Genentech Warns of Stroke Risk with Higher Dose Lucentis

SOUTH SAN FRANCISCO, Jan. 29 -- The 0.5 mg dose of Lucentis (ranibizumab injection), the targeted therapy for neovascular age-related macular degeneration, is associated with a significantly higher risk of stroke than the 0.3 mg dose (P=0.02), according to Genentech.

An interim analysis of the ongoing SAILOR study, which compared two doses of 0.3 mg with two doses of 0.5 mg, showed a 1.2% occurrence rate of stroke in the 0.5 mg arm versus 0.3% in the lower-dose arm, Hal Barron, M.D., the chief medical officer of Genentech, said in a Jan. 24 letter to doctors.

Like Avastin (bevacuzimab), a Genentech oral medication approved for non-small cell lung cancer and colon cancer, Lucentis inhibits vascular endothelial growth factor (VEGF). Lucentis is delivered intravitereally.

The SAILOR data suggested that the stroke risk was greatest among patients with a prior history of stroke.

There was no statistically significant difference in the rate of myocardial infarction or vascular death between the two doses. Data in the safety analysis represent an average follow-up of 230 days.

SAILOR is an ongoing safety evaluation of Lucentis that was initiated in 2006 before the FDA approved Lucentis. The study is scheduled for completion and final safety analysis by the end of 2007.

The company said there are no plans to change the Lucentis label, which states that the rate of arterial thromboemblic events was less than 4% in the Lucentis clinical trials, which was not statistically different than the rate in control groups. The label states, however, that there is a theoretical risk of arterial thromboembolic events following intravitreal use of inhibitors of VEGF.

The Lucentis label states that adverse reactions include conjunctival hemorrhage, eye pain, increased intraocular pressure and interocular inflammation, and vitreous floaters.