September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Ocular hypotensive effects and tolerability of the novel dual EP3/FP receptor agonist ONO-9054 vs. Xalatan®: Results of a 28 day, double masked, randomized, active comparator study in open angle glaucoma (OAG) and ocular hypertension (OHT)
Author Affiliations & Notes
  • Eydie G Miller-Ellis
    Ophthalmology, Scheie Eye Institute, Philadelphia, Pennsylvania, United States
  • Michael S. Berlin
    Glaucoma Institute, Beverly Hills, California, United States
    Jules Stein Eye Institute, Los Angeles, California, United States
  • Caroline L Ward
    Ono Pharma, Cambridge, United Kingdom
  • John Sharpe
    Ono Pharma, Cambridge, United Kingdom
  • Alam Jamil
    Ono Pharma, Cambridge, United Kingdom
  • Alon Harris
    Indiana University School of Medicine, Indianapolis, Indiana, United States
  • Footnotes
    Commercial Relationships   Eydie Miller-Ellis, Alcon (C), Allergan (C), Allergan (F), Ono Pharma (C); Michael S. Berlin, Allergan (C), Ono Pharma (C), Santen (C); Caroline Ward, Ono Pharma (E); John Sharpe, Ono Pharma (E); Alam Jamil, Ono Pharma (E); Alon Harris, AdOM (C), AdOM (I), Biolight (C), Isama Therapeutics (C), Nano retina (C), Ono Pharma (C), Oxymap (I), Science Based Health (C), Stemnion, Inc (C)
  • Footnotes
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Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Eydie G Miller-Ellis, Michael S. Berlin, Caroline L Ward, John Sharpe, Alam Jamil, Alon Harris; Ocular hypotensive effects and tolerability of the novel dual EP3/FP receptor agonist ONO-9054 vs. Xalatan®: Results of a 28 day, double masked, randomized, active comparator study in open angle glaucoma (OAG) and ocular hypertension (OHT). Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : It was hypothesized that ONO-9054, a potent dual EP3/FP prostanoid receptor agonist, might provide a greater and more sustained reduction in IOP than the FP agonist latanoprost. This Phase II study compared the effects of once daily evening (22:00) dosing of ONO-9054 (0.003%, 30 μg/mL) to latanoprost (Xalatan®; 0.005%, 50 μg/mL) in mild to moderate OAG or OHT.

Methods : Adults with un-medicated IOP ≥ 24 mmHg at 8:00 AM and ≥ 21mmHg at 10:00 AM were randomized 1:1 to ONO-9054 or Xalatan®. Exclusion criteria included: history of severe ocular trauma; narrow angles grade ≤ 2. Study powered (≥ 80%) to detect a difference between treatments at the significance level of 0.05.

Results : 62 Subjects randomized to ONO-9054 and 61 to Xalatan®. There were 37 adverse events (AEs) in 22 ONO-9054 subjects and 35 AEs in 18 Xalatan® subjects; all mild or moderate in intensity. One unrelated SAE (NAION) occurred in a subject randomized to receive ONO-9054. Tolerability scores were similar between the groups. Individual subject hyperemia scores were similar between ONO-9054 and Xalatan® groups, however, the number of hyperemia AEs reported for ONO-9054 was higher than reported for Xalatan® (19.4% vs 8.2%). Hyperemia AEs in both groups resolved without sequelae and hyperemia symptoms had returned to baseline levels by follow-up.
ONO-9054 achieved a greater reduction in mean diurnal IOP at Day 29 (08:00, 10:00, 12:00 and 16:00; mean reduction -7.2 mmHg vs. -6.6 mmHg) but this was not statistically significant. Statistical significance was achieved at Day 29 at 10:00, 12:00, 16:00 and 20:00 combined (P<0.05, post hoc analysis). Both treatments were similarly effective at the 08:00 hour assessment but there was a greater and more prolonged effect for ONO 9054 compared to Xalatan® throughout the day. At 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 for Xalatan® [P<0.05, post hoc analysis]. The odds of achieving a target IOP ≤15 mmHg for ONO-9054 were 2.4 times more than for Xalatan® [P<0.01, post hoc analysis].

Conclusions : Subjects randomized to receive ONO-9054 were more likely to achieve a significantly larger reduction in IOP with longer duration of efficacy than those receiving Xalatan®.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

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