The FDA has approved Susvimo® (ranibizumab injection) 100 mg/mL for the treatment of diabetic macular edema (DME). Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with DME while requiring fewer treatments than standard-of-care eye injections.
DME is a leading cause of vision loss in adults with diabetes,1 and its prevalence is expected to rise as diabetes becomes more widespread.2
Susvimo is a refillable eye implant that continuously delivers a customized formulation of ranibizumab, a vascular endothelial growth factor (VEGF) inhibitor. The implant is surgically inserted in a one-time, outpatient procedure and can be refilled every six months, offering patients longer intervals between treatments.
The FDA’s decision was based on positive one-year results from the phase III Pagoda study (NCT04108156),3 a multicentre, randomised, active treatment-controlled, non-inferiority study of Susvimo refilled every six months compared with monthly ranibizumab 0.5 mg intravitreal injections, in 634 people with DME. Participants who received Susvimo refilled every six months achieved non-inferior improvements in vision compared to those receiving monthly 0.5 mg ranibizumab intravitreal injections. Specifically, patients treated with Susvimo gained an average of 9.6 letters on an eye chart, compared to 9.4 letters in the monthly injection group.4
This approval marks the second indication for Susvimo, which was first approved by the FDA in 2021 for the treatment of neovascular or ‘wet’ age-related macular degeneration (nAMD).5 Roche is currently in discussions with global regulatory agencies to expand Susvimo’s availability worldwide.
References:
1. Liu E, et al. DME: Clinical risk factors and emerging genetic influences. Clin Exp Optom. 2017;100:569–76.
2. Zhang J, ZhangJ, Zhang C, et al. Diabetic Macular Edema: Current Understanding, Molecular Mechanisms and Therapeutic Implications. Cells. 2022;11:3362. doi: 10.3390/cells11213362
3. Clinical Trials.gov. A study to evaluate the efficacy, safety and pharmacokinetics of the PDS with ranibizumab in participants with DME compared with intravitreal ranibizumab (Pagoda). Available from: https://clinicaltrials.gov/study/NCT04108156 (accessed 10 February 2025).
4. Khanani AM. Port Delivery System (PDS) with ranibizumab in patients with DME: Primary analysis results of the phase III Pagoda trial. Presented at: The Bascom Palmer Eye Institute Angiogenesis, Exudation, and Degeneration Annual Meeting; 2023 Feb 10-11; virtual.
5. FDA Approves Genentech’s Susvimo, a First-of-Its-Kind Therapeutic Approach for Wet Age-Related Macular Degeneration (AMD). Genentech Press Release. Available at: https://www.gene.com/media/press-releases/14935/2021-10-22/fda-approves-genentechs-susvimo-a-first- (accessed 10 February 2025).
Disclosures: This article was created by the touchOPHTHALMOLOGY team utilizing AI as an editorial tool (ChatGPT (GPT-4o) [Large language model]. https://chat.openai.com/chat.) The content was developed and edited by human editors. No funding was received in the publication of this article.:
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