The FDA approved Susvimo (ranibizumab injection) for diabetic macular edema (DME), a leading cause of vision loss. This marks the second indication for Susvimo, following its 2021 approval for wet age-related macular degeneration (AMD). The approval is based on the Phase III Pagoda study, which demonstrated Susvimo’s ability to maintain vision improvements in DME patients with a safety profile consistent with prior findings.
This approval significantly benefits DME patients, who previously faced frequent, often monthly, eye injections. Susvimo offers a less disruptive treatment option with refills required only twice a year, potentially improving patient adherence and quality of life. This also frees up valuable physician and clinic resources, enabling them to treat a greater number of patients. The expansion of Susvimo’s indication broadens its market reach, offering a significant advancement in DME treatment.
The Pagoda study showed Susvimo achieved non-inferior vision improvements compared to monthly ranibizumab injections. Specifically, patients receiving Susvimo every six months gained an average of 9.6 letters on an eye chart, comparable to the 9.4 letters gained by those receiving monthly injections. The implant delivers a customized ranibizumab formulation via the Port Delivery Platform, enabling continuous treatment. Genentech is providing support services to assist patients with access and reimbursement.
This FDA approval positions Susvimo as a leading treatment option for DME, potentially transforming the standard of care. The twice-yearly treatment regimen offers significant advantages for both patients and healthcare providers. This approval also reinforces Genentech’s commitment to ophthalmology and its continued development of innovative drug delivery systems for retinal diseases. Further research and real-world data will be crucial in fully assessing Susvimo’s long-term efficacy and impact on DME management.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
