FDA Approves Lucentis for Diabetic Retinopathy

The U.S. Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME), according to the drug's manufacturer Genentech. DME impacts nearly 750,000 Americans, about 10 percent of people with DR. The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials. For a few years, physicians have used the drug "off label" to treat DR. Read more.

FDA Committee Approves Use of Lucentis for DME

Genentech says the U.S. Food & Drug Administration (FDA) Dermatologic & Ophthalmic Drugs Advisory Committee (DODAC) voted unanimously to recommend approval of the 0.3 mg dose of Lucentis (ranibizumab injection) for treatment of diabetic macular edema (DME). The majority of DODAC (8-2) also recommended the 0.5 mg dose. The FDA is expected to make a decision regarding the supplemental Biologics License Application (sBLA) for Lucentis in DME by August 10, 2012. The FDA generally follows advisory committee recommendations, although it is not bound to do so. Read more.

Lucentis-Avastin Debate Still Rages

MedicalNewsToday weighs in on the Lucentis-Avastin debate: "Genentech (Hoffman - La Roche) manufactures two critically important pharmaceuticals, Lucentis and Avastin, which are both used for treatment of several common eye diseases - including age-related macular degeneration (AMD). Despite considerable clinical similarity, the price difference between these drugs is substantial, with Lucentis generally costing up to 100 times the equivalent treatment with Avastin. A National Institutes of Health (NIH) clinical trial titled, "Comparison of AMD Treatment Trials" (CATT), is currently under way to compare the safety and efficacy of the two drugs, and the results may have far-reaching economic implications for Genentech, patients, Medicare, and third party payors."