Swiss pharmaceutical giant Roche (SWX: ROG) announced that it has received approval from the US Food and Drug Administration (FDA) for another indication of its Susvimo (ranibizumab) 100 mg/mL, this time to treat diabetic macular edema (DME). With this approval, Susvimo becomes the first and only FDA-approved treatment shown to maintain vision in people with DME with fewer treatments than standard-of-care eye injections.
Susvimo: A Refillable Eye Implant
Susvimo is a refillable eye implant that is surgically inserted into the eye during a one-time, outpatient procedure. It continuously delivers a customized formulation of ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor, over time. Compared to Novartis’ Lucentis (ranibizumab intravitreal injection), Susvimo only requires two refills per year, significantly reducing the treatment burden on patients.
Expanding Indications and Market Potential
The first FDA approval for Susvimo came in 2021 for its use in neovascular or “wet” age-related macular degeneration (nAMD). This new indication for DME further expands the potential market for Susvimo, positioning it as a leading treatment option for patients with vision-threatening retinal diseases. The approval underscores Roche’s ongoing commitment to innovation in ophthalmology.-Fineline Info & Tech
