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U.S. Department of Health and Human Services

Safety

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Lucentis (ranibizumab injection)

Audience: Ophthalmological healthcare professionals
Indication: Treatment of patients with neovascular (wet) age-related macular degeneration

[Posted 02/01/2007] Genentech informed healthcare professionals of preliminary safety information from a planned interim analysis in an ongoing study (SAILOR) which confirmed the higher incidence of stroke in the 0.5 mg dose group compared to the 0.3 mg dose group (1.2% versus 0.3%, respectively; P=0.02) of patients with neovascular (wet) age-related macular degeneration who received intravitreal Lucentis. The rates of stroke for both dose groups are lower than the rates seen in the controlled clinical trials and included in the approved labeling. The planned frequency of dosing was not the same as that described in the approved labeling. This comparison was one of many made during this interim analysis.

[January 24, 2007 – Letter – Genentech]
[June 30, 2006 - Label - Genentech]