Genentech/Roche’s sustained release anti-VEGF eye implant provides a treatment option with reduced frequency for diabetic retinopathy.
Sustained release anti-VEGF is coming to diabetic retinopathy (DR).
Genentech has announced that the U.S. Food and Drug Administration (FDA) has approved Genentech’s (California, United States) Susvimo (ranibizumab injection) for the treatment of diabetic retinopathy (DR), providing patients with a continuous delivery treatment option requiring refills potentially only once every nine months, the company announced on Wednesday.
Susvimo, developed by Genentech, a member of the Roche Group (Basel, Switzerland), is the first FDA-approved continuous delivery treatment for DR. The treatment works through a refillable eye implant surgically inserted during a one-time outpatient procedure.
The approach represents a much-anticipated change from current treatments that require frequent eye injections and the associated burden of treatment.
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“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 Dr. Levi Garraway, chief medical officer and head of Global Product Development at Genentech.
“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.”
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The treatment is now available to U.S. retina specialists and their patients with DR who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
This marks the third FDA-approved indication for Susvimo, which is also approved for treating wet age-related macular degeneration and diabetic macular edema.
Dr. Arshad Khanani (USA) comments on Susvimo’s FDA approval and impact.
The sustained anti-VEGF delivery system powering Susvimo
The Susvimo system utilizes the proprietary Port Delivery Platform, which delivers a customized formulation of ranibizumab directly into the eye.
The implant is surgically inserted into the eye during an outpatient procedure. Once in place, it continuously delivers the medication, eliminating the need for monthly injections that are common with traditional treatments.
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Crucially, the implant requires refilling only once every nine months—a stark contrast to current injection-based treatments, which can require monthly treatments to the ophthalmologist.
Genentech notes that it is also developing next-generation bispecific antibodies designed for increased efficacy and durability, tailored for continuous delivery via the Port Delivery implant.
Pavilion study findings
The FDA approval was based on one-year results from the Phase III Pavilion study involving 174 people with diabetic retinopathy without center-involved diabetic macular edema. The multicenter, randomized, U.S.-based study evaluated the efficacy, safety and pharmacokinetics of Susvimo compared with people under monthly clinical observation.
Key takeaways from the Pavilion study:
- Patients receiving Susvimo achieved superior improvements on the Diabetic Retinopathy Severity Scale (DRSS) compared to those under monthly observation
- The improvements indicated a reduction in the severity of eye damage caused by diabetes
- None of the Susvimo recipients required supplemental treatment during the one-year study period
- Participants in the Susvimo arm received two loading doses of intravitreal ranibizumab before Susvimo implantation at week 4
- Participants were randomized 5:3 to receive either Susvimo with refills every nine months or monthly clinical observation
- The safety profile was consistent with previous findings for Susvimo
“Susvimo is a compelling new treatment for patients at risk of vision loss from progression of diabetic retinopathy,” said vitreoretinal surgeon Carl Awh, MD, of Tennessee Retina. “I am delighted to have this far more durable treatment available for my patients.”
Clinical implications for diabetic retinopathy management
The addition of Susvimo to the treatment armamentarium for diabetic retinopathy provides clinicians with an option that may improve treatment adherence by reducing the frequency of interventions.
For patients who have demonstrated a response to anti-VEGF therapy but struggle with the burden of frequent injections, this continuous delivery system may represent a valuable alternative.
Editor’s note: For more information, see Genentech’s press release and the clinicaltrials.gov home of the Pavilion study.
