Genentech’s Susvimo Gets FDA Nod as Continuous Delivery Treatment for Diabetes-Related Blindness

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Genentech, a member of the Roche Group, announce on Feb. 4, 2025 that FDA has approved ranibizumab injection (brand name Susvimo) 100 mg/mL for treating diabetic macular edema (DME), which causes vision loss in adults with diabetes. DME affects more than 29 million adults worldwide. This approval marks the second indication for ranibizumab, which was also approved to treat neovascular age-related macular degeneration (AMD) by FDA in 2021. This approval also makes ranibizumab the first and only FDA-approved treatment that can maintain vision in people with DME using fewer treatments compared to standard-of-care eye injections, according to a company press release (1).

FDA’s approval was based on positive one-year results from a Phase III study (Pagoda) in which ranibizumab demonstrated sustained vision improvements in people with DME. The safety profile in the study was consistent with the known safety profile for ranibizumab. DME patients who received the therapy with a refill every six months achieved “non-inferior improvements” in vision compared with patients receiving monthly administration of 0.5 mg ranibizumab intravitreal injections (1).

“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, Genentech, in the press release (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.”

Ranibizumab injection 100 mg/mL works by providing a continuous delivery of a ranibizumab formulation that has been customized. It is administered via the Port Delivery Platform, which is “an innovative intraocular drug delivery system designed for the continuous delivery of ranibizumab into the vitreous for [six] months and beyond” (2). Included in this delivery system, in addition to the customized formulation of ranibizumab, are an ocular implant and four dedicated ancillary devices used for initial fill, surgical implantation, refill-exchange, and explantation—if clinically indicated (2). In comparison, other currently approved DME treatments may require repeated eye injections as often as once per month.

“I am excited to offer Susvimo to my patients living with diabetic macular edema who want an option with longer intervals between treatments due to their busy personal and professional lives,” said vitreoretinal surgeon, Jordan Graff, MD, Barnet Dulaney Perkins Eye Center, Arizona, in the release. “Having completed dozens of Susvimo surgeries in my patients with wet, or neovascular, age-related macular degeneration, I’ve seen firsthand how Susvimo, with its continuous delivery of medication, can help preserve vision with fewer treatments. I look forward to broadening Susvimo’s impact to even more patients in my clinic.”

DME affects approximately 750,000 people in the United States and 29 million people globally (1). It threatens the patient’s vision and is associated with blindness and decreased quality of life if left untreated. DME is caused by damaged blood vessels in the retina leaking into the macula and causing swelling. The number of people affected with DME is expected to grow with the increasingly prevalence of diabetes in populations.

References

1. Genentech. FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness. Press Release. Feb. 4, 2025.
2. Ranade, S.V.; Wieland, M.R.; Tam, T.; et al. The Port Delivery System with Ranibizumab: a New Paradigm for Long-Acting Retinal Drug Delivery. Drug Deliv. 2022, 29 (1), 1326–1334. DOI: 10.1080/10717544.2022.2069301