Macugen: how long were the pivotal tox studies?

“Pivotal long term-studies in up to 9 months with intravitreous injections every 2 weeks did not cause any apparent toxic effects and there was no evidence of increased intra-ocular inflammation during the course of the studies.”

“From the total of studies performed, the 6-month rabbit and 9-month dog studies are considered pivotal.”

“The toxicology of pegaptanib was evaluated in mice, rats, rabbits, dogs and monkeys using the clinical route, IVT, and using SC and IV pegaptanib sodium administration.”