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news.Roche's subsidiary Genentech has secured approval from the US Food and Drug Administration (FDA) for Lucentis (ranibizumab injection) to treat diabetic retinopathy (DR) in people with diabetic macular edema (DME).
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Lucentis is a vascular endothelial growth factor (VEGF) inhibitor, designed to bind to and inhibit VEGF-A, a protein that is believed to play a major role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels.
It secured breakthrough therapy designation and priority review from the FDA for this indication based on results from the RISE and RIDE Phase III clinical trials.
DR with DME is a common diabetic eye disease and a leading cause of blindness in adults under 55 in the US.
Roche chief medical officer and head of Global Product Development Dr Sandra Horning said: "While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy.
"With today’s approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision."
RISE and RIDE are two identically-designed, parallel, double-masked, sham treatment-controlled trials carried out in 759 patients with DR and DME at baseline.
During these trials, patients were randomized into three groups to receive monthly treatment with 0.3mg Lucentis, 0.5mg Lucentis or sham injection.
The primary outcome in both the trials was visual acuity gain at 24 months for DME patients.