Genentech's Lucentis Phase III trials in DME meets primary endpoints

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Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the second of two Phase III trials evaluating Lucentis® (ranibizumab injection) in patients with diabetic macular edema (DME) met its primary endpoint. The primary endpoint of the study, known as RIDE, showed that after 24 months a significantly greater number of patients who received Lucentis, compared to those who received placebo (sham) injections, were able to read at least 15 additional letters on an eye chart than they could at the start of the study. The safety results were consistent with previous Lucentis Phase III trials and no new significant safety findings were observed. Further analyses of the data are ongoing. Topline results from the RIDE study will be presented at the EURETINA Congress in London on May 29, 2011.

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, and there are currently no U.S. Food & Drug Administration (FDA) approved medications to treat DME.

"This data adds to the considerable body of clinical evidence showing that patients with DME who received Lucentis had significant improvement in vision," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Lucentis may provide physicians and patients with a potential option for DME, and we look forward to sharing the data from this study and a previous Phase III trial with the FDA and medical community."

In February, Genentech announced that the RISE study, the first of the two Phase III studies evaluating Lucentis in patients with DME, had met the same primary endpoint. Topline results from RISE were presented March 10 at the Macula Society Meeting and showed that patients with DME who received Lucentis experienced rapid and sustained improvement in vision beginning at day seven, which was sustained at 24 months. RIDE and RISE are identical Phase III studies designed to support a marketing application to the FDA for a potential new indication for Lucentis in DME.

RIDE Study Results

At 24 months, 33.6 percent of patients (42/125) who received 0.3 mg Lucentis and 45.7 percent of patients (58/127) who received 0.5 mg Lucentis were able to read at least 15 more letters on the eye chart than they were at baseline, compared to 12.3 percent of patients (16/130) who received sham injections. The difference between each Lucentis dose group and the sham injection group was statistically significant. The study was not designed to compare the Lucentis doses with each other.

In the study, changes in vision were measured by best-corrected visual acuity (BCVA), which is the best possible vision a person can achieve with corrective lenses, based on reading a standardized eye chart.

Key secondary endpoints met statistical significance and included average eye chart reading scores over time and changes in retinal swelling.

Safety

A preliminary analysis of the 24-month data from the RIDE study showed an ocular and systemic safety profile consistent with previous Lucentis Phase III trials.

Common ocular adverse events that occurred more frequently in the Lucentis dosing groups than in the sham injection group included conjunctival hemorrhage, eye pain, eye irritation, vitreous floaters, retinal exudates and increased intraocular pressure.

Patients receiving Lucentis in the RIDE study experienced fewer adverse events associated with diabetic retinopathy compared with the sham injection group including vitreous hemorrhage, retinal neovascularization and iris neovascularization.

Among non-ocular or systemic serious adverse events in the RIDE study, 1.6 percent of patients in the sham injection group, 1.6 percent of patients in the 0.3 mg Lucentis dose group and 2.4 percent of patients in the 0.5 mg Lucentis dose group had a stroke (cerebrovascular accident). A total of 4.7 percent of patients in the sham injection group, 5.6 percent of patients in the 0.3 mg Lucentis dose group and 2.4 percent of patients in the 0.5 mg Lucentis dose group experienced a heart attack (myocardial infarction). Two patients in the sham injection group, four patients in the 0.3 mg Lucentis dose group and six patients in the 0.5 mg Lucentis dose group died during the study. Three of the six deaths in the 0.5 mg Lucentis dose group were from non-vascular causes.

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