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FDA Okays Expanded Use of VEGF Drug Lucentis for Diabetic Retinopathy

Lucentis wins an indication in diabetic retinopathy.

This article is a collaboration between MedPage Today® and:

  • Medpage Today
 

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 new indication follows results of two safety and efficacy studies totaling 759 patients that showed those on ranibizumab had significant improvement in the severity of diabetic retinopathy at 2 years compared with patients who didn’t have the drug.

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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