FDA Okays Lucentis for Wet Age-Related Macular Degeneration

ROCKVILLE, Md. - The FDA has approved Lucentis (ranibizumab injection) for treatment of wet age-related macular degeneration.

ROCKVILLE, July 5 ? The FDA has approved Lucentis (ranibizumab injection) for treatment of wet age-related macular degeneration.

The FDA said Lucentis, which is to be given in monthly injections that will cost ,950 per injection, is the first drug that can "maintain the vision of more than 90% of patients with neovascular (wet) age-related macular degeneration."

Genentech, which developed the drug, said it would begin shipping Lucentis immediately.

Andrew von Eschenbach, M.D., the acting FDA commissioner, said the Lucentis approval is "of great importance for the 155,000 Americans who are diagnosed each year with age-related macular degeneration, a common cause of severe and irreversible vision loss in older adults. 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."

Wet age-related macular degeneration accounts for about 10% of all age-related macular degeneration and is responsible for 80% of the vision loss associated with age-related macular degeneration.

Vision loss in patients with wet age-related macular degeneration 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.

The FDA said that Lucentis, a biologic product, administered by injection into the eye, was shown to be safe and clinically effective in three multicenter, randomized studies of patients representative of the population usually affected with age-related macular degeneration. In clinical trials, nearly 95% of the participants who received a monthly injection maintained their vision at 12 months compared with approximately 60% of patients who received the control treatment.

Approximately one-third of patients in these trials had improved vision at 12 months. In a single study carried out for 24 months, these findings have been maintained with continued monthly dosing. The most commonly reported adverse events included conjunctival hemorrhage, eye pain, floaters, increased eye pressure and inflammation of the eye. Serious adverse events were rare and often related to the injection procedure including endophthalmitis, intraocular inflammation, retinal detachment, retinal tear, increased eye pressure and traumatic cataract.

Following the approval, the Wall Street Journal reported that Avastin (bevacizumab), a cancer drug that blocks vascular endothelial growth factor, has also demonstrated efficacy for treatment of wet age-related macular degeneration. Avastin, which is approved for treatment of colorectal cancer, costs about a dose.