Lucentis is currently approved to treat wet age-related macular degeneration (AMD) and the Food and Drug Administration is currently considering expanding its approval of Lucentis to treat diabetic macular edema as well. Both wet AMD and diabetic macular edema involve swelling of the macula.
It's estimated that more than 500,000 Americans have diabetic macular edema and the current method of treatment is laser therapy. If Lucentis is approved as a treatment, it will be the first drug to receive approval by the FDA to treat diabetic macular edema.
Two clinical trials were conducted with 700 patients who were eligible for laser treatment. After two years of injections, almost 45 percent of the patients who took a 0.3 milligram dose of Lucentis were able to read three additional lines of letters on an eye chart. In addition, the Lucentis subjects also saw their vision improve to the point that they were able to drive. Additional studies will compare 0.3 and 0.5 milligram doses of the drug.*