Genentech, Inc., a wholly-owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced results from two Phase III studies of Lucentis® (ranibizumab injection) in macular edema due to retinal vein occlusion (RVO), which showed, on average, patients given either of two doses of Lucentis had a clinically and statistically significant 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. Results from both trials were presented today at the Retina Congress 2009 meeting.
Data from the BRAVO study in branch-RVO showed at month six, patients who received 0.3 mg of Lucentis had a mean gain from baseline BCVA of 16.6 letters and patients who received 0.5 mg of Lucentis had a mean gain of 18.3 letters (compared to 7.3 letters in patients receiving sham injections). In the CRUISE study in central-RVO, at month six, patients who received 0.3 mg of Lucentis had a mean gain from baseline BCVA of 12.7 letters and patients who received 0.5 mg 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.
“RVO can lead to sudden loss of vision for which there are few treatment options,” said Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech. “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.”
BRAVO (FVF4165g)
BRAVO is a multicenter, randomized, double-masked, sham injection-controlled Phase III study of 397 patients designed to assess the safety and efficacy profile of Lucentis in macular edema secondary to branch-RVO. Results at six months include:
- 55.2 percent (74/134) of patients who received 0.3 mg of Lucentis and 61.1 percent (80/131) who received 0.5 mg of Lucentis had their vision improved by 15 letters or more on the study eye chart (compared to 28.8 percent (38/132) of patients receiving sham injections).
- Mean gain in BCVA was observed beginning at day seven with a 7.6 and 7.4 letter gain in the 0.3 mg and 0.5 mg study arms of Lucentis, respectively (compared with 1.9 letters in the sham injection arm).
CRUISE (FVF4166g)
CRUISE is a multicenter, randomized, double-masked, sham injection–controlled Phase III study designed to assess the safety and efficacy profile of Lucentis. The study includes 392 patients with macular edema secondary to central-RVO and at six months showed: