FDA Approves Roche’s Susvimo as the First and Only Continuous-Delivery Treatment for Diabetic Retinopathy, Offering Nine-Month Dosing Durability
In a significant advancement for patients suffering from diabetic retinopathy (DR), the U.S. Food and Drug Administration (FDA) has approved Susvimo® (ranibizumab injection) 100 mg/mL, developed by Roche, as a new treatment option for this progressive, potentially blinding eye condition. The regulatory milestone marks Susvimo as the first and only FDA-approved continuous intraocular drug delivery system that maintains vision with just a single refill every nine months. This approval has the potential to transform how DR is managed for millions of patients in the United States and globally.
Addressing a Global Epidemic of Diabetic Eye Disease
Diabetic retinopathy remains one of the most serious complications of diabetes, a chronic disease that affects blood sugar regulation. In the U.S. alone, approximately 10 million people are living with diabetic retinopathy. Globally, more than 100 million individuals are estimated to be affected by this condition, which develops as prolonged high blood sugar levels damage the small blood vessels in the retina—the light-sensitive tissue at the back of the eye.
Left untreated or inadequately managed, DR can lead to severe visual impairment or even complete blindness. As the number of people living with diabetes continues to rise, particularly in aging populations and low- and middle-income countries, the need for durable, effective, and patient-friendly treatments has become increasingly urgent.
A New Era in Retinal Disease Treatment
Susvimo is a novel approach to treating diabetic retinopathy. Unlike conventional therapies that often require monthly intravitreal injections, Susvimo utilizes a Port Delivery Platform, which is a surgically implanted, refillable reservoir that delivers a customized formulation of ranibizumab—a well-established anti-vascular endothelial growth factor (anti-VEGF) therapy—directly into the eye. This device enables continuous drug delivery over extended periods, reducing the treatment burden on both patients and healthcare providers.
The FDA’s decision is specifically indicated for patients with diabetic retinopathy who have previously responded to at least two anti-VEGF injections. Susvimo will now be available across the U.S. through retina specialists equipped to offer this advanced therapy.
“This approval marks an important milestone in the treatment landscape for diabetic retinopathy,” said Dr. Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche. “With Susvimo, patients can experience predictable and immediate durability after the initial implantation, potentially going nine months between treatments. This could offer substantial relief to patients who currently require frequent office visits and eye injections.”
Garraway emphasized the significance of this reduced treatment frequency, particularly for people with diabetes who often manage multiple comorbidities and complex care routines. “Many patients with common retinal conditions seek alternative treatment options like Susvimo that can help preserve vision with longer intervals between treatments,” he added.
Strong Clinical Evidence from the Phase III Pavilion Study
The FDA approval was primarily based on the robust clinical data from the Phase III Pavilion study, which evaluated the efficacy and safety of Susvimo in patients with diabetic retinopathy. Over the course of one year, the study demonstrated that participants who received Susvimo, refilled every nine months, achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared to those under observation who received anti-VEGF injections only when disease progression was evident.
In essence, the DRSS improvements reflected a reduction in the severity of the retinal damage caused by diabetes, signaling that Susvimo not only stabilizes but potentially halts disease progression more effectively than reactive, as-needed treatment regimens.
Notably, none of the participants treated with Susvimo required supplemental therapy during the 12-month evaluation period. This result reinforces the implant’s ability to sustain therapeutic concentrations of the drug without the need for additional interventions.
The safety profile observed in the Pavilion trial was consistent with previous studies on Susvimo and with the known safety profile of ranibizumab. While the procedure involves a surgical implantation, no unexpected safety concerns emerged, underscoring its potential as a long-term solution for appropriate patients.
Endorsement from the Retina Specialist Community
The announcement of Susvimo’s approval has been met with enthusiasm from the ophthalmology community, particularly among retina specialists seeking more durable options for patients who struggle to keep up with intensive treatment schedules.
“Susvimo is a compelling new treatment for patients at risk of vision loss from progression of diabetic retinopathy,” said Dr. Carl Awh, a leading vitreoretinal surgeon at Tennessee Retina. “I am delighted to have this far more durable treatment available for my patients.”
Awh noted that the Port Delivery Platform not only improves clinical outcomes but may also enhance quality of life by minimizing the physical and emotional burden associated with repeated eye injections. This is especially important for patients who may already face significant challenges in managing their diabetes.
Transformative Technology: The Port Delivery Platform
At the heart of Susvimo’s innovation lies the Port Delivery Platform, a refillable ocular implant that offers a paradigm shift in the management of chronic retinal diseases. Inserted during a one-time, outpatient surgical procedure, the implant is designed to reside in the eye long-term and is refilled every nine months with a customized formulation of ranibizumab.
This approach introduces the medication directly into the vitreous humor, allowing for continuous intraocular diffusion and consistent therapeutic levels. Traditional anti-VEGF therapies, in contrast, require frequent bolus injections—often once a month—creating a significant treatment burden for patients, caregivers, and clinics.
With its extended duration of action, Susvimo aims to reduce treatment fatigue, improve adherence, and maintain better long-term visual outcomes. In real-world practice, many patients struggle to comply with monthly injection regimens, resulting in suboptimal results. Susvimo’s design seeks to bridge this gap.
Roche’s Expanding Commitment to Ophthalmology
The approval of Susvimo for diabetic retinopathy represents the latest chapter in Roche’s growing commitment to innovative eye care therapies. As a company deeply invested in combating leading causes of vision loss, Roche is leveraging its scientific expertise and patient-centered approach to develop a broad portfolio of retinal disease treatments.
“With Susvimo, we are expanding access to transformative therapies that can preserve vision and ease the treatment journey,” said Dr. Garraway. “We are continuing to listen to patients, caregivers, and physicians to ensure we bring forward solutions that make a real difference in people’s lives.”
Roche currently boasts the broadest retina pipeline in ophthalmology, spanning multiple indications and treatment modalities. The pipeline is guided by a strategic vision to address not only existing needs but also to prepare for future challenges posed by rising disease prevalence and evolving patient demographics.
With the FDA’s green light, Roche’s Susvimo becomes a pioneering tool in the ongoing battle against diabetic retinopathy, offering a combination of efficacy, safety, and convenience that may reshape clinical practice. For patients facing the anxiety of vision loss and the challenge of monthly injections, the ability to rely on a durable treatment every nine months brings both hope and freedom.
As retina specialists begin to incorporate this new therapy into their practices, the true impact of Susvimo will be seen in the preservation of sight and quality of life for thousands—potentially millions—of people managing this common yet devastating complication of diabetes.
