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FDA advisory committee recommends ranibizumab injection for diabetic macular edema

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The FDA’s Dermatologic & Ophthalmic Drugs Advisory Committee has voted unanimously to recommend the approval of ranibizumab injection for the treatment of diabetic macular edema. The committee recommends approval of both the 0.3 mg and 0.5 mg doses.

The recommendation for ranibizumab injection (Lucentis, Genentech) was based on a review of data from the company’s phase 3 trials, RIDE and RISE, which evaluated the safety and efficacy of the drug in patients with diabetic macular edema. The primary endpoint was the percentage of patients who could read an additional 15 letters or more on the standard eye chart after 24 months of treatment, compared with the percentage in a control group, according to a company press release.

The FDA is expected to make a decision regarding the supplemental Biologics License Application for ranibizumab injection for this indication by August 10, 2012. The FDA generally follows advisory committee recommendations, although it is not bound to do so.