June 2013
Volume 54, Issue 15
Free
ARVO Annual Meeting Abstract  |   June 2013
Safety and tolerability following single dose of ONO-9054 in healthy volunteers
Author Affiliations & Notes
  • Cheryl Rowe-Rendleman
    Pre-Clinical, Ono Pharma/Omar Consulting Grp LLC, Princeton Junction, NJ
  • Takafumi Ouchi
    Drug Development, Ono Pharma USA, Lawrenceville, NJ
  • Douglas Ross
    Drug Development, Ono Pharma USA, Lawrenceville, NJ
  • Andrew Wood
    Drug Development, Ono Pharma USA, Lawrenceville, NJ
Investigative Ophthalmology & Visual Science June 2013, Vol.54, 440. doi:
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    • Get Citation

      Cheryl Rowe-Rendleman, Takafumi Ouchi, Douglas Ross, Andrew Wood; Safety and tolerability following single dose of ONO-9054 in healthy volunteers. Invest. Ophthalmol. Vis. Sci. 2013;54(15):440.

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

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Abstract

Purpose: ONO-9054 (Ono Pharmaceuticals, Osaka Japan) is a novel ocular hypotensive compound and is the isopropyl ester derivative of the free acid ONO AG-367 a dual FP/EP3 agonist that may be effective in lowering intraocular pressure in humans. The safety and tolerability of the compound was evaluated after instillation of a single drop

Methods: A randomized, double-masked, placebo controlled clinical trial (NCT01508988) was conducted with 48 healthy volunteers who received a single dose of ONO-9054 q.d. ranging in concentration from 0.3-30 ug/mL. Safety parameters were evaluated from predose through 7 days after dosing. Safety evaluations included adverse events, vital signs, spirometry, electrocardiogram, clinical laboratories, ocular tolerability and hyperemia.

Results: All subjects were between the ages of 18-64. Overall, 10 AEs were reported across all doses (0.3-30 µg/mL) from subjects who received ONO-9054. Similarly 7 AEs were reported from subjects who received placebo. There were no dose related trends in incidence or intensity of any ocular AEs including flare. All AEs observed in ONO-9054 group were mild in nature. The majority of responses for eyedrop tolerability were rated as absent or mild. Itching was the most frequently reported symptom with similar frequencies in the placebo group. All hyperemia was transient and resolved to baseline levels by 49 hours postdose.

Conclusions: Ocular safety findings showed that ONO-9054 was well tolerated. Overall, there was no apparent dose-response in any systemic or local tolerability parameters. These early results support the rationale for additional clinical trials to demonstrate the safety and evaluate the efficacy of ONO-9054 ophthalmic solution in randomized, controlled, multiple dose clinical trials.

Keywords: 466 clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • 675 receptors: pharmacology/physiology • 503 drug toxicity/drug effects  
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