Susvimo, an innovative refillable eye implant, has shown promising results in Phase III clinical trials for treating DME and DR, vision-threatening conditions related to diabetes.
Over two years, Susvimo demonstrated sustained effectiveness in maintaining visual acuity in DME patients and improving DRSS scores in DR patients. Its safety profile remained consistent with previous findings.
The FDA has accepted Genentech’s sBLA for Susvimo, based on one-year data from the Pagoda and Pavilion studies. These studies demonstrated significant improvements in visual outcomes for both conditions.
Susvimo’s unique mechanism of action involves continuous delivery of ranibizumab to the eye, eliminating the need for frequent injections. In DME studies, approximately 95% of patients receiving Susvimo required no supplemental injections during the six-month dosing interval.
Susvimo’s nine-month dosing interval for DR patients led to superior improvements in DRSS scores compared to traditional observation. Importantly, no Susvimo patients required additional injections.
Dr. Levi Garraway, Genentech’s chief medical officer, emphasized the potential of Susvimo to revolutionize the treatment of diabetic eye diseases. If approved by the FDA, it could provide a more convenient and effective approach to preserve vision and maintain independence in affected individuals.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.