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 a 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 been shared publicly at medical meetings this year, including at the Retina World Congress and the Macula Society meeting.
“The changes doubled the bonding strength of the septum to the implant,” a spokesperson added. “The refill needle has been updated, allowing the needle to be inserted into the septum more smoothly, which reduced the insertion force needed by more than 50%.”
The implant, which brought in 3 million Swiss francs ($3.4 million) in 2022 before its withdrawal, first won FDA approval in 2021. Roche acquired the implant in 2017 when it purchased ForSight VISION4 for an undisclosed sum.