Roche Holding AG’s Lucentis works to treat a leading cause of blindness associated with diabetes, U.S. regulators said.
The injection improved vision in people with diabetic macular edema, Food and Drug Administration staff said in a report today ahead of a July 26 meeting of agency advisers on expanding approval of Lucentis. The drug is already used to treat wet age-related macular degeneration. Both diseases involve swelling of the macula, in the center of the retina.
Lucentis, if approved, would be the first drug cleared for diabetic macular edema. More than 500,000 people in the U.S. have the disease, Anthony Adamis, vice president and global head of ophthalmology at Roche’s Genentech unit said in a telephone interview. Patients now receive laser therapy. Regeneron Pharmaceuticals Inc., based in Tarrytown, New York, is studying its Eylea to treat the condition.
“I think this is going to be transformative for those people,” Adamis said. “Laser essentially slows the rate of vision loss but very few people gain vision. But what we saw in our trial is people gained vision and significant vision.”
Roche, based in Basel, Switzerland, studied Lucentis as a monthly injection in a study of 700 patients, about two-thirds who used the medication while the rest received fake injections, Adamis said. All were eligible for laser treatment. Almost 45 percent and 34 percent of patients who took a 0.3 milligram dose of Lucentis were able to read three additional lines of letters on an eye chart after two years of injections during two clinical trials, according to Genentech.
Lucentis patients also were significantly more likely to achieve 20/40 vision, enough eyesight to drive.
Advisers will compare 0.3 and 0.5 milligram doses of the drug.
Lucentis brought in $1.7 billion for Roche last year, according to data compiled by Bloomberg.
Lucentis and Eylea are drugs known as anti-vascular endothelial growth factors. Roche’s cancer drug Avastin also is an anti-VEGF treatment doctors commonly use to treat wet age-related macular degeneration even though it doesn’t have FDA approval for the disease. While drugmakers can’t promote medicines for uses they aren’t approved for, physicians can prescribe them for indications not on the label.
Lucentis costs 40 times as much as Avastin. Sixty percent of Medicare beneficiaries with macular degeneration received Avastin in 2008, Philip Rosenfeld, an ophthalmology professor at the University of Miami’s Miller School of Medicine, told a Senate committee a year ago. The repackaging of Avastin 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 and said they didn’t have enough evidence to judge between the drugs.