Roche’s eye implant Susvimo for patients with neovascular age-related macular degeneration is re-entering the U.S. market after the FDA approved updates to the components of the product.
Roche on Monday announced that it will reintroduce Susvimo (ranibizumab injection) in the U.S., which will make the eye implant available again for the treatment of patients with neovascular age-related macular degeneration.
Susvimo’s re-entry into the U.S. market comes after its voluntary market recall, announced in October 2022. According to Roche, the FDA has signed off on a post-approval supplement to Susvimo’s Biological License Application, which reflects updates to the components of the ocular implant and its refill needle.
Roche expects to make Susvimo available in the U.S. “in the coming weeks.”
CMO Levi Garraway in a statement said that Roche is “pleased to reintroduce Susvimo” into the U.S. market, again making available a “unique therapeutic approach shown to provide an effective alternative to regular eye injections.”
First approved in October 2021, Susvimo is a refillable eye implant designed to deliver a specific formulation of ranibizumab over time. The implant is inserted into the eye during a one-time outpatient surgical procedure and requires a refill only once every six months.
At the time of its approval, Roche touted Susvimo as a “first-of-its-kind therapeutic approach” to neovascular age-related macular degeneration (AMD).
However, a year later, the company announced that it was voluntarily pulling Susvimo from U.S. shelves after documenting “septum dislodgement cases” that necessitated “additional testing of the commercial implant supply,” according to a letter sent to healthcare providers at the time. Testing showed that some implants “did not perform to our standards,” leading Roche to halt all new implantations and recall the product.
Susvimo’s reintroduction is expected to further strengthen Roche’s position in the ophthalmology space following its regulatory victory in October 2023, which expanded the label of its bispecific antibody Vabysmo (faricimab-svoa) to retinal vein occlusion. Vabysmo is also approved for the treatment of diabetic macular edema and wet AMD.
In the first quarter of 2024, Vabysmo was Roche’s strongest growth driver, with sales jumping 108% to $927.4 million.
Also seeking to establish its footing in the eye diseases space is Merck, which in May 2024 acquired private biotech EyeBio for up to $3 billion. The deal gives the pharma access to Restoret, an investigational and first-in-class investigational trispecific antibody for diabetic macular edema and wet AMD.
Merck previously exited the ophthalmology market in 2014 after it sold off its assets to Santen Pharmaceutical and Akorn Pharmaceuticals.
