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Alon Harris, Cheryl L Rowe-Rendleman, Douglas T Ross, Akifumi Fujii, Takafumi Ouchi, Andrew Wood; Pressure Lowering Effect of ONO-9054: a novel FP/EP3 dual agonist. Invest. Ophthalmol. Vis. Sci. 2014;55(13):560.
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Almost 20% of patients on prostaglandin analogues (PGA) monotherapy eventually require some form of adjunctive drug therapy to sufficiently sustain low IOP. In the present study the pressure lowering effect of 4 concentrations of ONO-9054 a dual FP/EP3 agonist was examined in order to measure the proportion that sustained a target of IOP of <18 mmHg.
48 subjects with ocular hypertension (OHT) or early primary opem angle glaucoma (OAG) were washed out of all IOP lowering drugs. Those with IOP >22 mmHg at 8:00am and >21 mmHg at 10am at the eligibility visits were randomized 1:3 to placebo or one of 4 active doses of ONO-9054 at 3, 10, 20 or 30 ug/mL. Study drug was administered once a day at 7am for 14 days. The timing of IOP measures after 14 days of dosing was paired to occur at approximately the same time as the predose baseline measurements.
The percentage of patients reaching specific target pressures after 14 days dosing was determined.
In our analysis all subjects on ONO-9054 experienced a reduction in IOP to 18 mmHg or less after 14 days dosing. At higher doses of the drug, IOPs of 16 mmHg or less were more frequent.
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