TABLE 2.

Safety Outcomes of Lotilaner Ophthalmic Solution 0.25% Pivotal Trials

SATURN-1

SATURN-2

Rate of 1 or more ocular treatment-emergent AEs with treatment vs control: (19.8% [42/212] vs 21.5% [45/209]) Ocular AEs (ie, incidence >1.0% in either treatment or control group) Instillation site pain (11.8% vs 7.7%) Instillation site pruritis (1.4% vs 3.3%) Reduced visual acuity (2.8% vs 2.9%) Eye pain (1.4% vs 1.4%) Eye discharge (1.4% vs 1.0%) Chalazion (0.5% vs 1.4%) All ocular AEs in the study group were mild

Rate of 1 or more study drug–related ocular treatment-emergent AEs with treatment vs control: (19.2% [39/203] vs 12.4% [26/209]) Ocular study drug–related AEs (ie, incidence ≥1.0% in either treatment or control group) Instillation site pain (7.9% vs 6.7%) Dry eye (1.5% vs 0.5%) Visual acuity reduced (0.5% vs 1.4%) Chalazion (1.0% vs 0.0%) Conjunctival hyperemia (1.0% vs 0.0%) Eyelid pruritus (1.0% vs 0.0%) Photophobia (1.0% vs 0.0%), visual impairment (0.0% vs 1.0%) Instillation site irritation (1.0% vs 0.0%) Vital dye staining of the cornea present (1.0% vs 0.0%) Most ocular AEs were mild

Adapted from Yeu et al³ and Gaddie et al.⁴

AE = adverse event.