There’s more bad news out today for Genentech’s eye drug Lucentis. In the largest clinical trial to date, Avastin (bevacizumab), an inexpensive version of the same compound, worked just as well as the pricier Lucentis (ranibizumab) at preventing vision loss in people with age-related macular degeneration.
“There was no significant treatment difference between Lucentis and Avastin as measured by visual acuity outcomes,” Paul Sieving, director of the US National Eye Institute (NEI), which sponsored the trial, said at a teleconference earlier today. In a series of standard vision tests, “the two drugs were virtually identical,” added Daniel Martin, chairman of the Cole Eye Institute at the Cleveland Clinic in Ohio, and lead investigator of the 1,185-person, 43-center trial.
The comparison is a hot button issue because Avastin, a monoclonal antibody used to treat cancer, isn’t currently licensed for people with age-related macular degeneration. Yet despite its lack of approval for the blindness-associated disorder, many physicians commonly prescribe the drug off-label at just $50 per dose in place of Lucentis, which costs around $2,000 per treatment. Both drugs are marketed by South San Francisco’s Genentech.
Reporting results of the year-long trial today in the New England Journal of Medicine, Martin and his colleagues found identical vision improvements in people taking either drug, although those receiving monthly injections of medication performed somewhat better than those taking the drugs as needed. No significant differences between the two drugs were seen in the rates of death, heart attack or stroke, although more people taking Avastin were hospitalized during the trial than those on Lucentis. The trial investigators now plan to follow the study subjects for a second year of treatment as well as look at the genetics of the participants to better understand why some people need more injections than others.
Although the study results are the most definitive to date, they are not necessarily surprising. Last year, a much smaller, 22-person head-to-head study came to a very similar conclusion. And several recent Avastin–only studies have also demonstrated the efficacy of the cheaper drug for treating both macular degeneration and another vision disorder called diabetic macular edema.
Genentech, however, is not taking the results lying down. In an effort to protect its blockbuster product, the company sponsored a retrospective trial that looked at Medicare claims from around 78,000 people taking either Lucentis or Avastin. The study, led by ophthalmologist Emily Gower from the Johns Hopkins University School of Medicine in Baltimore, found an 11% higher rate of overall mortality and elevated incidences of ocular inflammation and hemorrhagic strokes in people taking Avastin.
The results will be reported next week at the Association for Research in Vision and Ophthalmology’s annual meeting next week in Fort Lauderdale, Florida. According to the Wall Street Journal, however, Genentech officials have already met with Senate staffers to highlight the health risk differences between the two medicines, and Gower also met with a Medicare official yesterday to discuss her study.