The FDA Approves Lucentis® For
The Treatment Of Wet Macular Degeneration
FDA Approves Drug to Maintain Vision for Macular Degeneration Patients
The Food and Drug Administration (FDA) approved Lucentis®(ranibizumab injection) for the treatment of patients with wet age-related macular degeneration (AMD) in June of 2006. Lucentis®is the first treatment which, when dosed monthly, can maintain the vision of more than 90 percent of patients with this type of AMD.
The vision loss in wet AMD is caused by the growth of abnormal leaky blood vessels that eventually damage the area of the eye responsible for central vision. Lucentis is an antibody fragment that binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A), a protein that is believed to play a critical role in the formation of new abnormal leaky blood vessels.
Lucentis®was shown to be safe and clinically effective in three multicenter, randomized studies of AMD patients. The drug is injected into the vitreous portion of the eye (the clear jelly-like substance that fills the eye from the lens back to the retina). Due to the fact that the production of VEGF-A is ongoing, routine administration of this drug is required. 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.
The most commonly reported adverse events included conjunctival hemorrhage, eye pain, floaters, increased eye pressure and inflammation of the eye. Serious adverse events such as endophthalmitis (severe inflammation of the interior of the eye), retinal detachment, retinal tear, increased eye pressure and traumatic cataract were rare and often related to the injection procedure. There is also a small increase in the risk of stroke. Clinical trial data indicated that approximately .3 percent of patients suffered a stroke when given a .3 milligram dose of Lucentis®compared to 1.2 percent of patients who received a .5 milligram dose. In addition, patients who have previously suffered a stroke may be at greater risk of having another stroke.
Please contact your physician and health insurance company for more information concerning the cost, treatment regimen, and insurance coverage for this new drug.
Adapted from the following source: The Food and Drug Administration
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