Carolina Eye Associates to Offer New Macular Degeneration Drug
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 percent 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 percent of patients with wet AMD, according to the FDA.
"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 Dr. Gregory Mincey, a retina specialist with Carolina Eye Associates. "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."
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.
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 percent of those who received the monthly injection had maintained their vision after 12 months, compared to 60 percent of patients who received the placebo, according to the FDA. 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 red eye, eye pain, eye "floaters", increased eye pressure, and eye inflammation. Serious adverse events were rare.
Currently, more than 1.75 million people in the United States have AMD and 7 million more people have earlier stages of the disease.
Carolina Eye Associates urges all patients, particularly those over the age of 50, to get regular eye exams to screen for AMD and other eye disorders.
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