The U.S. Food and Drug Administration’s Dermatologic and Ophthalmic Drugs Advisory Committee voted unanimously yesterday to recommend approval of a 0.3-mg dose of Lucentis for the treatment of diabetic macular edema.
The committee also voted 8 to 2 to recommend approval of a 0.5-mg dose of the anti-VEGF agent for the new indication.
The FDA is expected to vote by Aug. 10 on the supplemental biologics license application for Lucentis (ranibizumab, Genentech) in the treatment of diabetic macular edema (DME).
Ranibizumab is already approved for the treatment of wet age-related macular degeneration and retinal vein occlusion.
In response to questions posed to the committee, members voted 10 to 0 in agreement that there is a clinically significant difference in efficacy between the two doses for DME and that substantial evidence has been provided to show the efficacy of ranibizumab for DME.
Committee members were deadlocked 4 to 4 on the question of whether there is a clinically significant difference in safety between the 0.3-mg and 0.5-mg doses in the treatment of DME.
Genentech’s supplemental biologics license application is based on results of the RIDE and RISE studies, identical sham-controlled phase 3 clinical trials in which 759 patients with DME were randomized to receive monthly sham injections or 0.3 mg or 0.5 mg ranibizumab.
Results showed rapid and sustained improvements in vision and a safety profile in DME patients similar to that of AMD patients, according to FDA investigators and Genentech representatives.
“The efficacy data of either dose are extremely similar,” Jason S. Ehrlich, MD, PhD, a consultant to Genentech, said during the meeting.
As the hearing adjourned, questions remained about the labeling of ranibizumab for DME. Committee members voted 7 to 1, with one member abstaining, to make suggestions concerning labeling.