Roche's Vabysmo (faricimab) has demonstrated significant vision improvements in underrepresented racial and ethnic groups with diabetic macular edema (DME), according to topline one-year results from the open-label, single-arm Phase IV ELEVATUM study. The findings, presented at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting, highlight Vabysmo's potential to address disparities in DME treatment outcomes.
Key Findings from the ELEVATUM Study
The ELEVATUM study, which included 124 participants in the United States, focused on evaluating Vabysmo in racial and ethnic groups historically underrepresented in clinical trials. After one year of treatment with Vabysmo, administered every eight weeks, participants showed an average improvement of 12.3 letters on an eye chart, which is equivalent to approximately two and a half lines.
Notably, Hispanic and Latino participants, who presented with more severe disease at baseline, experienced an average vision gain of 14.1 letters, nearly three lines on an eye chart. African American and Black participants also demonstrated significant improvements, with an average gain of 11.3 letters from baseline at one year.
Jeremiah Brown, M.D., of Retina Consultants of Texas, who presented the data at AAO, emphasized the importance of these findings. "Vabysmo has been shown to be an effective first-line treatment for diabetic macular edema, and for the first time, we have data specifically demonstrating its ability to improve vision in Black, African American, Hispanic and Latino patients who are disproportionately impacted by this condition," said Brown.
Retinal Drying and Safety Profile
Consistent with the Phase III YOSEMITE and RHINE DME studies, the ELEVATUM study also assessed retinal drying as a secondary endpoint. Participants across all racial and ethnic groups achieved an average decrease of 206.3 microns in central subfield thickness (CST) from baseline. A reduction in CST indicates retinal drying, a critical clinical measure, as retinal swelling from excess fluid is associated with blurred vision.
Vabysmo was well-tolerated among all participants, with no new safety events identified, reinforcing its favorable safety profile.
Addressing Underrepresentation in Clinical Trials
The ELEVATUM study was designed to facilitate the enrollment and retention of underrepresented patients. Conducted at sites that treat a high proportion of these populations in urban, rural, and community-based locations, the study also adjusted eligibility criteria to allow participants with a hemoglobin A1c (HbA1c) level up to 12%. This adjustment acknowledges that HbA1c levels can be higher in Black, African American, Hispanic, and Latino populations, preventing the inadvertent exclusion of these patients.
Nilesh Mehta, Roche’s Global Therapeutic Area Head for Ophthalmology, stated, "We established ELEVATUM to specifically evaluate Vabysmo in underrepresented populations. Including diverse populations and perspectives is part of our broader Roche Diversity, Equity & Inclusion (DE&I) strategy and is essential if we want to improve scientific understanding of diabetic macular edema and ultimately improve standard of care for all people living with this condition."
Vabysmo's Global Impact
Approved in over 100 countries for DME and neovascular age-related macular degeneration, Vabysmo has also been approved in over 30 countries for macular edema following retinal vein occlusion (RVO). Since its initial U.S. approval in 2022, more than five million doses of Vabysmo have been distributed globally.
