The US Food and Drug Administration (FDA) has approved Genentech’s Susvimo (ranibizumab injection 100 mg/mL) for the treatment of diabetic retinopathy (DR), expanding the drug’s use beyond its current indications for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). Susvimo is the first and only continuous delivery system approved for DR, requiring just 1 treatment every 9 months.
Figure 1. Susvimo (Genentech) works by continuously delivering a customized formulation of ranibizumab into the eye through a surgically implanted, refillable ocular device, reducing the need for frequent injections.
Susvimo delivers a customized formulation of ranibizumab via a surgically implanted, refillable ocular device (Figure 1). The implant, which uses Genentech’s port delivery system, provides an alternative to monthly anti-VEGF injections, the current standard of care.
The approval is based on results from the phase 3 PAVILION study, which showed that patients with Susvimo showed greater improvement in DR severity compared to observation with treatment as needed. No patients receiving Susvimo required additional treatment during the first year, the company said in a press release.
Genentech said Susvimo is now available to US retina specialists and patients who have previously responded to anti-VEGF injections. The company also announced support programs to assist with access and reimbursement, with more information available at https://www.Genentech-Access.com. RP