FDA Approves Roche’s Susvimo for Diabetic Macular Edema: A Breakthrough in Continuous Delivery Eye Treatment
The FDA approved Roche's Susvimo (ranibizumab injection) for the treatment of diabetic macular edema (DME) on February 4, 202523.
Susvimo is the first and only FDA-approved continuous delivery treatment for DME that requires fewer treatments than standard eye injections23.
The approval is based on positive one-year results from the Phase III Pagoda study, which showed non-inferior vision improvements compared to monthly injections25.
Susvimo can be administered as few as two times per year, offering a convenient alternative to regular eye injections23.
The treatment uses the Port Delivery Platform to provide continuous delivery of a customized formulation of ranibizumab27.
This marks the second indication for Susvimo, which was first approved for wet age-related macular degeneration (AMD) in 202123.
In clinical trials, approximately 95% of patients treated with Susvimo did not need additional treatment with supplemental injections during the 64-week primary analysis period5.
Susvimo is now available to U.S. retina specialists and their patients with DME23.
The global prevalence of DME affects more than 29 million adults worldwide23.
Roche reintroduced Susvimo in July 2024 after addressing manufacturing concerns that led to a market withdrawal in 202249.
Sources:
2. https://www.gene.com/media/press-releases/15050/2025-02-04/fda-approves-genentechs-susvimo-as-the-f
3. https://www.biospace.com/press-releases/fda-approves-roches-susvimo-as-the-first-and-only-continuous-delivery-treatment-for-the-leading-cause-of-diabetes-related-blindness
4. https://www.fiercepharma.com/pharma/roches-eye-implant-med-susvimo-can-return-shelves-fdas-blessing
5. https://www.managedhealthcareexecutive.com/view/fda-approves-susvimo-for-diabetic-macular-edema
7. https://www.pharmexec.com/view/fda-roche-susvimo-refillable-eye-implant-diabetic-macular-edema
9. https://www.worldpharmaceuticals.net/news/fda-approves-roches-susvimo-for-diabetic-macular-oedema/