Lucentis is already approved in the US for the treatment of wet (neovascular) age-related macular degeneration (AMD), and also macular edema following retinal vein occlusion (RVO).
The macula is the area in the center of the retina, which is responsible for sharp central vision. Damage to this part of the eye means people lose central vision (for example they can’t see faces), but not peripheral vision. Diabetic Macular Edema is swelling of the macula, and begins with diabetes, which can cause damage to blood vessels in the eye. The subsequent effect on the retina is called diabetic retinopathy, the most common diabetic eye disease. The damaged blood vessels can leak blood and fluid, which causes swelling and blurred vision and can eventually lead to severe loss of vision and blindness.
The FDA reviewed two clinical studies, RIDE and RISE, that tested the safety and effectiveness of Lucentis as a treatment for DME. Together, the studies treated and followed 759 patients for 3 years. The patients were randomly assigned to three groups: one received a 0.3 mg dose (250 patients), another received a 0.5 mg dose (252) , and the controls (257) received a sham drug for the first 24 months. At month 24, the patients underwent an eye test where they had to read letters arranged line by line on a vision test chart. The results showed that patients who received 0.3 mg Lucentis experienced significant vision improvements compared to controls but this was not the case with the higher dose.
According to the 2005-2008 National Health and Nutrition Examination Survey (NHANES), among Americans aged 40 and over, more than 4.2 million have diabetic retinopathy, and a subsequent analysis shows that over half a million have Diabetic Macular Edema. Dr Ashraf of the Atlanta Vision Institute points out that both in the United States and worldwide the incidence and prevalence of diabetes is increasing. There is potential for an increase in the incidence of blindness due to diabetes. With this significant advance in the treatment of diabetic macular edema many people may be able to save their eyesight.
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