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FDA Approves Susvimo for Diabetic Macular Edema

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The FDA’s approval marks the second indication for Genentech's refillable ocular implant in addition to wet age-related macular degeneration.

The US Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant as the first and only continuous delivery treatment for diabetic macular edema (DME).1

Announced by Genentech on February 4, 2025, the approval represented the second indication for Susvimo, formerly known as the Port Delivery System with ranibizumab, following its initial approval in 2021 for neovascular (wet) age-related macular degeneration (nAMD).2

“I am excited to offer Susvimo to my patients living with DME who want an option with longer intervals between treatments due to their busy personal and professional lives,” said Jordan Graff, MD, Barnet Dulaney Perkins Eye Center, in a statement.1 “Having completed dozens of Susvimo surgeries in my patients with nAMD, I’ve seen firsthand how Susvimo, with its continuous delivery of medication, can help preserve vision with fewer treatments.”

Vision outcomes among nearly 750,000 individuals in the US and 29 million globally are impacted by DME, a retinal condition that occurs from damaged blood vessels in the retina. This number is anticipated to grow as the prevalence of diabetes increases worldwide, marking a significant public health concern as the disease can substantially reduce quality of life.3

Susvumo is a refillable implant inserted into the eye during a single, outpatient procedure delivering a customized formulation of ranibizumab, a key vascular endothelial growth factor (VEGF) inhibitor designed to bind to VEGF-A.4 The FDA’s green light was awarded based on positive 1-year results from the multicenter, randomized, active treatment-controlled, non-inferiority Phase 3 Pagoda Study.1

The trial evaluated the efficacy, safety, and pharmacokinetics of Susvimo refilled every 6 months compared with monthly ranibizumab 0.5 mg injections across 634 people with DME. In the Susvimo arm, participants received four loading doses of intravitreal ranibizumab before Susvimo implantation at Week 16.

In the trial, Susvimo achieved continuous vision improvement in individuals with DME, while remaining consistent with the known safety profile for Susvimo. Those with DME who received Susvimo refilled every six months achieved non-inferior improvements in vision compared with monthly 0.5 mg ranibizumab intravitreal injections (9.6 ETDRS letters vs. 9.4 ETDRS letters, respectively).

In the release, Genentech announced Susvimo marked the first and only FDA-approved treatment to maintain vision in people with DME with fewer injections than the standard of care monthly injections. The company indicated Susvimo is now available to US retina specialists and patients with DME.

“Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition,” said Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech.1 “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.”

At the American Society of Retina Specialists (ASRS) 42nd Annual Meeting, Carl C. Awh, MD, Tennessee Retina, described long-term functional and anatomical benefits of Susvimo with every-6-month refill exchanges in DME, based on positive 2-year results from Pagoda.5

References

  1. FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness. Genentech: Press Releases | Tuesday, Feb 4, 2025. 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.
  2. Iapoce C. Genentech announces reintroduction of Susvimo for Wet Amd. HCP Live. July 8, 2024. Accessed February 4, 2025. https://www.hcplive.com/view/genentech-announces-reintroduction-of-susvimo-for-wet-amd.
  3. Duphare C, Desai K, Gupta P, et al. Diabetic Macular Edema. [Updated 2023 May 23]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554384/
  4. Iapoce C. FDA accepts sBLA for Susvimo in treatment of DME, diabetic retinopathy. HCP Live. July 23, 2024. Accessed February 4, 2025. https://www.hcplive.com/view/fda-accepts-sbla-for-susvimo-in-treatment-of-dme-diabetic-retinopathy.
  5. Iapoce C. Carl C. AWH, MD: Two-year outcomes of the Port Delivery System for DME. HCP Live. July 20, 2024. Accessed February 4, 2025. https://www.hcplive.com/view/carl-c-awh-md-two-year-outcomes-port-delivery-system-dme.


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