SOUTH SAN FRANCISCO (dpa-AFX) - Genentech, a member of the Roche Group (RHHBY) Thursday announced positive two-year data from the Phase III Pagoda and Pavilion studies evaluating Susvimo for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR), the two leading causes of vision loss in adults with diabetes.
Susvimo (ranibizumab 100 mg/mL) is a refillable implant surgically inserted into the eye that continuously delivers a customized formulation of ranibizumab over time.
In Pagoda study, people with DME receiving Susvimo refilled every six months through approximately two years continued to maintain improvements in vision gains seen at one year of 9.8 eye chart letters. In Pavilion, people with DR receiving Susvimo refilled every nine months through approximately two years maintained Diabetic Retinopathy Severity Scale (DRSS) improvements seen at one year. Further, Safety data were consistent with the known safety profile for Susvimo in people with DME and DR.
These results were presented at the American Society of Retina Specialists (ASRS) 2024 Annual Meeting in Stockholm, Sweden.
Additionally, the U.S. Food and Drug Administration or FDA has accepted Genentech's supplemental Biologics License Application for Susvimo for the treatment of DME and DR.
Susvimo is already approved in the U.S. for the treatment of wet, or neovascular, age-related macular degeneration (AMD).
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