Not a skin sensitizer in the mouse local lymph node assay
“In a Local Lymph Node Assay in the mouse, ACH 2224920 did not have the potential to cause skin sensitization.”
✓ VerifiedFDA pharmacology/toxicology review, p. 67Source ↗
Biodistribution & persistence
Accumulates in eyelid margins, with lowest clearance and AUC 10-fold higher than other ocular tissues
“Overall, the data indicated that inferior and superior eyelid margins were prone to drug accumulation, coupled with the lowest clearance in these tissues and an AUC inf 10-fold higher than in all other ocular tissues.”
✓ VerifiedFDA pharmacology/toxicology review, p. 7Source ↗
Modality-specific risk
Local ocular/nasal toxicity: nasal turbinate and nasopharynx not examined histologically in ocular studies
“Nasal turbinate and nasopharynx were not examined under the microscope in any of the ocular studies which was a drawback to the complete evaluation of the potential ocular toxicity of Lotilaner Ophthalmic Solution, 0.25%, but does not influence the decision on approvability of this product.”
✓ VerifiedFDA pharmacology/toxicology review, p. 12Source ↗