Within a year of reintroducing the eye implant Susvimo, Roche received approval from the US Food and Drug Administration (FDA) to expand its label to treat diabetic macular edema (DME).
The Swiss pharmaceutical giant ended the voluntary recall of Susvimo in July 2024. As part of the reintroduction, Roche updated the ocular implant and refilled the needle. The company issued a voluntary recall of the Susvimo implant in October 2022 after an investigation into septum dislodgement cases in a Phase III trial.
The US regulator first approved Susvimo as a third-line treatment for wet/neovascular, age-related macular degeneration (AMD) in 2021. The implant is surgically inserted into the eye during a one-time, outpatient procedure. It is refilled once every six months using a specifically designed needle, which introduces a customized formulation of ranibizumab directly into the device.
The ranibizumab intravitreal injections are marketed as Lucentis in the US. As Lucentis, the therapy is approved to treat wet AMD, DME, diabetic retinopathy, and myopic choroidal neovascularization. Lucentis sales have declined in recent months, pulling in CHF144 million ($159 million) in sales last year, compared to CHF460 million ($508 million) in 2023. Roche attributed the decline to a switch to its other medication Vabysmo (faricimab-svoa) and “competitive pressure”, including the introduction of biosimilars.
Phase III trial data
Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that plays a critical role in the formation of new blood vessels and the leakiness of the vessels.
The FDA approval was based on the positive data from the Phase III Pagoda trial (NCT04108156). The study compared the efficacy of Susvimo with 4 weekly Lucentis injections in 634 patients with DME. The patients in the Susvimo group reported non-inferior improvements in vision compared with those receiving monthly Lucentis injections, improving by 9.6 eye chart letters with Susvimo versus 9.4 letters with Lucentis.
Susvimo carries a warning for endophthalmitis, a bacterial or fungal infection of the eye that can lead to blindness. The implant is associated with an up to three-fold higher rate of endophthalmitis than monthly intravitreal injections of Lucentis.
Roche is also developing a bispecific antibody treatment, DutaFabs, designed for “increased efficacy and durability – tailored for continuous delivery via the Port Delivery implant”.
