Roche Holding AG’s Lucentis won wider U.S. approval to treat a leading cause of vision loss associated with diabetes.
The Food and Drug Administration cleared the monthly injection for diabetic macular edema, the agency said today in a statement. Lucentis is the first approved drug to treat the condition. More than 500,000 people in the U.S. have diabetic macular edema, Anthony Adamis, vice president and global head of ophthalmology at the Genentech unit of Basel, Switzerland-based Roche, said in a telephone interview.
In addition to Roche’s Lucentis, Tarrytown, New York-based Regeneron Pharmaceuticals Inc. is studying its drug, Eylea, for the condition. Lucentis and Eylea are approved to treat a similar disease called wet age-related macular edema that tends to affect people older than 60. Eylea can be used half as often and doctors also may use a cheaper cancer drug from Roche to treat the macular edema.
“Diabetes is a major public health issue in our country, and all patients with diabetes are at risk of developing diabetic macular edema,” said Renata Albrecht, director of the Division of Transplant and Ophthalmology Products in FDA’s Center for Drug Evaluation and Research. “Today’s approval represents a major development for the treatment of people whose vision is impaired by DME as a complication of their disease.”
Lucentis generated $1.7 billion last year for Roche, the world’s biggest maker of cancer drugs, according to data compiled by Bloomberg. U.S. sales of the drug declined by 5 percent in the first half of this year to 745 million Swiss francs ($802 million) compared with 2011, Roche said in its 2012 half-year report. Regeneron’s Eylea was approved in November and it can be used every eight weeks instead of monthly, as Lucentis is prescribed.
Alimera Sciences Inc., based in Alpharetta, Georgia, and Psivida Corp. also are developing a diabetic macular edema treatment known as Iluvien. The FDA has twice rejected Iluvien, most recently in November.
Studies found that 34 percent to 45 percent of those treated monthly with 0.3 milligrams of Lucentis gained at least three lines of vision on an eye chart over two years compared with 12 percent to 18 percent of patients who didn’t receive an injection, the FDA said. A 0.3 milligram-dose will cost $1,170, Terence Hurley, a spokesman for Roche’s Genentech unit, said in an e-mail.
The existing option for U.S. patients is laser therapy. Patients who received the monthly injection also were significantly more likely than those who received fake doses of the drug to achieve 20/40 vision, which is required for a driver’s license.
Lucentis and Eylea are drugs known as anti-vascular endothelial growth factors. Doctors also often use Roche’s cancer drug Avastin, also an anti-VEGF treatment, for wet age-related macular edema. Lucentis can cost 40 times as much as Avastin, making the cancer drug an attractive alternative, though its repackaging for the eye disease was linked in September 2011 to eye infections, some of which resulted in blindness.
Medicare payment advisers determined in March that anti-VEGF treatments improve health outcomes for diabetic macular edema patients and said they didn’t have enough evidence to judge among the drugs.