title: Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: results of a 28-day, double-masked, randomised study.
abstract: ONO-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.
  
  
  
  Adults (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.
  
  
  
  Day 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 hocanalyses). 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 hocanalysis).
  
  
  
  Subjects 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.
  
  
  
  NCT02083289, Results.
authors.affiliation: Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Eydie
authors.initials: E
authors.lastname: Miller Ellis
authors.affiliation: Glaucoma Institute of Beverly Hills & Jules Stein Eye Institute, UCLA, Los Angeles, California, USA.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Berlin
authors.affiliation: Ono Pharma UK, London, UK.
authors.forename: Caroline L
authors.initials: CL
authors.lastname: Ward
authors.affiliation: Ono Pharma UK, London, UK.
authors.forename: John A
authors.initials: JA
authors.lastname: Sharpe
authors.affiliation: Ono Pharma UK, London, UK.
authors.forename: Alam
authors.initials: A
authors.lastname: Jamil
authors.affiliation: Eugene and Marilyn Glick Eye Institute, Indiana University School of Medicine, Indianapolis, Indiana, USA.
authors.forename: Alon
authors.initials: A
authors.lastname: Harris
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005902:Glaucoma, Open-Angle / Q000188:drug therapy* / Q000503:physiopathology; D006801:Humans; D007429:Intraocular Pressure / Q000187:drug effects*; D000077338:Latanoprost; D008297:Male; D008875:Middle Aged; D009798:Ocular Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D009883:Ophthalmic Solutions; D010082:Oxepins / Q000008:administration & dosage*; D011461:Prostaglandins F, Synthetic / Q000008:administration & dosage*; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D009883:Ophthalmic Solutions; D010082:Oxepins; D011461:Prostaglandins F, Synthetic; D000077338:Latanoprost; C000607345:propan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoate
keywords: Clinical Trial; Glaucoma; Intraocular pressure