SHERIDAN, WYOMING – May 27, 2025 – Roche has received FDA approval for Susvimo® (ranibizumab injection) 100 mg/mL as a new treatment for diabetic retinopathy (DR), marking a pivotal advancement in the battle against this vision-threatening condition that affects nearly 10 million Americans.
The approval makes Susvimo the first and only FDA-approved continuous drug delivery system for DR, offering patients the potential to maintain vision with just one refill every nine months. This development adds a third approved indication for Susvimo, which is already cleared for neovascular or ‘wet’ age-related macular degeneration and diabetic macular edema.
A transformative solution for millions at risk
Susvimo leverages Roche’s proprietary Port Delivery Platform, a refillable eye implant that continuously releases a customized formulation of ranibizumab. Unlike traditional treatments that may require monthly intravitreal injections, Susvimo’s sustained delivery model aims to alleviate treatment burden while maintaining visual outcomes.
“The approval of Susvimo for diabetic retinopathy expands treatment options for patients, offering predictable and immediate durability after implantation with only one treatment every nine months,” said Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development. “Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments than regular eye injections.”
Vitreoretinal surgeon Carl Awh, M.D., Tennessee Retina, added, “Susvimo is a compelling new treatment for patients at risk of vision loss from progression of diabetic retinopathy. I am delighted to have this far more durable treatment available for my patients.”
Strong clinical data supports long-term efficacy
The FDA’s decision is based on results from the phase III Pavilion study, which showed superior outcomes on the Diabetic Retinopathy Severity Scale (DRSS) in patients treated with Susvimo versus those receiving anti-VEGF injections on an as-needed basis.
Key highlights from the study include:
- All patients in the Susvimo group achieved significant improvements in DR severity.
- No participant required supplemental treatment at one year.
- Safety profile remained consistent with previous Susvimo trials.
This data underscores Susvimo’s clinical potential to prevent progression to blindness while reducing the frequency of treatment interventions.
Addressing a global challenge in eye care
Diabetic retinopathy remains a leading cause of vision impairment, affecting over 100 million people globally and resulting in blindness in approximately 5 million cases. By minimizing the treatment burden, Susvimo supports better adherence and potentially improved outcomes across diverse patient populations.
The Port Delivery Platform enables direct, controlled drug delivery through a single outpatient procedure. Once implanted, Susvimo steadily administers ranibizumab, a VEGF inhibitor that suppresses abnormal blood vessel growth and fluid leakage—hallmarks of DR and other retinal diseases.
Strategic fit within Roche’s ophthalmology leadership
The launch aligns with Roche’s broader vision of transforming ophthalmic care through scientific innovation. With the most extensive retina pipeline in the industry, Roche is advancing personalized and durable treatments across several eye conditions, including:
- Susvimo for DR, DME, and wet AMD
- Vabysmo®, the first bispecific antibody for the eye
- DutaFabs, next-generation bispecific antibodies designed for continuous delivery
Roche continues to combine molecular engineering and delivery innovation to address unmet needs in retinal medicine. Its commitment to ophthalmology is grounded in deep patient insights and a forward-thinking approach to therapy development.
Advancing sustainable innovation in healthcare
Founded in Basel in 1896, Roche remains at the forefront of global healthcare, driving breakthroughs across pharmaceuticals and diagnostics. The company’s ophthalmology portfolio is a testament to its mission of improving quality of life through targeted, high-impact interventions.
Learn more about Susvimo and Roche’s ophthalmology innovations at www.roche.com.