FDA approves Genentech’s Lucentis for diabetic macular edema

Hannah Blake

pharmaphorum

Genentech’s Lucentis has been approved by the FDA to treat patients with diabetic macular edema (DME), making it the first and only FDA-approved medicine for this condition.

DME is a sight-threatening eye disease that occurs in people with diabetes. Genentech has developed Lucentis (ranibizumab injection), which is an injection to be administered once a month by a healthcare professional, and it is intended to be used along with good diabetic blood sugar control.

“For the first time, Americans with diabetic macular edema will have access to an FDA-approved medicine shown to help many patients rapidly regain substantial amounts of lost vision. We developed Lucentis to treat diseases of the eye and are pleased to have received this third U.S. indication to help a new population of people whose eyesight may be affected by diabetes.”

Hal Barron, M.D., chief medical officer and head, Global Product Development.

Over 750 patients were involved in two clinical studies to establish the drug’s safety and effectiveness to treat DME, and were treated and followed for three years. The patients were randomly assigned to receive monthly injections of Lucentis at 0.3mg, 0.5mg or no injections during the first 24 months of the studies. Results showed that between 34 and 45% of those treated with monthly Lucentis o.3mg gained at least three lines (on an eye chart) of vision, compared to 12 to 18% of those who did not receive an injection. No additional benefit with the higher monthly Lucentis dose was found.

“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema. Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”

Renata Albrecht, M.D., director of the Division of Transplant and Ophthalmology Products in FDA’s Center for Drug Evaluation and Research, on Friday 10th August, 2012.

Type 1 and type 2 diabetes affects approximately 26 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years, according to the Centers for Disease Control and Prevention.