Genentech Recalls Susvimo Implant After Finding Seal Can Leak

Roche announced Oct. 18 that it had initiated a voluntary recall of subsidiary Genentech’s Susvimo refillable ocular implant in the US.

Roche Pharmaceuticals CEO Bill Anderson said during the company’s Q3-2022 analyst call that the recall was based on recent testing of Susvimo commercial supply in which implants were exposed to repeated puncturing with a needle. The company found that the device’s seal could fail.

This could allow the drug to leak into the conjunctiva instead of disbursing to the retina, making the device ineffective.

New implantations have been paused, including those in clinical trials. The company said there is no medical reason to remove devices already implanted, and eligible patients can continue receiving refills.

Anderson said the company is making corrections to the manufacturing process and hopes to have Susvimo back on the market within a year.

The recall comes a year after Susvimo gained FDA approval, on Oct. 22, 2021. The implant is designed to continuously deliver a customized formulation of ranibizumab.

Susvimo, branded outside the US as the Port Delivery System with ranibizumab, is indicated for patients with wet age-related macular degeneration (AMD) who have previously responded to at least two anti-VEGF injections.

The implant is surgically inserted into the eye during a one-time, outpatient procedure and refilled every six months.

Susvimo has earned $3 million in revenue through three quarters of 2022, with lower-than-expected adoption, according to retina specialists at ophthalmic meetings.

Market Scope’s coverage of the 2022 AAO meeting in the October issue of “Ophthalmic Market Perspectives,” set for publishing Oct. 26, includes a lengthy discussion by doctors on their views and use of Susvimo.