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Evaluation of OMS302 compared to vehicle

Poster Details

First Author: D.Schaaf USA

Co Author(s):    S. Whitaker   G. Demopulos           

Abstract Details

Purpose:

Intraoperative miosis and postoperative pain are two common issues associated with cataract surgery. OMS302, a drug product containing both a mydriatic agent and an NSAID, was developed to address these issues. OMS302 is comprised of phenylephrine hydrochloride, an alpha-1-adrenergic receptor agonist commonly used to achieve preoperative mydriasis, and ketorolac trometamol, a nonsteroidal anti-inflammatory drug often administered topically. A full-factorial design study was performed to evaluate the contribution of each of phenylephrine hydrochloride and ketorolac trometamol to the efficacy of OMS302 on (1) maintenance of pupil diameter during the procedure and (2) postoperative pain.

Setting:

This was a Phase 2, randomized, parallel-group, double-masked, vehicle-controlled study. Twenty-three clinical sites in the United States enrolled subjects undergoing cataract surgery.

Methods:

Subjects were randomized to one of four treatment groups in a 1:1:1:1 fashion: balanced salt solution (BSSĀ®) vehicle, phenylephrine, ketorolac, or OMS302. Randomization was stratified by cataract Lens Opacities Classification System II grade. Study treatment was diluted in BSS and administered as irrigation solution to the anterior chamber of the eye during the cataract surgery procedure. Maintenance of mydriasis was determined by video capture at one-minute intervals intraoperatively, and postoperative ocular pain was evaluated using a Visual Analog Scale (VAS). Commonly administered preoperative mydriatic and analgesic agents as well as pre- and postoperative antibiotic medications were standardized for all subjects.

Results:

Subjects were randomized: 56 vehicle, 55 ketorolac, 56 phenylephrine, 55 and OMS302. OMS302 was superior to both vehicle and ketorolac in maintaining mydriasis during the procedure. The least-squares mean difference (standard error [SE]) between OMS302 and vehicle was 0.9 (0.1), p<0.0001; between OMS302 and ketorolac the difference was 0.7 (0.1), p<0.0001. Postoperative pain was statistically reduced among OMS302 subjects compared to vehicle and phenylephrine subjects. The mean difference (SE) between OMS302 and vehicle was -4.6 (2.2), p=0.0421; between OMS302 and phenylephrine the difference was -5.9 (2.2), p=0.0093. Adverse events experienced were those commonly associated with cataract surgery.

Conclusions:

OMS302-treated subjects had significantly improved maintenance of pupil diameter compared to ketorolac- and vehicle-treated subjects and significantly reduced postoperative ocular pain compared to phenylephrine- and vehicle-treated subjects. The results of this study demonstrated the contribution of phenylephrine to the maintenance of pupil diameter and that of ketorolac to the prevention of early postoperative ocular pain. OMS302 was safe and well-tolerated.

Financial Disclosure:

One or more of the authors gains financially from product or procedure presented, One or more of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors is employed by a for-profit company with an interest in the subject of the presentation, One or more of the authors has significant investment interest in a company producing, developing or supplying product or procedure presented

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