Genentech Eye Drug, Under Scrutiny, Passes Study in Diabetic Patients to Open Up New Market

3/25/11Follow @xconomy

Genentech put out some good clinical trial news today which suggests it has a chance to expand the market of its franchise drug for eye diseases, right at the moment the drug is facing a lot of pressure.

The South San Francisco-based unit of Roche said today that its targeted drug for eye diseases met the main goal of its second pivotal clinical trial in patients with diabetic macular edema. A low dose of the drug, ranibizumab (Lucentis), was able to help 33.6 percent of patients read 15 extra letters on an eye chart after two years of use, and a higher dose helped 45.7 percent of patients see that well. By comparison, only 12.3 percent of patients on a placebo injection had that much improvement in their eyesight. Safety of Lucentis was consistent with prior studies, and detailed results will be presented at a medical meeting in May.

Genentech first won FDA approval of Lucentis in 2006, which was a watershed moment for the treatment of macular degeneration. The drug was designed to counteract the effect of leaky blood vessels behind the eye that cause visual impairment. This latest set of data could help Genentech expand the reach of Lucentis from its original use in patients with age-related macular degeneration into a distinct but related market, in which patients also have deteriorating eyesight caused by leaky blood vessels in the eye. About one out of 10 people with diabetes gets this complication. About 25 million people in the U.S. have diabetes, and incidence is soaring year by year as a direct byproduct of the obesity epidemic.

If Genentech can win FDA approval of Lucentis for diabetic macular edema, it could take some of the pressure off this drug in its original market. Instead of using Lucentis at $2,000 a dose, many eye doctors who treat macular degeneration have chosen to prescribe a tiny dose of one of Genentech’s cancer drugs, bevacizumab (Avastin), for $20 to $50 per injection, as the New York Times’ Andy Pollack described back in November. Genentech has objected for years to this practice, saying that Lucentis was specifically tested for macular degeneration, while Avastin’s clinical trials have been in cancer patients. Yet many doctors insist that Avastin is a viable alternative, and there is now an ongoing study, funded by the National Institutes of Health, which could yield evidence to prove the point.

While Lucentis already generates more than $1 billion in U.S. sales for Roche each year as it stands, and sales grew 27 percent in 2010, there’s a possibility for erosion over time if more doctors switch to Avastin as a treatment for macular degeneration.

So while today’s results will be important to doctors and to patients with diabetic macular edema, it could also mean a lot for Genentech/Roche, in terms of providing a new avenue for growth in a franchise drug facing a real threat.

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