Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), have announced the reintroduction of “Susvimo” (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people in the United States with wet, or neovascular, age-related macular degeneration (AMD). The Food and Drug Administration (FDA) approved a post-approval supplement to the Biologics License Application for Susvimo, “reflecting component-level updates made to the ocular implant and refill needle”.
According to the company, the Susvimo implant, the size of a grain of rice, is surgically inserted into the eye during a one-time, outpatient procedure and is refilled once every six months using a specifically designed needle, which introduces a customized formulation of ranibizumab directly into the device. Susvimo was approved by the FDA in 2021 however, the following year, Genentech voluntarily recalled the ocular implant, insertion tool and initial fill kit in the U.S. following test results that showed some implants did not perform to Genentech’s standards. Genentech has since updated the Susvimo implant and refill needle, and testing confirmed that they now meet these performance standards. Previously, the US FDA has approved a 100 mg/mL ocular implant (“Port Delivery System” [PDS]) for the treatment of nAMD, tested in the “Archway” trial (NCT03677934), used a randomised, multicentre, open-label phase III study with a refillable anti-VEGF treatment (ranibizumab) allowing fixed intervals for every six-months. In follow-up to the Archway study, the implant may be refilled every six months at fixed intervals, compared to monthly intravitreal injections of ranibizumab (0.5 mg) with 415 participants with nAMD. The PDS is an implantable “reservoir-based, slow-release platform which sits in the sclera and delivers ranibizumab in a concentrated solution at different doses in the setting of nAMD”.
Following the recall, Genentech’s Senior Vice President and Global Head of Ophthalmology Product Development, Dr. Chris Brittain, explained that “some test results showed that the implants didn’t perform to our standards. Since then, we’ve spent the time updating the implant and the refill needle. And based on those updates, we conducted extensive testing again, just to confirm that they meet our performance standards. So that’s why we’re excited to bring it back. Patient safety is fundamental to us. So if any technology, be it a therapeutic or a device, doesn’t meet our standards, we make a very patient-focused decision. And this was absolutely the right thing, and it was something that we didn’t question.” Commenting on the announcement of the approval, Levi Garraway, M.D., Ph.D., Genentech’s Chief Medical Officer and Head of Global Product Development stated that, “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 III study patients with wet AMD. Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements.”