FDA Approves Drug for Diabetic Retinopathy with Diabetic Macular Edema

The FDA approved ranibizumab injection 0.3 mg to treat diabetic retinopathy in patients with diabetic macular edema (DME).

The safety and efficacy of ranibizumab, manufactured by Genentech, Inc, to treat diabetic retinopathy with DME were established in 2 clinical studies that included 759 participants who were treated and followed for 3 years. In the studies, treatment with ranibizumab led to significant improvement in severity of diabetic retinopathy at 2 years compared with that in patients who did not receive the drug, according to the FDA.

The most common side effects of treatment with ranibizumab included bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure. Serious side effects include endophthalmitis and retinal detachment.

The FDA granted ranibizumab for diabetic retinopathy with DME breakthrough therapy designation and reviewed this new use for the drug under the agency's priority review program.

Ranibizumab was previously FDA-approved for the treatment of DME and macular edema secondary to retinal vein occlusions. Ranibizumab is also approved in the for the treatment of neovascular age-related macular degeneration. The drug is administered by intravitreal injection once monthly.

Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States.—Kerri Fitzgerald