The FDA ( Food and Drug Administration ) has approved Lucentis ( Ranibizumab injection ) for the treatment of patients with neovascular (wet) age-related macular degeneration ( AMD ).

Age-related macular degeneration, a retinal disease causing severe and irreversible vision loss, is a major cause of blindness in individuals older than 55 years.
Untreated, the majority of eyes affected with wet age-related macular degeneration may become functionally impaired.
Wet age-related macular degeneration, which accounts for 10 percent of all AMD, is responsible for 80 percent of the associated vision loss.

The vision loss in 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.

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 percent of the participants who received a monthly injection maintained their vision at 12 months compared to approximately 60 percent 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.

Source: FDA, 2006


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