Susvimo® (ranibizumab injection) has become the first FDA-approved continuous delivery system for diabetic retinopathy (DR), reducing treatment frequency to once every nine months.1 The approval is based on the positive results of the phase III Pavilion study, showing significant improvement in disease severity.
DR is a major cause of vision loss, affecting nearly 10 million Americans and over 100 million people globally.2 It develops when high blood sugar damages the tiny blood vessels in the retina, potentially leading to vision impairment or blindness. DR often progresses silently and can eventually cause diabetic macular edema (DME), a severe complication that can further impair vision.
The FDA’s decision to approve Susvimo (ranibizumab injection) 100 mg/mL was supported by one-year data from the phase III Pavilion study (NCT04503551). In this trial, 174 patients with DR (but without center-involved DME) were randomized to receive either Susvimo every nine months or standard clinical observation with treatment as needed. Participants in the Susvimo group showed superior improvement in retinal damage as measured by the Diabetic Retinopathy Severity Scale, with no need for supplemental treatment over the course of a year. Safety results aligned with the known profile of Susvimo.
Susvimo is delivered through the Port Delivery Platform, a refillable eye implant inserted via outpatient surgery. This device continuously administers ranibizumab into the eye, offering a long-lasting alternative to monthly anti-VEGF eye injections.
References
1. FDA approves Genentech’s Susvimo for diabetic retinopathy. Genentech website. Available at: https://www.gene.com/media/press-releases/15062/2025-05-22/fda-approves-genentechs-susvimo-for-diab (accessed 23 May 2025).
2. VEHSS Modeled Estimates: Prevalence of Diabetic Retinopathy (DR). CDC.gov. Available at: https://www.cdc.gov/vision-health-data/prevalence-estimates/dr-prevalence.html? (accessed 23 May 2025).
Disclosures: This article was created by the touchOPHTHALMOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.
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