SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY) announced positive topline one-year results from the open-label, single-arm phase IV ELEVATUM study evaluating Vabysmo (faricimab) for the treatment of diabetic macular edema (DME) in people from racial and ethnic groups that are often underrepresented in clinical trials.
According to the company, initial data from 124 participants in the United States showed that after one year of treatment with Vabysmo, administered every eight weeks, participants could read an additional 12.3 letters on average - equivalent to about two and a half lines on an eye chart. Results among major racial and ethnic groups represented in this study were similar. Hispanic and Latino participants started the study with the most severe disease and had an average vision gain of 14.1 letters from baseline at one year, equivalent to nearly three lines on an eye chart. African American and Black participants gained an average of 11.3 letters from baseline at one year.
Efficacy and safety from this phase IV study were consistent with data from the Vabysmo phase III DME studies. A secondary endpoint showed robust retinal drying with Vabysmo across these racial and ethnic groups, who, on average, achieved a decrease of 206.3 microns in central subfield thickness (CST) from baseline. Reducing CST indicates retinal drying, which is an important clinical measure, as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.
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