FDA approves ranibizumab injection, Lucentis

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

• patients receiving Lucentis after 24 months were able to read over two additional lines (ten letters) on the eye chart
• significant improvement in average vision were observed only a week after the first treatment
• and, after 24 months, patients were significantly more likely to maintain their vision.

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.”

For more information on the studies and the approval of Lucentis, read the full press release.

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