Results announced from a late stage (phase 3) clinical trial showed that the angiogenesis inhibitor Lucentis® (ranibizumab injection) improves vision in people with diabetic macular edema (DME), a leading cause of vision loss in people with diabetes. DME is a serious complication of diabetes that affects up to 10% of people with the disease.

In DME, damaged blood vessels leak fluid into the central portion of the retina, called the macula, causing it to swell. The macula is the part of the eye responsible for sharp central vision. DME can lead to blurred vision, severe vision loss, and even blindness. Lucentis treats DME by inhibiting the growth of abnormal blood vessels (angiogenesis) in the eye.

In the study, known as RISE, a significantly higher percentage of patients receiving monthly Lucentis injections achieved an improvement in best-corrected visual acuity (BCVA) at 24 months compared to those who received placebo (sham) injections. BCVA is the best possible vision a person can achieve with corrective lenses, as measured by reading an eye chart. In the study, patients who got Lucentis had an improvement of at least 15 letters on an eye chart compared with those who got placebo.

RISE was designed to assess the safety and efficacy profile of Lucentis in 377 patients with DME. The primary endpoint compared the proportion of Lucentis and placebo-treated patients who gained at least 15 letters in BCVA at 24 months. Patients were randomized to receive monthly injections of either 0.3 mg Lucentis, 0.5 mg Lucentis, or monthly sham injections. The study was not designed to compare the two doses of Lucentis, but each dose against the control group. After month 24, patients in the control group were eligible to receive monthly injections of 0.5 mg Lucentis, and all patients will continue to be followed for 36 months.

Approximately 26 million people in the U.S. have diabetes and 1.9 million new cases are diagnosed in people aged 20 and older each year. Between 40% and 45% of Americans diagnosed with diabetes have some stage of diabetic retinopathy. Up to 10% of all people with diabetes will develop DME during their lifetime, and up to 75,000 new cases of DME are estimated to develop each year. The current standard of care for DME is laser surgery that helps seal the leaky blood vessels to slow the leakage of fluid and reduce the amount of fluid in the retina. Patients may need multiple laser treatments to control the leaking fluid caused by DME.

Lucentis has already proven effecting in treating wet age-related macular degeneration (AMD), a leading cause of vision loss in the elderly. In wet AMD, blood vessels grow under the retina and leak blood and fluid causing rapid damage to the macula, the portion of the eye responsible for fine, detailed central vision. Lucentis was approved by the FDA for the treatment of wet AMD in June 2006. Lucentis was also approved for macular edema following retinal vein occlusion (RVO) on June 22, 2010.

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