FDA MedWatch - Lucentis (ranibizumab injection) - Preliminary Safety Information From a Planned Interim Analysis In an On-Going Study (SAILOR Study)
ROCKVILLE, Md., Feb. 1, 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 o.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.
Read the complete MedWatch 2007 Safety summary, including links to the Sponsor's Dear Healthcare Provider Letter regarding this issue and prescribing information for Lucentis attached.
Posted: February 2007