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June 30, 2006 -- The FDA today approved Lucentis (ranibizumab injection) to treat patients with "wet" age-related macular degenerationmacular degeneration (AMD).
The eye disease is the leading cause of severe vision loss in people 60 and older.
In AMD, the retina's central area (macula) deteriorates. In the "wet" AMD, which accounts for about 10% of AMD cases, abnormal blood vessels grow and leak underneath the macula, distorting vision.
Lucentis is the first treatment which, when taken in monthly doses, can maintain the vision of more than 90% of patients with wet AMD, according to the FDA.
FDA's Comments
"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," says Andrew von Eschenbach, MD, in an FDA news release. Eschenbach is Acting Commissioner of Food and Drugs.
"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," Eschenbach says.
Lucentis, a biologic product, is given by injection into the eye. It is designed to block new blood vessel growth and leakiness, which ultimately lead to disease progression and vision loss from wet AMD.
Lucentis is a new molecular entity, meaning it contains an active substance never before approved for marketing in any form in the U.S.
Drug's Trials
The FDA reports Lucentis was shown to be safe and clinically effective in three studies. Study participants either got monthly Lucentis shots or a medicine-free treatment (placebo).
Nearly 95% of those who received the monthly injection had maintained their vision after 12 months, compared to approximately 60% of patients who received the placebo, states the FDA.
And approximately one-third of the patients receiving Lucentis had better vision after 12 months.
In a single study carried out for 24 months, these findings were maintained with continued monthly dosing.
The most commonly reported adverse events included conjunctival hemorrhage (red eye), eye pain, eye "floaters" (free-floating chunks of the clear gel that fills the eyeball), increased eye pressure, and eye inflammation.
Serious adverse events were rare. Often related to the injection procedure, they included endophthalmitis (severe inflammation of the interior of the eye), intraocular inflammation, retinal detachment, retinal tear, increased eye pressure, and traumatic cataract.
Lucentis is made by Genentech, Inc. Genentech is a WebMD sponsor.
SOURCES: News release, FDA. WebMD Medical Reference provided in collaboration with The Cleveland Clinic: "Eye Health: Macular Degeneration." WebMD: "Ask Dr. Lloyd -- Floaters."