Xdemvy (Lotilaner 0.25%)

Common Side Effects

Ocular, most common: Instillation-site stinging and burning 10% (833 patients treated for 42 days in Saturn-1 and Saturn-2).
Ocular, under 2%: Chalazion or hordeolum, punctate keratitis.
Tolerability, Saturn-2: 90.7% of patients rated the drop neutral to very comfortable, with mean compliance 98.7%.

Pregnancy & Lactation

Pregnancy: No human data; systemic exposure after ocular dosing is low and animal reproduction studies produced no malformations at clinically relevant doses. Oral dosing in rats increased post-implantation loss and reduced fetal weight with incomplete ossification only at 1390 times the recommended human ophthalmic dose on a body surface area basis and in the presence of maternal toxicity, with one fetus at that dose showing situs inversus that could not be excluded as treatment related; rabbits showed no embryofetal toxicity or teratogenic findings at 580 times the human dose on an AUC basis.

Lactation: No data on presence in human milk, effects on the breastfed infant, or milk production; systemic exposure after 6 weeks of topical dosing is low and the drug is more than 99% plasma protein bound.

Pediatric Use

Safety and effectiveness not established below age 18.