Jul 3 2006
A new drug with the capacity to reverse vision loss in some patients with age-related macular degeneration (AMD) has won approval from the Food and Drug Administration (FDA) in the U.S.
Age related Macular Degeneration is a progressive eye condition affecting as many as 15 million Americans and millions more around the world.
The disease attacks the macula of the eye, where the sharpest central vision occurs and even though it does not as a rule result in total blindness, sufferers are left with only the outermost, peripheral vision, leaving only dim images or black holes at the center of vision.
There are several types of macular degeneration, but the fastest growing form is age-related macular degeneration which is the number one cause of vision loss and legal blindness in adults over 60 in the U.S.
It has been found that the drug Lucentis when injected into the eye once a month maintained vision in 95 percent of patients with the wet form of age-related macular degeneration who were treated for 12 months, and in one-third of the patients their vision improved.
Those who regained some of their vision were able to read at least three more lines on an eye chart after a year.
Up to 40 percent of patients treated with Lucentis achieved vision of 20/40 or better.
According to the FDA's division of anti-infective and ophthalmologic products, the 95% retention rate is higher than any other product to date; as a rule a 60% rate is the most seen to date.
Wet AMD is the most serious form and occurs when blood vessels form behind the eye and begin to leak and block vision.
Both Lucentis and another drug Macugen are injected into the eye to cut off nutrients needed by those vessels to grow.
The FDA says in trials the most common side effects seen with Lucentis were eye pain, inflammation and pressure.
Serious problems were rare and usually related to the injection procedure.
They included severe inflammation of the eye's interior and retinal detachment or tears.
Experts say the drug provides new hope for patients with wet AMD because of its potential to reverse vision loss.
The impact of wet AMD they say extends way beyond vision loss and can affect a person's ability to interact with family and friends, conduct daily activities and, overall, maintain their independence.
Lucentis is known generically as ranibizumab, and is produced by Genentech.