Roche (RHHBY) has reported encouraging one-year topline results from the phase IV ELEVATUM study, which is an open-label, single-arm investigation assessing the effectiveness of Vabysmo (faricimab) in treating diabetic macular edema (DME) among racially and ethnically diverse groups often underrepresented in clinical research.
The company shared that preliminary data, derived from 124 participants in the United States, reveal that after a year of receiving Vabysmo every eight weeks, participants, on average, improved their visual acuity by 12.3 letters—equivalent to gaining roughly two and a half lines on an eye chart. This trend was consistent across the principal racial and ethnic groups involved. Notably, Hispanic and Latino participants began the study with the most severe symptoms and showed an average vision enhancement of 14.1 letters from their baseline after one year, equating to nearly three lines on an eye chart. Meanwhile, African American and Black participants experienced an average improvement of 11.3 letters from their baseline at the one-year mark.
The effectiveness and safety profile observed in this phase IV study aligns with findings from the phase III DME studies of Vabysmo. A secondary endpoint revealed significant retinal drying across the racial and ethnic categories, showing an average reduction of 206.3 microns in central subfield thickness (CST) from baseline. This reduction in CST is indicative of retinal drying, a crucial clinical indicator, given that swelling due to excess fluid at the eye's rear is associated with distorted and blurred vision.
