Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study

• Published in: British journal of ophthalmology Vol. 101; no. 6; pp. 796 - 800
• Main Authors: Miller Ellis, Eydie, Berlin, Michael S, Ward, Caroline L, Sharpe, John A, Jamil, Alam, Harris, Alon
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.06.2017; BMJ Publishing Group
• Subjects: Adolescent; Adult; Aged; Aged, 80 and over; Clinical Science; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Glaucoma; Glaucoma, Open-Angle - drug therapy; Glaucoma, Open-Angle - physiopathology; Humans; Intraocular Pressure - drug effects; Latanoprost; Male; Middle Aged; Ocular Hypertension - drug therapy; Ocular Hypertension - physiopathology; Ophthalmic Solutions; Oxepins - administration & dosage; Prostaglandins F, Synthetic - administration & dosage; Retrospective Studies; Time Factors; Treatment Outcome; Young Adult; United States > US; Glaucoma; Clinical Trial; Intraocular pressure
• ISSN: 0007-1161; 1468-2079
• DOI: 10.1136/bjophthalmol-2016-309023

Background/aimsONO-9054 is being developed for the reduction of intraocular pressure (IOP) in patients with ocular hypertension (OHT) and open-angle glaucoma (OAG). This study compared the novel dual EP3/FP agonist ONO-9054 with the FP agonist Xalatan.MethodsAdults (n=123) with bilateral mild/moderate OAG or OHT, with unmedicated IOP of ≥24 mm Hg at 8:00 hours, ≥21 mm Hg at 10:00 hours and ≤36 mm Hg, were randomised 1:1 to receive ONO-9054 (0.003%, 30 μg/mL) or Xalatan (0.005%, 50 μg/mL) once daily for 28 days.ResultsDay 29 mean diurnal IOP was −7.2 mm Hg for ONO-9054 vs −6.6 mm Hg for Xalatan. At 08:00 hours, the IOPs were comparable, and at all later time points the decrease in IOP was greater for ONO-9054. On day 29, the odds of a mean IOP reduction of ≤−25%, ≤−30% and ≤−35% for ONO-9054 were 2.39, 2.37 and 4.85 times more, respectively, than the odds for Xalatan (p<0.05, post hoc analyses). The percentage of subjects achieving target IOPs on day 29 (≤17, ≤16 and ≤15 mm Hg) was greater for ONO-9054 than for Xalatan; the odds of achieving an IOP ≤15 mm Hg for ONO-9054 were 2.4 times more than the odds for Xalatan (p<0.01, post hoc analysis).ConclusionsSubjects randomised to receive ONO-9054 were more likely to achieve a greater per cent reduction in IOP and were more likely to achieve target IOPs than those receiving Xalatan. The effects of ONO-9054 in reducing IOP appear to persist longer than those of Xalatan.Trial registration numberNCT02083289, Results.