Genentech, a member of the Roche Group, has received approval from the U.S. Food and Drug Administration (FDA) for its lucentis (ranibizumab injection), making it the first medication approved in the U.S. for the treatment of all forms of diabetic retinopathy, whether accompanied by diabetic macular edema (DME) or not.

Pioneering Treatment for Diabetic Retinopathy

The FDA’s approval marks a significant milestone in the treatment of diabetic retinopathy, a major cause of vision loss among working-aged adults in the U.S. aged 20 to 74. Lucentis, a vascular endothelial growth factor (VEGF) inhibitor, is now approved for monthly administration at a dosage of 0.3mg.

Background and Clinical Success

First approved by the FDA in February 2015 for diabetic retinopathy in patients with DME, Lucentis has shown positive outcomes in two pivotal phase 3 clinical studies, RIDE and RISE. The approval for broader application stems from Lucentis’ demonstrated efficacy in significantly improving the conditions of patients suffering from diabetic retinopathy.

Expert Commentary

Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development at Genentech, expressed her satisfaction with the FDA’s decision: “Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the U.S. between the ages of 20 and 74. We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME. In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic retinopathy.”

Global Rights and Availability

While Genentech holds the commercial rights to Lucentis in the U.S., Novartis possesses exclusive commercial rights for the drug in the rest of the world. This global partnership facilitates the widespread availability of this vital treatment option.

The FDA’s approval of Lucentis for a wider range of diabetic retinopathy patients is a crucial development in medical treatments for diabetes-related vision complications. It underscores the importance of innovative therapies in managing complex diseases and enhancing patient quality of life.

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