FDA Approves Roche's Susvimo for Diabetic Retinopathy, Reducing Injection Frequency by 80%
1min read Roche, a leading pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo (ranibizumab) 100 mg/mL for the treatment of diabetic retinopathy (DR). This approval is a significant development as Susvimo is the first FDA-approved drug that can be administered through a sustained-release mechanism, requiring only one injection every nine months. This innovative approach is designed to improve patient compliance and reduce the burden of frequent clinic visits, which are typically required for traditional treatments.
The approval of Susvimo is based on the positive results from the Pavilion Phase 3 clinical trial, which evaluated the efficacy, safety, and pharmacokinetics of Susvimo compared to monthly clinical monitoring and pro re nata (PRN) anti-VEGF injections. The trial involved 174 patients with non-proliferative diabetic retinopathy without center-involved diabetic macular edema, who were randomly assigned in a 5:3 ratio to receive either Susvimo every nine months or monthly clinical observation. The results showed that patients treated with Susvimo every nine months experienced significant improvements in the Diabetic Retinopathy Severity Scale (DRSS) score, indicating less severe eye damage due to diabetes compared to the control group. Additionally, no patients in the Susvimo treatment group required additional supportive therapy within the one-year study period. The safety profile of Susvimo was consistent with its known safety characteristics.
This approval is particularly significant for patients who struggle with the logistical and emotional challenges of managing chronic conditions. The ability to receive treatment less frequently can alleviate the stress and inconvenience associated with regular clinic visits, allowing patients to focus more on their overall health and well-being. Additionally, the reduced need for frequent injections can lower the risk of complications and infections, further enhancing patient safety.
Susvimo represents a major advancement in the treatment of diabetic retinopathy, offering a more convenient and effective option for patients. The approval underscores Roche's leadership in developing innovative therapies that address unmet medical needs. As the prevalence of diabetes continues to rise, the availability of Susvimo will provide a much-needed solution for managing one of its most debilitating complications. This development is expected to improve the quality of life for patients with diabetic retinopathy, providing them with a more sustainable and effective treatment option.
