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
Plant-Based Diet Protects Against Multiple Chronic Illnesses
FRIDAY, Aug. 29, 2025 — Shifting to a plant-based diet can help keep people from being plagued by multiple health problems as they age, a new study says. People whose diets...
New GLP-1 Pill, Orforglipron, Helps People Lose 23 Pounds in Study
WEDNESDAY, Aug. 27, 2025 — Eli Lilly says its new once-daily pill, orforglipron, helped people lose significant weight and lower blood sugar in a late-stage clinical...
Breath Test For Diabetes Under Development
WEDNESDAY, Aug. 27, 2025 — Detecting diabetes might soon be as easy as breathing into a device, a new study says. An experimental breath test sorted out type 2 diabetes...
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.