* Lucentis significantly better than placebo
* Second positive Phase III results
NEW YORK, July 30 (Reuters) - Roche Holding AG’s ROG.VX eye disease drug Lucentis proved effective in helping to improve vision in patients suffering from a condition known as central retinal vein occlusion, Roche’s Genentech unit said.
This was the second six-month, late-stage study of Lucentis for retinal vein occlusion to deliver statistically significant results showing vision improvement compared with a placebo.
The drug developed by Genentech, which was acquired by the Swiss drugmaker earlier this year, is currently approved to treat wet age-related macular degeneration — the leading cause of blindness in the elderly.
Retinal vein occlusion, or 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, causing fluid to build up and vision to cloud.
The previously successful Phase III trial, also involving six-monthly injections of Lucentis, studied the drug in patients with branch RVO, where the blockage is in one or more of the four veins attached to the retina.
The latest study tested patients with central RVO, in which the blockage is in the central retinal vein that returns blood to the heart.
“We are excited that two pivotal studies have shown early and sustained improvement in vision for RVO patients treated monthly with Lucentis,” Hal Barron, Genentech’s chief medical officer, said in a statement.
Data from the two studies will be used in seeking expanded Lucentis approval for treatment of RVO, he said.
Genentech estimates that about 868,000 people suffer from branch RVO and 259,000 have central RVO in the United States, fewer than those with age-related macular degeneration.
Lucentis had sales of $875 million in 2008.
The safety profile of Lucentis is consistent with previous experience with the drug with no new adverse events seen in the study, Genentech said. (Reporting by Bill Berkrot; Editing by Ted Kerr)