At 24 months, 33.6 percent of patients (42/125) who received 0.3 mg Lucentis and 45.7 percent of patients (58/127) who received 0.5 mg Lucentis were able to read at least 15 more letters on the eye chart than they were at baseline, compared to 12.3 percent of patients (16/130) who received sham injections. The difference between each Lucentis dose group and the sham injection group was statistically significant. The study was not designed to compare the Lucentis doses with each other.
Combined with the positive results from the phase-3 study in DME called RISE, a clone of RIDE that reported data two weeks ago (#msg-60818771), Lucentis for DME should be a shoo-in for FDA approval in this indication.
Lucentis is already approved for DME in the EU based on trials conducted by NVS (#msg-58523789).
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