The FDA has approved Roche's Genentech's Susvimo for the treatment of diabetic macular edema
The FDA has approved Roche's Genentech's Susvimo for the treatment of diabetic macular edema (DME). Susvimo is the first continuous delivery treatment that can replace conventional eye injections, requiring only two treatments per year to help patients maintain their vision. The drug is implanted through a one-time outpatient procedure, using ranibizumab as a VEGF inhibitor. This approval is based on positive results from a Phase III clinical study
According to the Zhitong Finance APP, on February 4th local time, Roche (RHHBY.US) subsidiary Genentech announced that the FDA has approved 100 mg/mL Susvimo (Ranibizumab-RG6321) for the treatment of Diabetic Macular Edema (DME). The press release stated that Susvimo is the first and only sustained delivery treatment for DME that can replace conventional eye injections, requiring treatment only twice a year to help DME patients maintain their vision.
Susvimo is a refillable ocular implant that can be implanted into the patient's eye through a one-time outpatient procedure for intravitreal injection. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind and inhibit VEGF-A, a protein that has been shown to play a key role in neovascularization and vascular leakage. Currently, Susvimo has been approved in the United States for two indications: wet age-related macular degeneration and diabetic macular edema (DME).
This approval is based on positive results from a Phase III Pagoda one-year clinical study. Pagoda (NCT04108156) is a multicenter, randomized, active treatment-controlled, non-inferiority Phase III study conducted in the United States. The study evaluated the efficacy, safety, and pharmacokinetics of supplementing 100 mg/mL Susvimo every six months compared to monthly intravitreal injections of 0.5 mg Ranibizumab in 634 DME patients. The primary endpoint of the study was to assess the change in best-corrected visual acuity score relative to baseline at 60 weeks and 64 weeks
