Aug 14, 2012 3:54 PM
Lucentis is given via a monthly injection from a health care professional.
In diabetic macular edema, fluid leaks into the macula (the middle of the retina), which is responsible for providing crisp, clear vision. The fluid swells the macula and blurs vision.
"Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema," Renata Albrecht, MD, of the FDA's Center for Drug Evaluation and Research, says in a news release.
Albrecht says the approval "represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease."
The latest approval for Lucentis was based on two clinical trials involving 759 people who were treated with the drug and followed for three years.
The results showed a significant portion of people with diabetic macular edema treated with Lucentis experienced improvement in vision, as measured by an eye chart.
For example, between 34%-45% of those treated with the recommended 0.3 milligram monthly dose of Lucentis gained at least three lines of vision compared with 12%-18% of those who did not receive the drug.
Lucentis is marketed in the U.S. by Genentech. A Genentech spokesperson estimates the monthly cost of treatment for diabetic macular edema with Lucentis at $1,170.