The U.S. Food and Drug Administration has approved Susvimo, a groundbreaking treatment for adults suffering from diabetic macular edema (DME). As the first implantable device to gradually release ranibizumab, a medicine for eye conditions, Susvimo represents a significant advancement in the treatment of this condition. Implanted during an outpatient procedure, the device delivers a consistent dose of ranibizumab directly to the eye, with each refill lasting up to six months.
Approval of Susvimo followed a comprehensive clinical trial involving 634 patients diagnosed with DME. The results demonstrated that the device could effectively maintain patients' vision with as few as two treatments per year. After one year, both the Susvimo group and the control group showed similar improvements in vision, highlighting the efficacy of this new treatment approach.
Ranibizumab, the active ingredient in Susvimo, plays a crucial role by reducing macular swelling. It achieves this by inhibiting VEGF-A, a protein responsible for the development of harmful blood vessels in the eye. This mechanism of action has been proven effective since ranibizumab injections (marketed as Lucentis) received approval in 2006.
While Susvimo offers an innovative solution, it is not without risks. The device carries a threefold increase in the risk of serious eye infections compared to monthly ranibizumab injections. Nevertheless, safety data from the trial align with previous findings, showing no new safety concerns. Furthermore, Susvimo represents its second approved use after initially receiving approval for wet age-related macular degeneration in 2021.
The refillable nature of the Susvimo device underscores its convenience, requiring only biannual visits for refills. However, users are advised to use birth control during treatment and for twelve months following their last refill.
Diabetic macular edema affects approximately 750,000 individuals in the United States and 29 million globally. With its innovative delivery method and demonstrated efficacy, Susvimo offers new hope to those managing this condition.
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