Genentech, a member of the Roche Group (RO.SW)(ROG.VX)(RHHBY.PK), announced that the U.S. Food & Drug Administration or FDA approved Lucentis, or ranibizumab injection, for treatment of diabetic macular edema or DME, an eye condition in people with diabetes that causes blurred vision, severe vision loss and sometimes blindness.
Lucentis 0.5 mg once monthly was first approved by the FDA for treatment of wet age-related macular degeneration or AMD in 2006 and for macular edema following retinal vein occlusion or RVO in 2010.
Genentech said that Lucentis 0.3 mg once monthly was approved for DME, and physicians can order immediately with shipments expected to begin August 15.
Outside the U.S., Lucentis has received regulatory approval for treatment of visual impairment due to DME in more than 75 countries, for treatment of wet AMD in more than 100 countries and for treatment of RVO in more than 70 countries.
Lucentis 0.3 mg (0.05 mL of 6 mg/mL Lucentis solution) is recommended to be administered by intravitreal injection once a month (approximately 28 days) for treatment of diabetic macular edema or DME.
Diabetes is now the leading cause of new cases of blindness in American adults and DME is estimated to affect more than 560,000 Americans with the disease.
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by RTT Staff Writer
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