FDA approves continuous delivery ranibizumab injection (Susvimo) for the treatment of diabetic macular edema

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The US Food and Drug Administration (FDA) has approved ranibizumab injection) 100 mg/mL (Susvimo; Genentech) for the treatment of diabetic macular edema (DME). The company noted that Susvimo is 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 100 mg/mL for intravitreal use via ocular implant is a refillable implant surgically inserted into the eye during a one-time, outpatient procedure, continuously delivering a customized formulation of ranibizumab over time. Susvimo was previously called the Port Delivery System with ranibizumab in the US.

Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development, Genentech, discussed the approval in a press release from the company.

“Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” said Garraway “As the global prevalence of this condition continues to grow, today's FDA approval for Susvimo reflects our dedication to innovation and enhancing the patient experience.”

The company stated the approval from the FDA was based on positive one-year results from the Phase III Pagoda study (NCT04108156). The Pagoda study was a multicenter, randomized, active treatment-controlled, non-inferiority US-based Phase III study evaluating the efficacy, safety and pharmacokinetics of Susvimo100 mg/mL refilled every 6 months compared with monthly ranibizumab 0.5 mg intravitreal injections. The trial enrolled 634 patients, randomized 3:2 to receive either Susvimo refilled every 6 months or continued monthly intravitreal ranibizumab injections.

Susvimo demonstrated sustained vision improvements in people with DME. Patients with DME receiving Susvimo refilled every 6 months achieved non-inferior improvements in vision compared with those receiving monthly 0.5 mg ranibizumab intravitreal injections.

According to the company, Susvimo is now available to US retina specialists and their patients with DME. Susvimo was first approved by the FDA for the treatment of wet, or neovascular age-related macular degeneration (AMD) in 2021.

Reference:

1. FDA approves Genentech’s Susvimo as the first and only continuous delivery treatment for the leading cause of diabetes-related blindness. Published February 4, 2025. Accessed February 4, 2025. https://www.gene.com/media/press-releases/15050/2025-02-04/fda-approves-genentechs-susvimo-as-the-f