Genentech has announced positive results from two Phase III studies of Lucentis, which showed significant improvement in vision for patients suffering from macular edema due to retinal vein occlusion (RVO).
During the trials, called Bravo and Cruise, patients given either of two doses of Lucentis showed a statistically significant improvement in vision as at six months compared patients given a placebo.
RVO occurs when blood flow through a retinal vein becomes blocked, causing swelling (macular edema) and hemorrhages in the retina, which may result in vision loss.
Genentech MD, executive vice president, global development and chief medical officer Hal Barron said that RVO can lead to sudden loss of vision, for which there are few treatment options.
“On average, patients who received monthly injections of Lucentis showed a statistically significant improvement in their vision as early as seven days lasting through six months,” Barron said.
During the Bravo study, patients who received 0.3mg of Lucentis had a mean gain of 16.6 letters and patients who received 0.5mg of Lucentis had a mean gain of 18.3 letters, compared to 7.3 letters for patients receiving sham injections.
In the CRUISE study in central-RVO, at month six, patients who received 0.3mg of Lucentis had a mean gain of 12.7 letters and patients who received 0.5mg of Lucentis had a mean gain of 14.9 letters, compared to 0.8 letters for sham injections.