Genentech to re-introduce Susvimo for wet AMD
Key Takeaways
- Genentech is re-introducing Susvimo, it’s port delivery system (PDS), which provides continual release of anti-VEGF medication for the treatment of wet age-related macular degeneration (AMD).
Once implanted, the PDS may be refilled as infrequently as twice a year, thereby reducing the treatment burden for patients.
Genentech is re-introducing Susvimo™, its port delivery system (PDS), for the treatment of wet AMD. The PDS, a refillable capsule the size of a rice grain, provides continual release of ranibizumab, an anti-VEGF protein that blocks the growth of vision-robbing, leaky blood vessels, which are the hallmarks of wet AMD.
The PDS is implanted at the surface of the eye during a one-time, outpatient surgical procedure. The PDS may be refilled as infrequently as twice a year, thereby reducing the treatment burden for patients. Other wet AMD therapies require regular injections into the vitreous, the soft gel in the middle of the eye.
Susvimo was approved by the US Food & Drug Administration (FDA) in October 2021 but was voluntarily recalled by Genentech in October 2022 after reports of dislodgement of the device’s septum, a self-sealing interface through which ranibizumab is administered into the implant both prior to insertion and during refills. Prior to the recall, clinical trials showed similar vision outcomes between the ranibizumab implant, with refills every 6 months, and monthly intravitreal injections of the anti-VEGF agent. Assessment of patient-reported outcomes showed that patients overwhelmingly preferred the device and its reduced treatment burden over conventional injections. Studies ongoing at the time of the recall showed similar long-term outcomes compared with monthly intravitreal anti-VEGF injections.
The FDA has approved a post-approval supplement to the Biologics License Application for Susvimo, reflecting component-level updates made to the ocular implant and refill needle. Genentech plans to make Susvimo available in the US to retina specialists and their patients with wet AMD in the coming weeks.
Edited by Miriam Kaplan, PhD
Sources:
Foundation Fighting Blindness, Eye on the Cure Research News, July 8, 2024; see source article
Charles Bankhead, MedPage Today, July 8, 2024; see source article