FDA panel backs Lucentis for DME

FDA's Dermatologic and Ophthalmic Drugs Advisory Committee voted 10-0 on Thursday that safety and efficacy data support approval of the 0.3 mg dose of Lucentis ranibizumab for diabetic macular edema. The panel voted 8-2 that data for the 0.5 mg dose of the Genentech Inc. drug also support approval. Both doses had similar efficacy against sham control in two Phase III trials, but the 0.5 mg arm had a higher rate of adverse events. The Roche (SIX:ROG; OTCQX:RHHBY) unit is only seeking approval of the lower dose for DME. The PDUFA date is in August; the specific date is not disclosed.

The panel voted 9-0, with one abstention, that no additional preapproval safety trials were necessary given doctors' experience with Lucentis in other indications. The higher dose is approved in the U.S. to treat macular edema secondary to retinal vein occlusion (RVO) and wet age-related macular degeneration (AMD). ...