Lucentis wins an indication in diabetic retinopathy.
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The FDA has expanded the use of ranibizumab (Lucentis) 0.3 mg for diabetic retinopathy in patients with diabetic macular edema (DME).
The monthly injection is intended for use with ”appropriate interventions to control blood sugar, blood pressure, and cholesterol,” the agency said.
The most common side effects were bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure, and serious side effects included endophthalmitis and retinal detachments, the FDA said.
Ranibizumab was previously approved to treat DME, along with another vascular endothelial growth factor (VEGF) inhibitor, aflibercept (Eylea).
Both drugs are also approved for wet age-related macular degeneration and macular edema secondary to retinal vein occlusion.
Controversy has swirled around VEGF inhibitors for eye diseases because clinicians had been using cheaper bevacizumab (Avastin) off-label instead of the costlier agents.
From http://www.medpagetoday.com
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