Lucentis approved for diabetic macular edema
  • Tue, 08/14/2012 - 2:30pm

Roche’s Lucentis has been approved as a treatment for diabetic macular edema in patients with diabetes.

The U.S. Food and Drug Administration approved the drug based on two clinical studies of 759 subjects. Researchers administered monthly injections of Lucentis at 0.3 milligrams or 0.5 milligrams to randomly selected participants for the first 24 months of the study. At the expiration of that 24 months, the researchers treated all patients with the monthly injections for three years.

Results revealed that 34 to 45 percent of patients who received monthly injections of Lucentis at 0.3 mg for the first 24 months regained three lines of vision or more, as opposed to the 12 to 18 percent of patients who did not receive the injection in the first 24 months. Researchers found no increased benefits with the 0.5 mg dose of Lucentis.

According to MedicineNet, diabetic macular edema occurs in diabetes patients when fluid escapes from blood vessels in the macula and causes the retina to swell. The macula aids in central vision due to its abundance of specialized nerve endings called rods and cones. Its degeneration can result in loss of sharp vision.

MedicineNet explains that diabetes occurs when the body cannot produce insulin (Type 1 diabetes), does not produce enough insulin or does not use the insulin produced to properly provide the body’s cells with the necessary sugars (Type 2 diabetes). A person can manage diabetes by treating it with insulin injections, exercise or diet depending on the type and severity of the condition.

The FDA has already approved Lucentis use in patients with neovascular age-related macular degeneration as well as macular edema following retinal vein occlusion, which the U.S. National Library of Medicine defines as “a blockage of the small veins that carry blood away from the retina.” Common side effects of Lucentis use include:

  • bleeding of the tissue that linese the inside of the eyelids and the whites of the eye;
  • eye pain;
  • deposits in the vitreous jelly of the eye, which lead people to see “floating” spots;
  • a feeling of pressure inside the eye, or intraocular pressure.

About the Contributor

Jessica Davids
I report on FDA developments and new pharmaceutical launches, risks, and safety concerns.

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