The FDA has approved Genentech’s Vabysmo (first announced here as faricimab), the only injectable eye medicine approved simultaneously in the U.S. for wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
Vabysmo will be administered using flexible dosing regimens based on patient need. The medication targets and inhibits two disease pathways by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), which drive the two conditions.
Vabysmo is the first and only FDA-approved injectable eye medicine for wet AMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses. Standard of care for wet AMD and DME typically requires eye injections every one to two months.
“Vabysmo represents an important step forward for ophthalmology,” said Charles Wykoff, M.D., Ph.D. (Director of Research, Retina Consultants of Texas in Houston and a Vabysmo Phase III investigator). “With Vabysmo, we now have the opportunity to offer patients a medicine that could improve their vision, potentially lowering treatment burden with fewer injections over time.”
The approval is based on positive results across four Phase III studies in wet AMD and DME. The studies consistently showed that patients treated with Vabysmo given at intervals of up to four months achieved non-inferior vision gains versus Regeneron’s Eylea (aflibercept) given every two months in the first year. Vabysmo was generally well tolerated in all four studies, with a favorable benefit-risk profile.
More information and details about the research may be read here.
SOURCE: Genentech Press Release