¡New FDA approval (ranibizumab) in Diabetic Macular Edema (DME)
This drug already had prior approval for another ocular pathology
On February 4, 2025, it was announced that the FDA has approved Genentech (Roche Group)’s Susvimo (ranibizumab) as the first and only continuously administered treatment for diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes.
This condition affects more than 29 million people worldwide. Susvimo allows vision to be maintained with fewer treatments compared to conventional eye injections and is now available in the US for retina specialists and their patients.
Levi Garraway, Genentech’s chief medical officer, emphasized that Susvimo represents an innovative and convenient alternative to frequent injections, improving the patient experience. As the prevalence of DME continues to rise, this approval reinforces the company’s commitment to developing treatments that optimize eye care and reduce the burden of treatment for patients.
The FDA approval was based on the positive results of the Phase III Pagoda Study, which demonstrated sustained vision improvements in patients with DME. In this study, participants who received Susvimo refills every six months achieved visual improvements comparable to those receiving monthly ranibizumab injections. The gains in visual acuity were virtually identical in both groups, demonstrating the efficacy of the new treatment.
One of Susvimo’s key advantages is its ability to provide continuous drug delivery through the Port Delivery Platform, which differentiates it from other treatments that may require monthly injections. This technology allows for sustained drug release, maintaining adequate therapeutic levels over an extended period, reducing the need for frequent visits to the ophthalmologist. Susvimo was previously approved in 2021 for the treatment of neovascular age-related macular degeneration (AMD), supporting its safety and efficacy in chronic ophthalmic conditions.
