Roche announced that the phase-III study BRAVO showed Lucentis (ranibizumab injection) improved vision, as measured by the primary endpoint of mean change from baseline in best-corrected visual acuity at six months, in patients with macular edema due to branch retinal vein occlusion. The safety profile of Lucentis was consistent with previous experience and no new adverse events related to Lucentis were observed in the study. Retinal vein occlusion (RVO) is a common cause of vision loss that occurs when blood flow through a retinal vein becomes blocked, such as by a blood clot.
BRAVO evaluated the safety and efficacy of six monthly injections of Lucentis compared to monthly sham injections. The two doses of Lucentis studied showed a statistically significant improvement in best-corrected visual acuity (the best vision a person can achieve with an eyeglass or contact lens prescription) at six months compared to sham. Full results will be presented at the Retina Congress, September 30 to October 4, 2009, in New York.
William M Burns, head of Roche's Pharmaceuticals Division, said, "RVO is a devastating disease. We are excited that another pivotal study has demonstrated the important role Lucentis can play in improving vision in people with difficult-to-treat eye disease, and look forward to the results of Cruise, a phase-III trial in central-RVO in the third quarter of this year."
BRAVO is a multicenter, randomized, double-masked, sham injection-controlled Phase III study, designed to assess the safety and efficacy of Lucentis in treating macular edema secondary to branch-RVO.
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of neovascular (wet) age-related macular degeneration (AMD).