Vizz: genotox, carcinogenicity and repro: done or skipped?

“Aceclidine did not show any potential to cause genetic toxicity in a series of studies that included: 1) bacterial assays (Salmonella and E. coli) for reverse gene mutations; 2) an in vitro chromosome aberration assay in cultured human peripheral blood lymphocytes; and 3) an in vivo chromosome aberration assay (micronucleus test) in mice.”

“Long term studies in animals have not been performed to evaluate carcinogenic potential.”

“In embryofetal development studies, oral administration of aceclidine to pregnant rats and rabbits throughout organogenesis produced no maternal toxicity, skeletal anomalies, nor reduction in fetal body weight at 1.5 mg/kg/day”

“QT prolongation Not studied. Given that systemic exposure to aceclidine in the proposed dosage is very limited, the risk of QT prolongation with ocular administration would be low.”