Genentech, a wholly-owned member of the Roche Group, has reported results from two phase III studies of Lucentis (ranibizumab injection) in macular edema due to retinal vein occlusion (RVO).
The results showed, on an average, patients given either of two doses of Lucentis had an improvement in vision as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity (BCVA) at six months compared to patients receiving sham injections.
Reportedly, the data from the BRAVO study in branch-RVO showed at month six, patients who received 0.3mg of Lucentis had a mean gain from baseline BCVA 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 in patients receiving sham injections.
However, in the CRUISE study in central-RVO, at month six, patients who received 0.3mg of Lucentis had a mean gain from baseline BCVA 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 patients receiving sham injections.
In both trials, a statistically significant mean gain in BCVA was observed as early as day seven for both doses of Lucentis compared with sham. The studies were not designed to compare the two doses of Lucentis, the company said.
Hal Barron, executive vice president of global development and CMO at Genentech, said: “As early as seven days after their first injection, patients who received monthly injections of Lucentis had, on average, a statistically significant improvement in their vision that lasted through six months.”