Roche to Relaunch Eye Implant Susvimo After 2-Year Recall

Roche's eye implant, Susvimo, designed to offer continuous dosing of Lucentis, faced a market suspension in 2022 due to manufacturing issues. The implant, which requires only two refills annually, provides an alternative to frequent eye injections for treating wet age-related macular degeneration (AMD). In October 2022, Genentech and its parent company Roche withdrew Susvimo from the market after discovering that some implants did not meet their standards.

After addressing these issues and making FDA-approved updates to the implant and refill needle, Roche is set to reintroduce Susvimo. The company's chief medical officer, Levi Garraway, emphasized their commitment to innovative retinal treatments and suggested that Susvimo's return could pave the way for future advancements in the field. Roche plans to make the therapy available within the next few weeks.

Initially approved in 2021, Susvimo offers continuous delivery of ranibizumab, the active ingredient in Lucentis, through surgical insertion. In its first year on the market, Susvimo began to gain traction. Analysts at Spherix found that a majority of ophthalmologists recognized the therapy's longer-lasting effects compared to Eylea, a leading treatment from Regeneron and Bayer.

Despite these advantages, many doctors viewed Eylea as a safer and more accessible option. As one of the top-selling drugs with various indications for eye diseases, Eylea poses a significant challenge for new entrants like Susvimo. In response, Genentech is not only reintroducing Susvimo but also promoting its newer drug, Vabysmo, launched in 2022.

Since the introduction of Vabysmo, Eylea has experienced a decline in sales for the first time, while Vabysmo continues to grow. Regeneron and Bayer have attempted to counteract this by releasing a high-dose formulation of Eylea last year. Meanwhile, Vabysmo recently gained FDA approval for a prefilled syringe version, offering doctors a more convenient, ready-to-use option.

Additionally, Genentech is developing a new treatment for wet AMD designed to be compatible with the Susvimo delivery system. This new molecule is currently in the early stages of development, demonstrating Genentech's ongoing efforts to innovate in the ophthalmology space.