Data questions Avastin safety for eye use

Johns Hopkins researchers have flagged a potential safety problem with using Avastin as a treatment for macular degeneration--at least compared with use of sister drug Lucentis, which was developed specifically for the indication. The soon-to-be-published analysis of Medicare claims data--financially supported in part by Roche's Genentech, which makes both drugs--could thus help the company shore up Lucentis after years of competition from off-label use of Avastin.

According to the Wall Street Journal, the Johns Hopkins team found an 11 percent higher mortality risk and 57 percent higher risk of cerebral hemorrhage in patients using Avastin for age-related macular degeneration, compared with those using Lucentis. The data "suggest differences in the safety profile of Avastin versus Lucentis," the researchers determined. But the analysis didn't account for other factors that might affect patients' safety risks, such as smoking, high blood pressure or high cholesterol, they pointed out.

The researchers' work is due to be presented May 3. In assessing the info available, JP Morgan cautioned that the Johns Hopkins analysis might be too limited to actually support a definitive verdict on the drugs' relative safety, the WSJ notes. With Lucentis as the much-more-expensive option for macular degeneration treatment, a safety difference in its favor could mean bigger revenues for Roche and Novartis, which sells the drug in certain markets.

Meanwhile, the results of a head-to-head study by the National Eye Institute are due out soon, and that 1,200-patient trial is expected to be very influential when it comes to determining whether Avastin is a safe an effective substitute for the purpose-built Lucentis. Will that study parallel the Johns Hopkins team's conclusions? Roche must certainly hope so.

- read the WSJ story