Roche has received US Food and Drug Administration (FDA) approval for Susvimo (ranibizumab injection) for treating diabetic macular oedema (DME).
Susvimo is said to be the first and only FDA-approved treatment for DME that requires fewer injections than standard eye injections. It helps maintain vision for people with the condition.
The therapy, a refillable eye implant, is now available to retina specialists and patients in the US. It is surgically inserted into the eye through a one-time, outpatient procedure.
The ranibizumab injection delivers a customised formulation of ranibizumab through the Port Delivery Platform, offering continuous treatment.
First approved by the FDA in 2021 for treating neovascular, age-related macular degeneration (nAMD), Susvimo is now being discussed with other global regulatory agencies.
In July 2024, the Swiss firm reintroduced the therapy after it was recalled from the market in 2022 over manufacturing issues.
Roche chief medical officer and global product development head Levi Garraway said: “Susvimo presents a unique, convenient treatment alternative to routine eye injections for people with a potentially blinding diabetic eye condition.
“As the global prevalence of diabetic macular oedema continues to grow, today’s FDA approval for Susvimo reflects our dedication to innovation and enhancing the patient experience.”
The FDA approval was based on positive one-year results from the Phase 3 Pagoda study.
It assessed the efficacy, safety and pharmacokinetics of Susvimo refilled every six months compared with monthly ranibizumab 0.5 mg intravitreal injections in 634 people with DME.
According to the findings, Susvimo provided sustained vision improvements for people with DME, with safety consistent with its known profile.
Patients receiving the drug every six months saw non-inferior improvements in vision comparable to those receiving monthly 0.5 mg ranibizumab injections.
Both groups showed improvements of about 9.6 and 9.4 eye chart letters, respectively, like gaining two more lines on an eye chart.
The ranibizumab formulation delivered by Susvimo is different from Lucentis (ranibizumab injection), which is approved for treating nAMD and other retinal diseases.
Lucentis was first approved by the FDA for nAMD in 2006.
Roche is also developing DutaFabs, a next-generation bispecific antibody designed for improved efficacy and durability. It is tailored for continuous delivery through the Port Delivery implant.
The Swiss firm’s ophthalmology portfolio also targets retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular oedema.
