Published On: Sun, Apr 23rd, 2017

Genetech’s lucentis approved by US FDA for diabetic retinopathy treatment

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Genentech’s injection to treat , ( injection) has been approved by the U.S. Food and Drug Administration ().

The approved dosage of ranibizumab injection to be administered monthly once is 0.3mg for treating all types of diabetic retinopathy.

Diabetic Retinopathy with Lucentis Injection

Lucentis FDA approval means that the drug is now the first ever approved medicine by the American regulator for in patients who were diagnosed with or without (DME) – a condition that results from diabetic retinopathy with symptoms like inflammation in the back of the eye.

Lucentis, a a vascular endothelial growth factor (VEGF) inhibitor, had been approved by the FDA in February 2015 for diabetic retinopathy treatment in patients having diabetic macular edema following positive data recorded in two phase 3 clinical studies called as RIDE and RISE.

Diabetic Retinopathy is considered to be the major cause of blindness in working adults in the US.

lucentis (ranibizumab injection) for diabetic retinopathy treatment

lucentis (ranibizumab injection) for diabetic retinopathy treatment Photo courtesy of Genentech, Inc.

Sandra Horning, M.D., chief medical officer and head of Global Product Development at Genentech on the Lucentis FDA approval said: “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.”

The diabetic retinopathy drug, lucentis was developed by Group member, Genetech which holds its commercial rights in the US. For the rest of the world, exclusive commercial rights of the lucentis diabetic retinopathy drug are held by Novartis.

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