FDA Approves Susvimo for Diabetic Macular Edema
By Lori Solomon HealthDay Reporter
WEDNESDAY, Feb. 5, 2025 -- The U.S. Food and Drug Administration has approved Susvimo (ranibizumab) 100 mg/mL for treating diabetic macular edema.
Susvimo is the first and only FDA-approved treatment shown to maintain vision in people with diabetic macular edema with fewer treatments based on its continuous delivery of a customized formulation of ranibizumab via the Port Delivery Platform. The refillable implant is surgically inserted into the eye during a one-time, outpatient procedure.
The approval was based on positive one-year results from the phase 3 Pagoda study. In the trial, people with diabetic macular edema who received Susvimo refilled every six months achieved noninferior improvements in vision compared with those receiving monthly 0.5-mg ranibizumab intravitreal injections (9.6 and 9.4 eye chart letters, respectively). The most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure, while the most common nonocular side effects included nasopharyngitis, anemia, nausea, and cough.
"I am excited to offer Susvimo to my patients living with diabetic macular edema who want an option with longer intervals between treatments due to their busy personal and professional lives," Jordan Graff, M.D., from the Barnet Dulaney Perkins Eye Center in Phoenix, said in a statement. "Having completed dozens of Susvimo surgeries in my patients with wet, or neovascular, age-related macular degeneration, I've seen firsthand how Susvimo, with its continuous delivery of medication, can help preserve vision with fewer treatments. I look forward to broadening Susvimo's impact to even more patients in my clinic."
Approval of Susvimo was granted to Genentech.
Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2025 HealthDay. All rights reserved.
Posted February 2025
Read this next
ENCELTO Implant Protects Against Vision-Destroying Eye Disease
MONDAY, Aug. 11, 2025 — A newly approved implant appears to slow vision loss from a rare and previously untreatable eye disease, researchers report. The eye implant, called...
New Weight Loss Pill From Eli Lilly, Orforglipron, Shows Promise in Early Study
FRIDAY, Aug. 8, 2025 — A new weight loss pill made by Eli Lilly helped people lose a significant amount of weight in a recent study. Taken at the highest dose, orforglipron...
1 in 10 Americans Has Used GLP-1 Drugs For Weight Loss, Survey Says
FRIDAY, Aug. 8, 2025 — More than 1 in 10 Americans have used a GLP-1 drug for weight loss, a new survey by the RAND research group reveals. About 12% say they’ve...
More news resources
- FDA Medwatch Drug Alerts
- Daily MedNews
- News for Health Professionals
- New Drug Approvals
- New Drug Applications
- Drug Shortages
- Clinical Trial Results
- Generic Drug Approvals
Subscribe to our newsletter
Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.