Genentech Presents Second Phase III Study Result For Lucentis

Genentech has announced the results of its phase III study – CRUISE for Lucentis (ranibizumab injection). Data showed 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 were observed in the study, said the company.

Earlier this month, Genentech announced that the phase III study – BRAVO showed Lucentis’ effectiveness in improving vision in patients with macular edema due to branch retinal vein occlusion.

Hal Barron, executive vice president, Global Development and chief medical officer, Genentech, said: We are excited that two pivotal studies have shown early and sustained improvement in vision for RVO patients treated monthly with Lucentis. 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, as compared to monthly sham injections. The two doses of Lucentis studied showed a significant improvement in best-corrected visual acuity at six months compared to sham, said the company.