Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced 24-month results from the two pivotal Phase III trials (RISE and RIDE) assessing the efficacy and safety of LucentisÂ® (ranibizumab injection) in people with diabetic macular edema (DME). The data showed patients who received Lucentis experienced significant, rapid and sustained improvement in vision compared to those who received placebo (sham) injections. Additional analyses showed patients who received Lucentis were significantly more likely to achieve 20/40 vision and experience less progression of the underlying diabetic retinopathy disease.
â€œThese studies showed that Lucentis helped improve vision even in patients without tight glucose control, and fewer patients who received Lucentis progressed to more advanced stages of diabetic retinopathy.â€
The safety results were consistent with previous studies and no new adverse events related to Lucentis were observed.
DME is swelling of the retina that occurs in people with diabetes, who suffer from a complication called diabetic retinopathy. Diabetic retinopathy is the most common diabetic eye disease and is characterized by damage to the blood vessels of the retina, the nerve layer at the back of the eye. DME can cause blurred vision, severe vision loss and blindness. Up to 10 percent of people with diabetes, or more than 2 million Americans, will develop DME during their lifetime.
"The data are promising for patients with diabetes because there are currently no FDA-approved medicines to treat this debilitating eye condition," said David S. Boyer, M.D. of Retina-Vitreous Associates Medical Group in Los Angeles, who presented the results today in a Late Breaking Clinical Trial session at the American Diabetes Association 71st Scientific Sessions. "These studies showed that Lucentis helped improve vision even in patients without tight glucose control, and fewer patients who received Lucentis progressed to more advanced stages of diabetic retinopathy."
It was announced previously that both the RISE and RIDE studies met their primary endpoints, demonstrating that after 24 months, a significantly greater number of patients who received Lucentis were able to read at least 15 additional letters (three lines) on the eye chart than they could at the start of the study. A preplanned subgroup analysis reported today indicated the improvements were generally similar for patients with well-controlled glucose (baseline HbA1c â‰¤ 8) and poorly controlled glucose (baseline HbA1c >8).
Additionally, in both studies, significantly more patients who received Lucentis compared with sham injections:Experienced improvements in average eye chart reading scores starting at seven days post first injection, which were sustained at 24 months; Achieved vision greater than or equal to 20/40; Were less likely to progress to more advanced (proliferative) diabetic retinopathy; and Experienced decreased retinal swelling (central foveal thickness).
Impaired vision can impact day-to-day functioning and quality of life. In both the RISE and RIDE studies, patients who received Lucentis reported greater improvements in their ability to perform vision-related daily activities such as reading and driving, compared to the sham group, based on composite responses to the National Eye Institute Visual Functioning Questionnaire-25.
Genentech plans to file a supplemental biologics license application (sBLA) with the U.S. Food & Drug Administration (FDA) for Lucentis in DME later this year.