The FDA says Lucentis is a new molecular entity, meaning it contains an active substance that has never before been approved for marketing in any form in the U.S. Lucentis will be the first FDA-approved product to provide prescription information in the new format for prescription drug package inserts. These are designed to provide professionals and consumers clear and concise prescription information.
Dr. Andrew von Eschenbach, Acting Commissioner of Food and Drugs, says in a statement, "This approval is of great importance for the 155,000 Americans who are diagnosed each year with AMD, a common cause of severe and irreversible vision loss in older adults." He adds, "At a time when our elderly population is rapidly increasing, this product preserves quality of life for those affected by this disease, helping them to regain the ability to participate in everyday activities such as reading and driving."
AMD is a retinal disease that causes severe and irreversible vision loss. It is a major cause of blindness in individuals older than 55 years. If left untreated, the majority of eyes affected with wet AMD may become functionally impaired.
Wet AMD accounts for 10 percent of all AMD,and is responsible for 80 percent of the associated vision loss. The vision loss in wet AMD is caused by the growth of abnormal leaky blood vessels that eventually damage the area of the eye responsible for central vision. Lucentis is designed to block new blood vessel growth and leakiness, which ultimately lead to disease progression and such vision loss.
