Genentech to Reintroduce Susvimo Ocular Implant for Wet AMD
Genentech announced the reintroduction of Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant, aimed at treating wet age-related macular degeneration (AMD). This decision follows the FDA's approval of a post-approval supplement to the Biologics License Application, which incorporates updates to the ocular implant and refill needle components.
Commitment to Retina Specialists and Patients
The company plans to make Susvimo available to retina specialists and their patients in the United States in the coming weeks. Dr. Levi Garraway, Genentech's Chief Medical Officer and Head of Global Product Development, expressed enthusiasm about Susvimo's return, emphasizing its potential to offer an effective alternative to frequent eye injections.
"We are pleased to reintroduce Susvimo, a unique therapeutic approach shown to provide an effective alternative to regular eye injections by preserving vision with two refills per year in phase 3 study patients with wet AMD," said Dr. Garraway in a company news release. "Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements."
Mechanism and Refinement
Susvimo operates by delivering a customized formulation of ranibizumab continuously through the Port Delivery Platform. The implant is surgically inserted into the eye during a one-time outpatient procedure and requires refilling every six months using a specialized needle.
Addressing Past Challenges
Initially approved by the FDA in 2021, Susvimo was subject to a voluntary recall in October 2022. The recall encompassed the ocular implant, insertion tool, and initial fill kit in the US, prompted by findings that some implants did not meet performance standards during reliability testing. Bill Anderson, CEO of Roche (Genentech's parent company), discussed the issue during an investor call, highlighting concerns about the reliability of the septum in the port delivery device.
"We noticed in our laboratory testing—reliability testing—that in certain cases, the septum, which is the seal on the port delivery device that prevents the medicine from leaking out once it's been injected in, that seal could fail after repeated dosing," Anderson explained at the time.
Enhancements and Reliability
Genentech has since updated the implant and refill needle, ensuring they meet rigorous performance standards following extensive testing. The company also implemented improvements in its manufacturing processes to enhance reliability.
The reintroduction of Susvimo underscores Genentech's commitment to advancing retinal treatments and addressing the needs of patients with wet AMD. With the updated product now set for distribution, the company aims to restore confidence among healthcare providers and patients alike in its innovative ocular treatment options.
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