The FDA approved a post-approval supplement to Susvimo’s Biologics License Application (BLA). Approval reflects component-level updates made to the ocular implant and refill needle. Roche now plans to work to make Susvimo available in the U.S. to retina specialists and patients in the coming weeks.
Susvimo provides continuous delivery of a customized formulation of ranibizumab through the Port delivery platform. Roche designed it to treat neovascular (or wet) age-related macular degeneration (nAMD). It potentially improves upon the currently approved treatments that may require multiple eye injections per year.
Patients receive the implant in their eye during a one-time, outpatient procedure. Refills occur once every six months using a specifically designed needle that introduces the therapeutic directly into the device. Susvimo originally received FDA approval in 2021, but Roche voluntarily recalled the therapy the following year.
Roche recalled the implant, insertion tool and initial fill kit in the U.S. after results showed that some implants “did not perform to Roche’s standards.” The updated system now meets those standards, the company says, while it also implemented manufacturing process improvements.
“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 neovascular age-related macular degeneration,” said Dr. Levi Garraway, Roche chief medical officer and head of global product development. “Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements.”
