Genentech announced 24-month results from the two Phase III trials (RISE and RIDE) assessing the efficacy and safety of Lucentis (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 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.
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.
“The data are promising for patients with diabetes because there are currently no FDA-approved medicines to treat this debilitating eye condition,” says David S. Boyer, MD of Retina-Vitreous Associates Medical Group. “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 indicated the improvements were generally similar for patients with well-controlled glucose.
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.
Release Date: June 28, 2011
Filed Under: Drug Discovery