Roche to reintroduce ocular implant two years after pulling it off the market

Roche plans to reintroduce Susvimo, its ocular implant pulled almost two years ago for manufacturing issues, in the coming weeks.

In late 2022, the company’s Genentech unit withdrew the implant after an FDA recall related to the septum, or seal on the delivery device, which could fail after repeated dosing. But Genentech said they’ve made significant changes to fix those issues, which have now been approved by the FDA.

“Component-level updates to the implant and refill needle, and manufacturing process improvements have been implemented to ensure Susvimo implants meet our pre-specified performance specifications, mitigating the risk of septum dislodgement,” a Genentech spokesperson told Endpoints News via email.

The implant is surgically inserted into the eye as part of an outpatient procedure and is refilled once every six months with a custom formulation of the monoclonal antibody ranibizumab.

Genentech confirmed that updates to the implant and needle have…
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