Vitravene: how long were the pivotal tox studies?

“No intact fomivirsen was observed in any of tissues (kidney, liver, ovary, and uterus) following 1, 3, or 8 doses of 10 uM (115 ug) fomivirsen administered every-other-week for three months.”

“To evaluate the effects of ISIS 2922 on ocular tissues in cynomolgus monkeys that have received prophylactic corticosteroid treatment and to determine the systemic exposure (i.e. plasma, kidney, liver, and uterus concentrations) following multiple intravitreal injection.”

“Ocular kinetic parameters of fomivirsen following intravitreal injection to rabbits and monkeys are summarized in the following table.”