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Cheryl L Rowe-Rendleman, Akifumi Fujii, Takafumi Ouchi, Fumitaka Suto, Douglas T Ross, Andrew Wood; Tolerability, Safety and Pharmacokinetics of ONO-9054, a novel FP/EP3 dual receptor agonist: a 14 day study in subjects with ocular hypertension or open angle glacoma. Invest. Ophthalmol. Vis. Sci. 2014;55(13):561.
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A randomized double masked clinical trial was performed to evaluate the safety, tolerability and pharmacokinetics (PK) of ONO-9054 a novel IOP lowering drug that targets both the prostaglandin FP and EP3 receptors in the eye.
48 subjects with ocular hypertension or early open-angle glaucoma were recruited to 4 cohorts and randomized 1:3 to placebo or one of 4 active doses of ONO-9054 at 3, 10, 20 or 30 μg/mL. Adverse events (AEs) and tolerability were assessed during the study period from Days 1-19, and at follow up on Day 25. Blood samples taken for PK were collected by venipuncture from predose thru 6 hours post dose.
Seventeen subjects had 23 AEs, of which 21 were regarded as mild and the remaining 2 as moderate. The most frequent systemic AE was headache (3/48). All ocular AEs were mild except for 2 moderate cases of anterior uveitis which could not be definitely related to the drug. After 14 days of dosing all patients were graded with no or mild hyperemia. The Cmax and AUClast of ONO-AG-367 increased approximately dose proportionally from 3.0 to 30 μg/mL but there were no signs of accumulation.
These data indicate that ONO-9054 is safe and well tolerated at concentrations up to 30 μg/mL. The profile of AEs is similar to that reported for currently prescribed prostaglandin analogues and the tolerability profile suggests that hyperemia may be lower. PK results indicate that neither ONO-9054 nor its active metabolite accumulate in blood and this dual agonist may become a useful tool in glaucoma medical therapy.
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