Genentech Announces Reintroduction of Susvimo for Wet AMD

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Marking the end of a voluntary recall, the FDA approved updates to Susvimo regarding the ocular implant and refill needle.

Genentech Announces Reintroduction of Susvimo for Wet AMD Treatment | Image Credit: Unsplash/Perchek Industries

Credit: Unsplash/Perchek Industries

Genentech has signaled the reintroduction of Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via an ocular implant for neovascular (wet) age-related macular degeneration (nAMD), marking the end of a voluntary recall.1

Announced on July 8, 2024, the US Food and Drug Administration (FDA) granted a post-approval supplement to the Biologics License Application for Susvimo® based on component-level updates to the ocular implant and refill needle.

In the release, Genentech declared their plan to make Susvimo available to US retina specialists for the treatment of nAMD in the coming weeks.

“In my practice, I see many patients who are at risk of losing vision due to wet AMD and face a high burden of treatment,” said David Almeida, MD, MBA, PhD, founder of Erie Retina Research. “I’m excited to offer these patients Susvimo as an effective alternative to regular eye injections to help preserve their vision, without the need for frequent treatments.”

Susvimo provides continuous delivery of a customized formulation of ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor, via an ocular implant. The ocular implant is surgically inserted into the eye in a one-time, outpatient procedure and refilled once every 6 months using a specifically designed needle.

Formerly known as the Port Delivery System (PDS) with ranibizumab, initial FDA approval for Susvimo arrived in October 2021.2 By October 2022, Genentech voluntarily recalled Susvimo after the ocular implant, insertion tool, and initial fill kit after test results failed to perform to the company’s standards.3

Since the recall, Genentech indicated the Susvimo implant and refill needle were updated and testing has confirmed both are up to the designation performance standards.1 The company also announced the implementation of manufacturing process improvements.

Other approved treatments for nAMD typically require multiple eye injections per year, while Susvimo marks an alternative to the standard of care with continuous medicine delivery through a refillable implant. Genentech indicated Susvimo is the first approved nAMD treatment with demonstrated vision maintenance with two yearly refills.

“We are pleased to reintroduce Susvimo, a unique therapeutic approach shown to provide an effective alternative to regular eye injections by preserving vision with two refills per year in Phase III study patients with wet AMD,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development at Genentech. “Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements.”

References

  1. Genentech to Reintroduce Susvimo for People With Wet Age-Related Macular Degeneration (AMD). Genentech: Press Releases | Monday, Jul 8, 2024. July 8, 2024. Accessed July 8, 2024. https://www.gene.com/media/press-releases/15031/2024-07-08/genentech-to-reintroduce-susvimo-for-peo.
  2. Kunzmann K. FDA approves port delivery system with ranibizumab for Wet AMD. HCP Live. October 22, 2021. Accessed July 8, 2024. https://www.hcplive.com/view/fda-approves-port-delivery-system-ranibizumab-wet-amd.
  3. US DHCP voluntary recall of the SUSVIMO ocular implant ... Accessed July 8, 2024. https://www.gene.com/download/pdf/Susvimo_DHCP_Important_Prescribing_Information_2022-10-18.pdf.
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