Drug Discovery & Development - March 10, 2011
Genentech, a member of the Roche Group, announced that two-year results from a pivotal Phase 3 trial (RISE) showed patients with diabetic macular edema (DME) who received Lucentis (ranibizumab injection) experienced rapid and sustained improvement in vision compared to those who received a placebo (sham) injection. According to the data, there was:
• A significantly greater number of people able to read at least 15 additional letters on the eye chart compared to baseline after 24 months (primary endpoint),
• Significant improvement in average eye chart reading scores at 24 months,
• Significant improvement in average eye chart reading scores demonstrated as early as seven days,
• Significantly decreased retinal swelling.
“There are no FDA-approved medicines to treat DME and these new data add to evidence showing that Lucentis can help improve vision soon after initiation of treatment,” said Dennis M. Marcus, M.D., Southeast Retina Center in Augusta, Ga., who presented the data today. “In the case of the RISE study, the significant improvements on day seven were maintained for two years.”
DME is an eye condition characterized by swelling of the retina, which can occur in patients with type 1 or type 2 diabetes and can cause blurred vision, severe vision loss and blindness. DME is a leading cause of blindness among the working-age population in most developed countries. The safety results were consistent with previous experience and no new adverse events related to Lucentis were observed in the study.
The data from RISE, the first of two pivotal Phase 3 studies of Lucentis in DME, were presented at the 34th Annual Macula Society Meeting in Boca Raton, Fla.
Date: March 10, 2011
Source: Genentech
• A significantly greater number of people able to read at least 15 additional letters on the eye chart compared to baseline after 24 months (primary endpoint),
• Significant improvement in average eye chart reading scores at 24 months,
• Significant improvement in average eye chart reading scores demonstrated as early as seven days,
• Significantly decreased retinal swelling.
“There are no FDA-approved medicines to treat DME and these new data add to evidence showing that Lucentis can help improve vision soon after initiation of treatment,” said Dennis M. Marcus, M.D., Southeast Retina Center in Augusta, Ga., who presented the data today. “In the case of the RISE study, the significant improvements on day seven were maintained for two years.”
DME is an eye condition characterized by swelling of the retina, which can occur in patients with type 1 or type 2 diabetes and can cause blurred vision, severe vision loss and blindness. DME is a leading cause of blindness among the working-age population in most developed countries. The safety results were consistent with previous experience and no new adverse events related to Lucentis were observed in the study.
The data from RISE, the first of two pivotal Phase 3 studies of Lucentis in DME, were presented at the 34th Annual Macula Society Meeting in Boca Raton, Fla.
Date: March 10, 2011
Source: Genentech
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