Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan

Results of a 28-day, double-masked, randomised study

Eydie Miller Ellis, Michael S. Berlin, Caroline L. Ward, John A. Sharpe, Alam Jamil, Alon Harris

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Background/aims 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. Methods 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. Results 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 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). Conclusions 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.

Original languageEnglish (US)
JournalBritish Journal of Ophthalmology
DOIs
StateAccepted/In press - Sep 20 2016

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latanoprost
Double-Blind Method
Intraocular Pressure
Ocular Hypertension
Open Angle Glaucoma
propan-2-yl 4-(6-(4-(2,5-difluorophenoxy)-3-hydroxybut-1-en-1-yl)-7-hydroxyoctahydro-2H-cyclopenta(b)oxepin-3-yl)butanoate

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan : Results of a 28-day, double-masked, randomised study. / Ellis, Eydie Miller; Berlin, Michael S.; Ward, Caroline L.; Sharpe, John A.; Jamil, Alam; Harris, Alon.

In: British Journal of Ophthalmology, 20.09.2016.

Research output: Contribution to journalArticle

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title = "Ocular hypotensive effect of the novel EP3/FP agonist ONO-9054 versus Xalatan: Results of a 28-day, double-masked, randomised study",
abstract = "Background/aims 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. Methods 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. Results 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 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). Conclusions 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.",
author = "Ellis, {Eydie Miller} and Berlin, {Michael S.} and Ward, {Caroline L.} and Sharpe, {John A.} and Alam Jamil and Alon Harris",
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T2 - Results of a 28-day, double-masked, randomised study

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AU - Berlin, Michael S.

AU - Ward, Caroline L.

AU - Sharpe, John A.

AU - Jamil, Alam

AU - Harris, Alon

PY - 2016/9/20

Y1 - 2016/9/20

N2 - Background/aims 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. Methods 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. Results 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 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). Conclusions 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.

AB - Background/aims 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. Methods 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. Results 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 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). Conclusions 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.

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