Roche’s Vabysmo improved vision in underrepresented populations

Swiss pharma giant Roche (ROG: SIX) on Friday released positive top-line 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.

The company noted that initial data from 124 participants in the USA 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. Vabysmo was well tolerated, with no new safety events identified.

These data were presented in a late-breaking oral presentation at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting in Chicago, Illinois, on October 18. The study is the first retina trial for historically underrepresented populations, said Roche.