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Lucentis, the 0.3-mg dose of ranibizumab injection, has been approved by the FDA for treatment of diabetic macular edema (DME).
In last week's Ophthalmology Times eReport (August 1, 2012), we reported that an FDA advisory committee unanimously recommended approval of the 0.3-mg dose of ranibizumab injection (Lucentis, Genentech) for the treatment of diabetic macular edema (DME). Just today (Friday, August 10, 2012), the FDA approved Lucentis for the treatment of DME.
The approval of Lucentis comes after successful cinlical trials from the RISE/RIDE studies. Highlights of the studies include
Prior to Lucentis, the standard care given for DME has been laser surgery. Laser surgery has displayed the ability to slow vision loss and stabilize vision, but not recover the vision lost in DME patients. Hal Barron, MD, chief medical officer and head of Global Product Development commented on the approval on Lucentis,
“For the first time, Americans with diabetic macular edema will have access to an FDA-approved medicine shown to help many patients rapidly regain substantial amounts of lost vision. We developed Lucentis to treat diseases of the eye and are pleased to have received this third U.S. indication to help a new population of people whose eyesight may be affected by diabetes.”