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FDA Grants Priority Review for Ranibizumab (Lucentis) in Diabetic Retinopathy

Approval decision set for February 2015

The FDA has accepted for filing a supplemental biologics license application (sBLA) and has granted a “priority review” designation for ranibizumab injection (Lucentis, Genentech) for the treatment of diabetic retinopathy, an eye disease that affects nearly 7.7 million Americans. The FDA-confirmed action date is February 6, 2015.

The sBLA was submitted in August 2014 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. If approved by the FDA, ranibizumab would be the first eye medicine available for patients with diabetic retinopathy.

Diabetic retinopathy is the most common diabetic eye disease and is the leading cause of new cases of blindness in working-age Americans. It is caused by changes in the blood vessels of the retina. In its early stages, diabetic retinopathy is often asymptomatic.

A “priority review” designation is granted by the FDA to medications that, if approved, would have the potential to provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared with standard applications.

The submission is based on results from two phase III trials (RISE and RIDE) in which meaningful improvements in diabetic retinopathy were observed in a clinically significant proportion of patients treated with ranibizumab at 2 years compared with patients treated with sham injections (control group). The benefits of ranibizumab treatment were maintained during year 3 of treatment.

Lucentis (ranibizumab) was the first FDA-approved medication for diabetic macular edema (DME), a major cause of vision loss in people with diabetic retinopathy. It was approved for this indication in August 2012, based on data from the RISE and RIDE trials.

Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis and in the hyperpermeability (leakiness) of the vessels. Lucentis (ranibizumab) is FDA-approved for the treatment of wet age-related macular degeneration (wet AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME). The medication has been studied in 21 clinical trials worldwide in more than 9,000 patients.

Source: Genentech; October 8, 2014.

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