Genentech, Inc., a member of the Roche Group, announced that its second Phase III study known as RISE, which is evaluating the drug Lucentis in patients with diabetic macular edema, met its primary clinical endpoint. Results showed that after 24 months, a significantly higher percentage of patients receiving monthly injections of Lucentis experienced improved vision on a standard eye exam, compared to those receiving placebo injections.
People with diabetes frequently develop macular edema, a condition in which fluid accumulates within the macula—the central portion of the retina that is flush with specialized nerve endings that detect color and fine detail. The fluid build up causes the macula to swell which can lead to blurring in the middle of the visual field, making activities such as reading and driving difficult. If the swelling is not treated, it can lead to severe visual impairment and even blindness.
Lucentis, or ranibizumab injection, stabilizes or reverses these macular edema symptoms by blocking the effects of a protein known as vascular endothelial growth factor, or VEGF. The protein, which appears to be connected to several eye diseases, including age-related macular degeneration, encourages the growth of cells on the inner walls of blood vessels. The overgrowth of cells suffocates nerve endings in the macula, leading them to wither.
In 2011, Lucentis was approved for the treatment of diabetic macular edema in Europe, but the drug has not yet been approved by the Food and Drug Administration to specifically treat this condition in the United States. However, the drug is approved by the FDA for the treatment of age-related macular degeneration and macular edema following retinal vein occlusion, two conditions that are not specific to diabetes.