Q&A: Susvimo delivers immediate durability after implantation in wet AMD
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Key takeaways:
- Genentech plans to reintroduce Susvimo for the treatment of wet age-related macular degeneration.
- The company is also investigating other medicines for use with the port delivery system.
Nearly 2 years after it voluntarily recalled Susvimo, Genentech recently announced plans to reintroduce the implant.
In July, the FDA approved a post-approval supplement to the biologics license application for Susvimo (ranibizumab injection 100 mg/mL), which continuously delivers a customized formulation of ranibizumab through the port delivery platform for the treatment of wet age-related macular degeneration. Susvimo is inserted during a one-time outpatient procedure and refilled every 6 months.
Healio spoke with Chris Brittain, senior vice president and global head of ophthalmology product development at Genentech, about the reintroduction of Susvimo and future plans for the port delivery platform.
Healio: What are the upcoming plans for Susvimo?
Brittain: We are planning to reintroduce Susvimo for wet AMD patients, whereby it continuously delivers a customized formulation of ranibizumab through a refillable implant. It is the first and only approved wet AMD treatment to maintain vision with two refills per year, as demonstrated in the phase 3 Archway study. We are looking forward to bringing Susvimo back to retina specialists in the United States following the FDA approval of the supplement.
Healio: How can Susvimo fill unmet needs in the management of wet AMD?
Brittain: Susvimo is the first-of-its-kind alternative to regular eye injections, which are the standard of care for wet AMD. Wet AMD impacts about 1.5 million adults in the U.S. and about 20 million people worldwide. While intravitreal injections have been a successful treatment for many people with retinal conditions, there are individuals who need a different option. For example, for patients with wet AMD who are receiving intravitreal injections, it can take them a year or more on these treat-and-extend regimens before they can go to three or four monthly intervals between treatments.
However, when you have Susvimo, people with wet AMD are able to go 6 months between refills immediately upon receiving the implant. This provides predictable and immediate durability. In the Archway study, about 95% of patients did not need additional treatment at the 1-year mark. Patients really appreciate that outstanding durability.
Healio: How has previous research informed future plans for Susvimo?
Brittain: The Archway study showed us that patients treated with Susvimo achieved and maintained vision gains that were equivalent to monthly ranibizumab injections. We are also investigating Susvimo in diabetic eye diseases, both diabetic macular edema and diabetic retinopathy. We were excited to have 2-year data from the Pagoda study in DME and Pavilion study in DR presented at the American Society of Retina Specialists annual meeting in Stockholm in July. The FDA has accepted the filing application for Susvimo in DME and DR based on 1-year Pagoda and Pavilion study data.
The port delivery platform is also being studied with investigational medicines. We are already investigating our first new molecule with the implant, which is called zifibancimig. It is a bispecific molecule targeting VEGF and angiopoietin-2, and it is in a phase 1b study called BURGUNDY. We are excited, and we have a lot of advances coming for retinal diseases that cause vision loss.
References:
- Genentech to reintroduce Susvimo for people with wet age-related macular degeneration (AMD). https://www.gene.com/media/press-releases/15031/2024-07-08/genentech-to-reintroduce-susvimo-for-peo. Published July 8, 2024. Accessed July 12, 2024.
- New data for Genentech’s Susvimo demonstrates sustained efficacy in two serious diabetic eye conditions. https://www.gene.com/media/press-releases/15034/2024-07-18/new-data-for-genentechs-susvimo-demonstr. Published July 18, 2024. Accessed Aug. 7, 2024.
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