Roche Holding AG’s Lucentis, a treatment for age-related vision loss, was effective in treating eye complications caused by diabetes, two company studies found.
The studies, which together enrolled 759 patients with diabetic macular edema, found that Lucentis improved vision and reduced abnormal growth of blood vessels in the eye, according to the research presented today at the American Diabetes Association meeting in San Diego. Data also showed that Lucentis patients were more likely to achieve 20/40 vision -- enough eyesight to drive -- than those given a placebo treatment.
Macular edema, or swelling of the retina, is common in diabetes and the leading cause of blindness in working age U.S. adults, said Anthony Adamis, the global head of ophthalmology at Basel, Switzerland-based Roche’s Genentech unit. Lucentis was approved in 2006 for age-related macular degeneration. Roche plans to submit these studies with U.S. regulators “in the fall” to seek approval for the indication, Adamis said.
“We’re excited about these data,” Adamis said in an interview. “This is a difficult disease.”
Almost 30 percent of diabetics older than age 40 had vision damage from 2005 to 2008, according to the American Diabetes Association. Current therapy, developed in 1985, involves the use of lasers to slow the rate of loss, Adamis said.
Macular edema occurs when extra fluid leaks from blood vessels in the eye, causing swelling and damage to the retina. Lucentis is designed to block a protein called VEGF, which encourages blood vessels to leak the fluid. Inhibiting VEGF stops the leaks, Adamis said.
Roche’s cancer drug Avastin, which costs less than Lucentis, also targets VEGF and doctors sometimes use it off-label to treat patients with age-related macular degeneration. Avastin costs $50 per shot, while Lucentis costs about $2,000 for each injection. Avastin may raise risks of death and stroke compared with Lucentis, according to an analysis of Medicare data released in May.
In the 377-patient study dubbed RISE, about 45 percent of patients taking a 0.3 milligram dose of Lucentis and 39 percent of those on 0.5 milligrams were able to read an additional 15 letters on an eye chart after treatment, compared with about 18 percent of those getting a sham treatment. About 63 percent of those on the higher Lucentis dose recovered enough vision to be able to legally drive, compared with 38 percent of those getting a placebo in the RISE trial.
Two Sets of Results
In a 382-patient trial, dubbed RIDE, patients were grouped into the same three groups as before. In this trial, 34 percent on a low dose of Lucentis and 46 percent of those on a higher dose recovered 15 or more letters on the eye chart, compared with 12 percent of patients getting a sham treatment. About 54 percent on the low dose of Lucentis and 62 percent on the high dose, had enough eyesight restored to be able to drive, compared with about 35 percent receiving a placebo.
In the RIDE study, 11.5 percent of patients who didn’t get the eye drug went on to worsened disease, compared with 3.2 percent of patients who were on the low dose of Lucentis and 3.9 percent on the high dose.
Most of the patients started with vision of about 20/80, meaning their vision at 20 feet was the same as the average person’s vision at 80 feet, said David Boyer, a doctor at the Retina-Vitreous Associates Medical Group in Los Angeles, who presented the results today.
“We now have a treatment that causes a rapid, significant sustained improvement,” Boyer said. “Getting 60 percent of patients to 20/40 vision, allowing them to drive without restrictions is significant.”
Lucentis was developed by Roche’s Genentech unit and Basel, Switzerland-based Novartis AG. Roche markets Lucentis in the U.S., while Novartis sells the drug in the rest of the world. Lucentis generated $1.4 billion in sales last year, according to Bloomberg data.
-- Editors: Angela Zimm, Andrew Pollack