FDA OKs Ranibizumab for All Forms of Diabetic Retinopathy

April 17, 2017

The US Food and Drug Administration (FDA) has expanded the indication of ranibizumab injection (Lucentis, Genentech) to include all forms of diabetic retinopathy, the drug's manufacturer announced today.

Ranibizumab is the first and only medicine approved by the FDA to treat all forms of diabetic retinopathy, with or without diabetic macular edema (DME), according to a company news release.

Ranibizumab had been approved to treat diabetic retinopathy just in patients with DME on a monthly basis. The vascular endothelial growth factor (VEFG) inhibitor is indicated also for neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, DME, and myopic choroidal neovascularization, a use approved in January.

Diabetic retinopathy is the most common ophthalmic complication of diabetes and the leading cause of new blindness in people aged 25 to 74 years in the United States.

The FDA expanded the indication for ranibizumab based on the Protocol S study of the Diabetic Retinopathy Clinical Research Network, funded by the National Eye Institute, according to the news release. The Protocol S study compared ranibizumab injections with panretinal laser treatments for patients with diabetic retinopathy, some with DME, and some without. Diabetic retinopathy became less severe for patients treated with ranibizumab whether or not they had DME. Adverse events associated with the drug resembled those in earlier studies.

Conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure are the most adverse events for ranibizumab, according to the drug's FDA-approved label. More serious adverse events include endophthalmitis and retinal detachment. Also, intravitreal injection of VEGF inhibitors such as ranibizumab carry the uncommon but potential risk for arterial thromboembolic events, some fatal.

More information on the Genentech announcement is available on the company's website.

Follow Robert Lowes on Twitter @LowesRobert

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