The expanded approval of Lucentis 0.3 mg has been announced by the US Food and Drug Administration (FDA) to treat diabetic retinopathy in patients with diabetic macular edema.
What is Lucentis?
Lucentis (ranibizumab injection) is administered once a month into the eye by a physician. It is used alongside appropriate interventions to help control cholesterol, blood sugar and blood pressure.
Lucentis, developed by Swiss pharmaceutical company Roche, has previously been approved to treat diabetic macular edema – which affects central vision, and requires injections to prevent abnormal blood vessels developing.
It was used to treat diabetic macular edema secondary to retinal vein occlusions and neovascular age-related macular degeneration.
FDA approval
Breakthrough therapy designation has been awarded to Lucentis for diabetic retinopathy with diabetic macular edema after its safety and efficacy were reviewed by the FDA.
Two clinical studies (RISE and RIDE Phase III) involving 759 patients with diabetic retinopathy were treated with Lucentis and followed for three days. The severity of their diabetic retinopathy was significantly improved compared to those who didn’t receive the injection.
“Diabetes is a serious public health crisis, affecting more patients every year. Today’s approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Centre for Drug Evaluation and Research.

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