Ranibizumab study yields stroke concern

February 7, 2007

South San Francisco, CA-An ongoing study of ranibizumab (Lucentis, Genentech) has found a higher incidence of stroke in patients with neovascular (wet) age-related macular degeneration who were administered a 0.5-mg dose intravitreally compared with patients who were given a 0.3-mg dose intravitreally (1.2% versus 0.3%, respectively; p = 0.02).

South San Francisco, CA-An ongoing study of ranibizumab (Lucentis, Genentech) has found a higher incidence of stroke in patients with neovascular (wet) age-related macular degeneration who were administered a 0.5-mg dose intravitreally compared with patients who were given a 0.3-mg dose intravitreally (1.2% versus 0.3%, respectively; p = 0.02).

SAILOR (Safety Assessment of Intravitreal Lucentis for AMD) trial participants with a history of prior stroke appeared to be at greater risk for a subsequent stroke, Genentech wrote in a letter to health-care providers dated Jan. 24. The result was found during a planned interim safety analysis performed on data from one cohort of patients with an average follow-up of 230 days, according to the company.

“Serious adverse events are being continuously monitored in SAILOR,” said Hal Barron, MD, Genentech’s senior vice president of development and chief medical officer. “We look forward to analyzing all of the safety data in the latter half of 2007 when the SAILOR study is completed.”

Differences between doses were not statistically significant for myocardial infarction or vascular death, he said.

“The overall safety of intravitreal injections of ranibizumab (0.3- and 0.5-mg doses) appears to be consistent with the safety experience from phase III studies as described in the [ranibizumab] injection prescribing information,” Dr. Barron added.

Health-care professionals with questions may call the Genentech Medical Information/Communication Department at 800/821-8590. Serious adverse events should be reported to the company at 888/835-2555 or to the FDA’s MedWatch reporting system at 800/332-0178 or https://www.accessdata.fda.gov/scripts/medwatch. Alternatively, the MedWatch Voluntary Reporting Form 3500 may be mailed to: Safety Information and Adverse Event Reporting Program, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787. A link to the form appears at the aforementioned Web address.

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