by Dan Roberts
February 23, 2008
The final results from Cohort 1 of the Phase IIIb SAILOR study of Lucentis in patients with wet AMD were presented on February 23, 2008 at the Bascom Palmer Eye Institute’s Angiogenesis meeting by Dr. David Boyer (Retina-Vitreous Associates Medical Group, Los Angeles). The final, one-year data support the long-term safety and efficacy profile of Lucentis.
The study, titled “Ranibizumab (Lucentis) Safety in Previously Treated and Newly Diagnosed Patients with Neovascular Age-related Macular Degeneration (AMD): The SAILOR Study,” was designed to evaluate the safety of two different doses of Lucentis (0.5 mg, the FDA-approved dose, and 0.3 mg) administered once a month for three months and thereafter as needed based on re-treatment criteria. The top line results were:
- Rates of ocular and non-ocular serious adverse events at one year were similar in patients receiving either 0.3 mg or 0.5 mg of Lucentis and consistent with previous studies, supporting the long-term safety of Lucentis
- Rates of ocular and non-ocular adverse events at one year were generally low in both dose groups and consistent with previous studies.
- One-year results also demonstrated that the FDA-approved dose of Lucentis (0.5 mg) was not associated with the higher rate of stroke observed during the planned interim analysis at six months.Ê The data suggested a trend towards a higher incidence of stroke in the 0.5 mg dose group (1.2% vs. 0.7% in the 0.3 mg group), though the results were not statistically significant (p-value=0.21).
- At one-year, patients with a prior history of stroke had a higher rate of stroke in the 0.5 group (9.6%) compared to the 0.3 group (2.7%).Ê However, this trend was inconclusive, as the number of events was small. These data are consistent with epidemiologic data showing that prior history of stroke predisposes patients to subsequent stroke.
One-year SAILOR efficacy data suggested that treating patients with Lucentis on an as needed basis may be less effective than monthly dosing.