The U.S. Food and Drug Administration (FDA) has approved Susvimo (ranibizumab injection) 100 mg/mL to treat diabetic macular edema (DME), one of the leading causes of vision loss among individuals with diabetes. This approval marks a significant evolution in eye care as it requires fewer injections compared to existing treatments. Susvimo is now available to retina specialists and their patients across the United States.
DME affects approximately 750,000 U.S. people and 29 million cases worldwide. When retinal blood vessels become damaged, they leak fluid, leading to swelling in the macula, the region responsible for sharp central vision. The accumulation of fluid in the macula due to DME without proper treatment can cause blindness and significantly reduce quality of life. The increased number of diabetic patients leads to anticipated higher figures for DME cases.
Unlike traditional therapies that typically require multiple monthly injections, Susvimo utilizes a specialized ocular implant for sustained medication release. The implant is administered in a one-time outpatient procedure to the eye, and it is refilled every six months, thus reducing the number of injections. This offers significant assistance to those patients who have difficulties attending clinic visits regularly for the treatment.
The Pagoda study is a large clinical trial comparing two treatment approaches for diabetic macular edema. A total of 634 participants took part in this study to determine if Susvimo (for a six-month application) matches the performance of standard ranibizumab 0.5 mg intravitreal injections given monthly.
Participants were divided into two groups, one received Susvimo with six-month refills, while the other received monthly injections. All participants received four ranibizumab injections over 16 weeks before receiving the Susvimo implant.
The primary objective of the study is to evaluate vision alteration through letter reading tests conducted using patients’ maximal optical correction. Researchers conduct the eye chart reading test each at week 60 and week 64. Participants who received monthly injections during the first stage of the study transitioned to Susvimo therapy as they now needed medications refilled once every six months.
Ranibizumab, the active ingredient in Susvimo, works by inhibiting vascular endothelial growth factor (VEGF), a protein responsible for abnormal blood vessel growth and leakage in the retina. This inhibition reduces macular swelling and preserves vision in DME patients. The implant received its initial name as the Port Delivery System with ranibizumab.
The FDA first approved Susvimo for market release in 2021 to treat a severe eye condition known as wet age-related macular degeneration (AMD). The approval of Susvimo for DME extends the therapeutic options for people who face vision decline risks.
The head of Global Product Development and Chief Medical Officer, Dr. Levi Garraway, highlighted the significance of this approval, as Susvimo offers patients an easier route in managing DME challenges. Since more people continue to be diagnosed with diabetes worldwide, Susvimo represents one of the innovative solutions aimed at providing care for such patients and reducing the impact of repeated eye injections.
Susvimo represents a breakthrough for diabetic macular edema patients by offering fewer treatments to preserve vision.
Reference: Genentech. FDA Approves Genentech’s Susvimo as the First and Only Continuous Delivery Treatment for the Leading Cause of Diabetes-Related Blindness. Published February 4, 2025. Accessed February 7, 2025. Genentech: Press Releases | Tuesday, Feb 4, 2025
