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Diabetic Macular Edema Drug Wins FDA Approval

The US Food and Drug Administration (FDA) has approved Genentech's drug Lucentis (ranibizumab injection) for the treatment of diabetic macular edema (DME), an eye disease that can cause blindness in people with diabetes.

In announcing the decision to the press on Friday, the FDA said the drug is for use with "good diabetic sugar control" and is designed to be given once a month as an injection into the eye by a qualified health care professional.

Lucentis is already approved in the US for the treatment of wet (neovascular) age-related macular degeneration (AMD), and also macular edema following retinal vein occlusion (RVO).

The macula is the area in the center of the retina, which is responsible for sharp centrol vision. Damage to this part of the eye means people lose central vision (for example they can't see faces), but not peripheral vision.

DME is swelling of the macula, and begins with diabetes, which can cause damage to blood vessels in the eye. The subsequent effect on the retina is called diabetic retinopathy, the most common diabetic eye disease. The damaged blood vessels can leak blood and fluid, which causes swelling and blurred vision and can eventually lead to severe loss of vision and blindness.

The FDA reviewed two clinical studies, RIDE and RISE, that tested the safety and effectiveness of Lucentis as a treatment for DME.

Together, the studies treated and followed 759 patients for 3 years. The patients were randomly assigned to three groups: one received a 0.3 mg dose (250 patients), another received a 0.5 mg dose (252) , and the controls (257) received a sham drug for the first 24 months.

At month 24, the patients underwent an eye test where they had to read letters arranged line by line on a vision test chart.

The results showed that patients who received 0.3 mg Lucentis experienced significant vision improvements compared to controls but this was not the case with the higher dose.

Specifically, the improvements were: More patients who received the drug at 0.3 mg a dose were able to read three extra lines (15 letters) on the eye chart than controls: in the RIDE study 34% of the drug group versus 12% in the control group, and in the RISE study, this was 45% versus 18% respectively.
Patients who received the drug at the 0.3 mg dose showed an average vision improvement of more than two lines (10 letters): RIDE 10.9 versus 2.3 letters (drug group versus controls) and RISE 12.5 versus 2.6 letters respectively.
Signficant gain in average vision was seen 7 days after the first treatment.
Patients who received the 0.3 mg dose of the drug were significantly more likely to maintain their vision (defined as losing fewer than 15 letters on the eye chart): in the RIDE study, 98% of the drug group compared to 92% of controls, and in the RISE study, it was 98 versus 90% respectively.
Vision improvements measured at 24 months in the drug group were maintained with continued treatment through to 36 months. The most common reported side effects in patients treated with the drug included bleeding of the conjunctiva (the tissue that lines the inside of the eyelids and covers the surface of the white part of the eye), increased intraocular pressure (pressure inside the eye), eye pain and floaters.

David M Brown, Retinal Specialist at The Methodist Hospital, Houston Texas, and clinical trial investigator, told the press:

"This approval is an important advancement in the fight against blindness for people with diabetes."

"Now that it will be available, Lucentis therapy can begin to make a difference in the lives of our patients with DME," he added.

Figures from the US Centers for Disease Control and Prevention (CDC) show 26 million Americans have diabetes type 1 or type 2. The disease is the main cause of new blindness among 20 to 74 year olds.

According to the 2005-2008 National Health and Nutrition Examination Survey (NHANES), among Americans aged 40 and over, more than 4.2 million have diabetic retinopathy, and a subsequent analysis shows that over half a million have DME.

Renata Albrecht, director of the Division of Transplant and Ophthalmology Products in the Center for Drug Evaluation and Research at the FDA told the press:

"Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema."

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