices.

Vabysmo is currently approved in over 100 countries for the treatment of DME and neovascular age-related macular degeneration (AMD), and in more than 30 countries for macular edema following retinal vein occlusion (RVO). Since its initial U.S. approval in 2022, over five million doses have been distributed globally.

Genentech continues to provide comprehensive services to help patients access Vabysmo, including assistance programs aimed at minimizing barriers to access and reimbursement. The company is dedicated to advancing research in ophthalmology, developing new treatments, and addressing health disparities through inclusive research practices.