FDA Approves Drug for Diabetes-Related Vision Loss

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On August 10, pharmaceutical manufacturer Genentech announced the approval of its eye drug Lucentis (ranibizumab injection) by the US Food and Drug Administration for treatment of diabetic macular edema.

In diabetic macular edema, or DME, fluid leaks into an area in the middle of the retina known as the macula, which is responsible for providing crisp vision and fine detail. The macula swells and vision blurs.

Lucentis, which is also approved to treat wet age-related macular degeneration and macular edema following retinal vein occlusion, is administered via a monthly injection into the eye by a health-care professional.

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The safety and effectiveness of Lucentis for treating DME was established through two clinical trials involving 759 people who were treated and followed for three years. The data showed that 34% to 45% of participants who received a monthly injection of 0.3 milligrams of Lucentis gained three lines of vision on an eye chart, compared to 12% to 18% of those who did not receive Lucentis injections.

According to Renata Albrecht, MD, from the FDA’s Center for Drug Evaluation and Research, “All patients with diabetes are at risk of developing diabetic macular edema,” and the approval of Lucentis “represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”

Lucentis should not be taken by people who have an infection in or around the eye or who are allergic to any of the medicine’s ingredients. The most common side effects of Lucentis include redness in the whites of the eyes, eye pain, floaters (small spots in vision), the feeling of something being in the eye, headache, nose and throat infection, and respiratory infection. Rare but serious side effects include detached retina, cataracts, and serious eye infection.

Genentech spokesperson Terence Hurley has estimated the cost of treatment with Lucentis to be roughly $1,170 per month. The manufacturer offers programs to subsidize or eliminate the cost of the drug for people without insurance and those with insurance who meet certain criteria. For more information, visit the Web site for Genentech Access Solutions or call (866) 4ACCESS (422-2377).

To learn more about Lucentis, read the article “New Drug for Diabetes-Related Vision Loss approved,” or see the official press release or the Lucentis Web site.

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