USA—Genentech, a subsidiary of Roche Group, has relaunched its eye implant, Susvimo, in the United States following the conclusion of a voluntary recall, with the device expected to be available to patients in the coming weeks.

According to Genentech, the Susvimo implant is surgically inserted into the eye during a one-time, outpatient procedure and is refilled once every six months using a specially designed needle.

This needle introduces a customized formulation of ranibizumab directly into the device, which is crucial for treating wet, or neovascular, age-related macular degeneration (AMD).

Susvimo was initially approved by the FDA in 2021 to treat this chronic disorder that causes blurred vision.

However, in 2022, Genentech voluntarily recalled the ocular implant, insertion tool, and initial fill kit in the U.S.

This decision came after test results showed that some implants did not meet Genentech’s standards.

Since then, Genentech has updated the Susvimo implant and refill needle, and testing has confirmed that they now meet these performance standards.

Additionally, manufacturing process improvements were implemented to ensure quality.

The reintroduction of Susvimo offers the first alternative to the regular eye injections that are currently the standard of care for wet AMD.

 This condition affects 1.5 million people in the U.S. and 20 million people worldwide, and if left untreated, it can cause blindness.

This re-launch follows the U.S. Food and Drug Administration (FDA) post-approval supplement to the Biologics License Application for Susvimo, reflecting the component-level updates to the ocular implant and refill needle.

Commenting on the reintroduction, Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, expressed pleasure that they could reintroduce Susvimo, a unique therapeutic approach shown to provide an effective alternative to regular eye injections.

He emphasized that in Phase III studies, patients with wet AMD preserved their vision with just two refills per year.

He further added that Susvimo’s return to the retina community reflects their unwavering commitment to providing innovative retinal treatments and lays the groundwork for future advancements.

Genentech will work to make Susvimo available in the U.S. to retina specialists and their patients with wet AMD in the coming weeks.

Susvimo provides continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform, while other currently approved treatments may require multiple eye injections per year.

By continuously delivering medicine to the eye through a refillable implant, Susvimo is the first and only approved wet AMD treatment shown to maintain vision with just two refills a year.

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