No additional treatment is needed! RHHBY.US's innovative treatment has been accepted by the FDA for marketing approval.
On July 19, R&D Holding Co., Ltd. (RHHBY.US) announced positive data from the Phase 3 clinical trials, Pagoda and Pavilion, evaluating the efficacy of its ranibizumab anti-VEGF drug delivery system, Susvimo, for the treatment of diabetic macular edema (DME) and diabetic retinopathy (DR). The analysis showed that both Phase 3 trials met their primary endpoint. In the Pavilion study, 0% of DR patients treated with monthly injections of Susvimo needed additional treatment, compared to 60% in the control group. The U.S. FDA has accepted R&D's resubmission of Susvimo for the treatment of DME and DR.
It is estimated that diabetic macular edema (DME) and diabetic retinopathy (DR) are the two leading causes of vision loss in adults with diabetes. DME is caused by leakage of fluid into the macula due to damaged blood vessels. The macula is the central part of the retina, responsible for the clear vision needed for reading and driving, and affects an estimated 29 million people worldwide. DME is usually treated with regular injections of a standard eye drop every one to four months.
Susvimo is a re-fillable eye implant that can be implanted in a single clinic visit. Susvimo delivers a personalized ranibizumab anti-VEGF formulation over time. Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind and inhibit VEGF-A, a protein that has been shown to play a critical role in neovascularization and vascular leakage.
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