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FDA has approved Genetech’s Lucentis to treat retinopathy in patients with diabetic macular edema.
On Feb. 6, 2015, FDA granted Genentech expanded approval for Lucentis (ranibizumab injection, 0.3 mg) for treating diabetic retinopathy (DR) in patients with diabetic macular edema (DME). According to an agency press release, in 2008, 33% of adults 40 years or older with diabetes had some form of DR.
FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for patients who have DR with DME. The designations were based on results from successful Phase III clinical trials, according to Genentech press release. The injection, which is administered into the eye once a month, is designed to be used in conjunction with other treatments ifor blood sugar, blood pressure, and cholesterol control.
Two clinical studies were run over three years, following 759 patients, to determine the drug’s safety and efficacy. In both studies, patients who were treated with Lucentis showed significant improvement at the two-year mark, compared with those who did not receive the injection.
Lucentis was approved in 2012 for the treatment of DME, and has been an option for wet age-related macular degeneration since 2006. It has also been used to treat macular edema following retinal vein occlusion since 2010. Some of its side effects include bleeding of the conjunctiva; eye pain; floaters; and increased pressure inside the eye (intraocular pressure). Serious side effects include infection within the eyeball (endophthalmitis) and retinal detachments.