Genentech, Inc, a wholly-owned member of the Roche Group, announced that the phase-III study Cruise 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 central 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.

Earlier this month, Genentech announced that the phase-III study BRAVO showed Lucentis improved vision in patients with macular edema due to branch retinal vein occlusion. Full results from Cruise and Bravo will be presented at the Retina Congress, September 30 to October 4, 2009, in New York.

"We are excited that two pivotal studies have shown early and sustained improvement in vision for RVO patients treated monthly with Lucentis," said Hal Barron, executive vice president, Global Development and chief medical officer, Genentech. "These data will form the basis of the supplemental biologics license application that we will submit to the FDA for Lucentis in RVO."

Cruise evaluated the safety and efficacy profile 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.

Cruise is a multicenter, randomized, double-masked, sham injection controlled phase-III study, designed to assess the safety and efficacy of Lucentis in macular edema secondary to central-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).

Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions.