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

“All studies were valid and acoltremon was negative in the Ames test, an in vitro chromosomal aberration test in human peripheral blood lymphocytes, and an in vivo micronucleus assay in the rat.”

“The committee agreed with the Division that in the absence of systemic exposure for acoltremon ophthalmic solution, 0.003%, there is no need to conduct carcinogenicity studies.”

“In embryofetal developmental studies in pregnant rats and rabbits dosed by intravenous injection daily during organogenesis from gestation days 6-17 and gestation days 7-19, respectively, no maternal or fetal toxicity was observed at 806- and 2151-fold the MRHOD of acoltremon on a mg/m 2 basis.”

“There was no evidence of test-article-related adverse effects on cardiovascular and central nervous system functions, when evaluated during the good laboratory practice (GLP) toxicity studies in the dog and the rat.”