Genentech Gets FDA OK of Lucentis for Diabetic Eye Disease

Xconomy San Francisco — 

Genentech been losing market share to a tough new competitor in the field of macular degeneration, but now it has a new avenue for growth with its successful eye drug ranibizumab (Lucentis).

Genentech, the South San Francisco-based unit of Roche, said today it has gotten clearance to start selling the drug as a treatment for diabetic macular edema, a complication that damages the eyesight of patients with diabetes. The injectable drug, designed to block the leakage of blood vessels behind the eye, was first cleared as a treatment for the “wet” form of age-related macular degeneration in the U.S. in 2006. That’s a leading cause of blindness among elderly folks. But diabetic macular edema represents a big new pool of eligible patients. As the diabetes epidemic has grown, diabetic macular edema is now estimated to affect 560,000 people in the U.S. and is estimated to be the leading cause of blindness among adults in the U.S., Genentech said in a statement.

“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,” said Hal Barron, Genentech’s chief medical officer, in a company statement.

Although ranibizumab was considered a historic advance when it first won FDA approval in 2006 for a different group of patients, it has long been a source of controversy. It is scientifically similar to Genentech’s cancer drug bevacizumab (Avastin), so eye specialists and pharmacists have worked together to come up with low-dose versions of Avastin that serve as a lower-cost alternative—a practice which Genentech questioned for years. Now a new competitor, Tarrytown, NY-based Regeneron Pharmaceuticals (NASDAQ: REGN) has had runaway success with its own FDA-approved lower-cost alternative. But Regeneron doesn’t have FDA clearance in the diabetic macular edema population, so Genentech can claim that it has a significant new market opportunity to itself.

Genentech’s ranibizumab was tested in 759 patients with diabetic macular edema, who were followed for three years, according to an FDA statement. Between 34 percent and 45 percent of those who got a once-monthly injection of ranibizumab gained at least three lines of vision on an eye chart compared with 12 percent to 18 percent of those who did not receive an injection.

“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 FDA’s Division of Transplant and Ophthalmology Products, in a statement. “Today’s approval represents a major development for the treatment of people whose vision is impaired by diabetic macular edema as a complication of their disease.”