*Efficacy for this organism was studied in fewer than 10 infections.
The FDA approval of Besivance was based on a series of 8 clinical trials designed to test efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics. It's efficacy was evaluated in 3 multi-center, randomized, double-masked clinical trials involving nearly 2,400 patients with a clinical diagnosis of bacterial conjunctivitis. In clinical trials, investigators found that Besivance treatment resulted in a greater proportion of patients experiencing clinical resolution and microbial eradication, when compared to its vehicle.1
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In a randomized, double-masked, multicenter clinical trial, in which patients 1 to 98 years of age were dosed 3 times a day for 5 days, Besivance was superior to its vehicle in patients with bacterial conjunctivitis.
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Clinical resolution was achieved in 45 percent (90/198) of patients for the Besivance treated group versus 33 percent (63/191) of patients in the vehicle-treated group.
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The trial demonstrated a statistically significant difference in the bacterial pathogen eradication rates - 91 percent (181/198) for the Besivance treated group versus 60 percent (114/191) for the vehicle treated group.
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Microbiological eradication does not always correlate with clinical outcome in anti-infective trials.
