The FDA’s Dermatologic & Ophthalmic Drugs Advisory Committee voted unanimously to recommend approval of the 0.3mg dose of Lucentis (ranibizumab injection, Genentech/Roche) for treatment of diabetic macular edema (DME). The majority of the committee also recommended the 0.5mg dose.
The FDA generally follows advisory committee recommendations, although it is not required to do so.
The committee based its recommendation on data from Genentech’s Phase III trials, RIDE and RISE, which evaluated the efficacy and safety of Lucentis in patients with DME. The primary endpoint was the percentage of patients who could read an additional 15 letters (three lines) or more on the eye chart after 24 months of treatment compared to a control group.
The 0.3mg dose achieved this endpoint in 38.6% of 125 patients, and the 0.5mg dose improved it in 50% of patients. By comparison, 14.4% of patients in the placebo group achieved this improvement.
Currently, there are no drugs approved to treat DME. The conventional treatment is laser photocoagulation, which can slow or stabilize vision loss. But few patients obtain improved vision.