FDA Approves Roche’s Susvimo for Diabetic Macular Edema

Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME), a major cause of vision loss in adults with diabetes. Susvimo is the first and only FDA-approved treatment that maintains vision with fewer injections than traditional therapies. This approval is a significant milestone for the millions of people living with DME worldwide. Roche is now making Susvimo available to U.S. retina specialists and their patients.

Dr. Levi Garraway, Roche’s Chief Medical Officer, highlighted Susvimo’s role in enhancing patient convenience and reducing the burden of frequent eye injections. Supported by positive Phase III Pagoda study results, Susvimo demonstrated sustained vision improvements with biannual refills, offering an alternative to monthly injections. Dr. Jordan Graff, a leading vitreoretinal surgeon, expressed optimism about the treatment’s impact on patients managing DME alongside busy lifestyles. Roche continues discussions with global regulatory agencies to expand Susvimo’s availability, reinforcing its commitment to advancing retinal disease treatments.