Roche Unveils Susvimo Comeback For AMD Treatment In The US

Basel, July 8, 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced the re-release of Susvimo® (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant in the United States. This reintroduction follows a voluntary recall and subsequent approval by the US Food and Drug Administration (FDA) of a post-approval supplement to the Biologics License Application. The updated ocular implant and refill needle components have been approved, paving the way for Roche to soon provide Susvimo to retina specialists and their patients suffering from neovascular or ‘wet’ age-related macular degeneration (nAMD) across the US.

Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development said, “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. Susvimo’s return to the retina community reflects our unwavering commitment to provide innovative retinal treatments, and lays the groundwork for future advancements.”

Susvimo offers a unique approach by continuously delivering a personalized formulation of ranibizumab through the Port Delivery Platform, contrasting with other approved treatments that often necessitate multiple annual eye injections. The Susvimo implant is placed into the eye via a single outpatient procedure and requires refilling every six months using a specially designed needle.

This procedure introduces a tailored ranibizumab formulation directly into the implant. FDA approval for Susvimo was secured in 2021. Following voluntary recall in the US the next year due to performance issues identified during testing, Roche has updated the Susvimo implant and refill needle to meet stringent performance standards. Manufacturing processes have also been refined. Roche remains dedicated to global accessibility of this advanced drug delivery system, part of its ongoing efforts to address the needs of individuals affected by nAMD and other common eye conditions like diabetic macular edema.