Beovu: which tox species, and why?

“Cynomolgus monkeys were chosen as they are the only species in which brolucizumab is both pharmacologically active and possessing a similar ocular anatomy to humans.”

“Cynomolgus monkeys were chosen as they are the only species in which brolucizumab is both pharmacologically active and possessing a similar ocular anatomy to humans.”

“The non-clinical safety of up to 6 mg brolucizumab was established for intravitreal IVT in cynomolgus monkeys and rabbits”

“3 GLP repeat-dose studies (Study N-10-104, Study N-12-042 and Study N-14-007) were conducted with the GMP material to determine the potential ocular toxicity, tolerability, and systemic exposure of brolucizumab in Cynomolgus monkeys after repeated IVT injections.”

“In an animal reproduction study, intravitreal administration of brolucizumab to pregnant monkeys once every 4 weeks in one eye from organogenesis to birth did not indicate any harmful effects with respect to pre- or postnatal development at 10-fold the maximum recommended human dose (MRHD) on a mg/kg basis”

“No studies have been conducted on the carcinogenic or mutagenic potential of BEOVU.”

“These results showing a cross-reactivity towards mouse and rat VEGF allow assessment of ESBA 1008 efficacy in rat and mouse animal models such as the laser-induced CNV (choroidal neovascularization) during in vivo pharmacology studies.”