Swiss pharmaceutical company Roche has released positive topline one-year findings from a Phase IV trial of Vabysmo (faricimab) to treat diabetic macular oedema (DME).
The multicentre, open-label, single-arm ELEVATUM trial focused on populations typically underrepresented in clinical research.
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Vabysmo is a bispecific antibody designed for ocular use that neutralises angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) and inhibits pathways that contribute to several severe retinal conditions.
The drug is the first of its kind to receive approval for DME.
The ELEVATUM study’s initial data showed significant vision improvements in 124 US participants, who were given Vabysmo every eight weeks for a year.
The study aimed to enrol subjects from underrepresented patient populations, with 45% of participants identifying as Hispanic or Latino and 48% as Black or African American.
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By GlobalDataRoche ophthalmology global therapeutic area head Nilesh Mehta said: “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 oedema and ultimately improve standard of care for all people living with this condition.”
Roche shared these results during a late-breaking oral presentation at the American Academy of Ophthalmology (AAO) 2024 Annual Meeting on 18 October.
Vabysmo has received approval in more than 100 countries for DME and wet age-related macular degeneration, as well as in over 30 countries for macular oedema following retinal vein occlusion (RVO).
Since its US approval in 2022, more than five million doses of the antibody have been distributed worldwide.
Earlier this year, Roche announced four-year results from the RHONE-X extension study, which evaluated the long-term safety and efficacy of Vabysmo in treating DME.
The study met all its primary endpoints, confirming that Vabysmo was well-tolerated by DME patients for up to four years.
