FDA Approves LUCENTIS for the Treatment of Wet Age-Related Macular Degeneration
June 30, 2006
The U.S. Food and Drug Administration (FDA) announced today the approval of a new drug called LUCENTIS for the treatment of wet age-related macular degeneration (AMD). AMD is a major cause of central vision loss and is a leading cause of blindness in people over 55.
"The impact of wet AMD can be devastating, affecting a person's ability to interact with family and friends, conduct daily activities and maintain overall independence," says Wolfe Eye Clinic surgeon and retina specialist Charles A. Barnes, MD. "Fortunately, research advancements have yielded treatment options like LUCENTIS to assist patients in maintaining the vision they currently possess while possibly even improving vision for some patients."
AMD occurs in two forms: dry and wet. The dry form is associated with atrophic cell death in the central retina or macula, which is required for fine vision used for activities such as reading, driving or recognizing faces. Although dry AMD accounts for 90% of cases, it is generally much less severe than wet AMD and only accounts for about 10% of severe vision loss.
The wet form of AMD is caused by growth of abnormal blood vessels under the macula. These vessels leak fluid and blood and cause scar tissue that destroys the central retina. This process results in a deterioration of sight over a period of months to years. The wet form accounts for only 10% of cases, but is responsible for 90% of severe vision loss.
LUCENTIS was specifically developed for intraocular use in the eye to treat the underlying cause of wet AMD by targeting the molecular pathway that controls the formation of new blood vessels. LUCENTIS is designed to bind and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of these new blood vessels.
In previous years, the drugs Macugen and Avastin were available to wet AMD patients. While Macugen and Avastin are similar to LUCENTIS in that they are also VEGF-A inhibitors, the effectiveness appears to continue to improve with further development.
The FDA approval of LUCENTIS is based on data from two large Phase III clinical trials (MARINA and ANCHOR). In these studies: · Nearly all patients (approximately 95 percent) treated with LUCENTIS maintained visual acuity (as defined as the loss of less than 15 letters in visual acuity) and up to 40 percent improved visual acuity (as defined as the gain of 15 letters or more in visual acuity) at one year, as measured on the Early Treatment of Diabetic Retinopathy (ETDRS) eye chart. · On average, patients treated with LUCENTIS in the MARINA study experienced an improvement from baseline of 6.6 letters at two years compared to a loss of 14.9 letters in the control group. In the ANCHOR study, patients treated with LUCENTIS, on average, experienced an 11.3 letter gain from baseline at one year compared to a loss of 9.5 letters in the photodynamic therapy control group.
"According to the National Eye Institute, there are 1.7 million people living with the advanced form of AMD in the United States alone and this prevalence will grow to 2.95 million by 2020," says Dr. Barnes. "LUCENTIS provides new hope for patients with wet AMD because it is the first therapy that may provide a benefit in vision for a number of patients, offering the possibility of a higher quality of life."