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Lucentis Approved to Treat Diabetic Retinopathy in Patients With Diabetic Macular Edema

FDA expands previous approvals for use of ranibizumab injection

The FDA has expanded the approved use for ranibizumab injection, 0.3 mg (Lucentis, Genentech) to treat diabetic retinopathy in patients with diabetic macular edema (DME).

Diabetic retinopathy (DR), the most common diabetic eye disease, is a leading cause of blindness in U.S. adults. According to the Centers for Disease Control and Prevention, diabetes (type-1 and type-2) affects more than 29 million U.S. residents and is the leading cause of new blindness among people ages 20 to 74 years. In 2008, 33% of adults with diabetes aged 40 years or older had some form of DR. In some cases of DR with DME, abnormal new blood vessels grow on the surface of the retina. Severe vision loss or blindness can occur if the new blood vessels break.

Lucentis is administered by a physician as an injection into the eye once a month. It is intended to be used along with appropriate interventions to control blood sugar, blood pressure, and cholesterol.

The drug’s safety and efficacy to treat DR with DME were established in two clinical studies involving 759 participants who were treated and followed for three years. In the two studies, participants being treated with Lucentis showed significant improvement in the severity of their DR at two years compared with patients who did not receive an injection.

The most common side effects include bleeding of the conjunctiva; eye pain; floaters; and increased intraocular pressure. Serious side effects include endophthalmitis and retinal detachments.

The FDA granted Lucentis for DR with DME a breakthrough therapy designation. The FDA also reviewed the new use for Lucentis under the agency’s priority review program.

The FDA previously had approved Lucentis to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula, resulting in blurred vision. Lucentis also is approved to treat neovascular age-related macular degeneration.

Source: FDA; February 6, 2015.


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