“The GLP monkey 39-week topical ocular toxicity study with omidenepag isopropyl did not identify a NOAEL.”
✓ VerifiedFDA pharmacology/toxicology review, p. 12Source ↗
Pivotal GLP studies
Two topical ocular monkey studies and a series of subcutaneous rat studies
“The general toxicology study package spans two species: two topical ocular monkey studies, and a series of subcutaneous-route studies in the Sprague Dawley rat.”
✓ VerifiedFDA pharmacology/toxicology review, p. 11Source ↗
Route in tox
Topical ocular (monkey); subcutaneous (rat)
“The general toxicology study package spans two species: two topical ocular monkey studies, and a series of subcutaneous-route studies in the Sprague Dawley rat.”
✓ VerifiedFDA pharmacology/toxicology review, p. 11Source ↗