United States: The US Food and Drug Administration (FDA) has authorized Susvimo (ranibizumab) 100 mg/mL as a treatment for diabetic macular edema.
More about the news
The combination of Susvimo and its specific ranibizumab formulation delivered through the Port Delivery System makes this treatment the initial FDA approval that provides continuous vision maintenance for diabetic macular edema patients using fewer doses, US News reported.
Medical staff perform a single outpatient surgical procedure to place the refillable implant directly inside the eye.
The FDA approved Susvimo through positive data collected from the Pagoda study, which lasted twelve months.
What does the study found?
People with diabetic macular edema who received Susvimo plus six-month refills showed vision improvements equal to patients who received monthly 0.5-mg ranibizumab intravitreal injections according to trial data (9.6 and 9.4 eye chart letters).
Consumers most often experienced conjunctival hemorrhage, eye pain, vitreous floaters, increased intraocular pressure in the eyes, nasopharyngitis, anemia, nausea, and cough outside the eyes.
Experts statement
According to Jordan Graff, M.D., from the Barnet Dulaney Perkins Eye Center in Phoenix, “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,” US News reported.
Moreover, “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,” Graff added.
The US Food and Drug Administration authorized market availability of Susvimo to Genentech.