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S. Raber, R. Courtney, T. Maeda-Chubachi, B. D. Simons, S. Freedman, B. M. Wirostko; Pharmacokinetics (PK) of Latanoprost Acid in Pediatric and Adult Glaucoma Patients Treated With Latanoprost 0.005%. Invest. Ophthalmol. Vis. Sci. 2010;51(13):210.
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To inform posology and age group selection for inclusion in a latanoprost pediatric safety/efficacy study, steady-state plasma latanoprost acid concentrations were evaluated in an open-label study of pediatric glaucoma patients receiving latanoprost adult dose (1.5 µg/eye) to ensure systemic exposure was safe and well-tolerated. Adults were included as a reference group.
Patients (≥5 in each of 3 pediatric age groups and ≥15 adults) receiving latanoprost 0.005% for glaucoma or ocular hypertension for ≥2 weeks were included. Recruitment began with adults and 12 to <18 yr olds, proceeded to 3 to <12 yr, then <3 yr after satisfactory review of safety and PK for each age group. Blood samples were collected predose and 5, 15, 30, 45, and 60 min postdose for analysis of plasma latanoprost acid concentrations and estimation of PK parameters. Safety evaluation included review of clinical laboratory tests, vital signs, and adverse events.
Mean (range) age, weight and median (range) PK parameters are summarized in the table. For patients with sufficient data, median plasma elimination half-life was short (<20 min) and similar across age groups. No clinically significant adverse events or changes from baseline in vital signs or laboratory values were reported.
Systemic exposure to latanoprost acid was higher in children <12 yr compared to adults, likely a consequence of lower body weight and blood volume. A sufficient safety margin (>50-fold) for systemic adverse effects was maintained in pediatric patients based on historical data from an IV latanoprost safety study. The topical adult dose of latanoprost was safe and well tolerated in all pediatric age groups.
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