Not a skin sensitizer in mouse local lymph node assay
“The product was not a sensitizer in the local lymph node assay performed with CBA/Ca mice at up to 50% acoltremon applied on the dorsal surface of both ears once daily (25 µL/dose) for 3 days consecutively.”
Rabbit ocular distribution: detected only in conjunctiva (2/8 eyes); other ocular tissues below LLOQ
“in an ocular distribution study in the rabbit where animals received 3 µg/eye/day (1.67-fold the therapeutic dose) for 28 days, acoltremon was detected in the conjunctiva of 2 out of 8 eyes, while cornea, conjunctiva, aqueous humor, iris/ciliary body, vitreous humor, and retina were below the LLOQ of 5.05 ng/mL in all animals.”
Local ocular tolerability; systemic exposure negligible, so no systemic on- or off-target activity expected
“this reviewer judged that the systemic exposure to the test article (free maximum plasma concentration [Cmax]) can be considered negligible and hence, neither on- nor off-target activity of the test article could be expected other than locally in the ocular tissues.”