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The effect of preservative-free/bisulfite-free OMS302 added to irrigation fluid on intraoperative pupil diameter during intraocular lens replacement surgery

Session Details

Session Title: Cataract I

Session Date/Time: Friday 14/02/2014 | 10:30-12:30

Paper Time: 11:10

Venue: Kosovel Hall (Level -2)

First Author: : KhiunTjia THE NETHERLANDS

Co Author(s): :    Steve Whitaker              

Abstract Details

"Purpose:

The purpose of this study was to evaluate the effect of OMS302 on intraoperative pupil size during cataract and clear lens procedures (collectively, intraocular lens replacement [ILR]). Maintenance of mydriasis as well as two measures of miosis were prospectively defined and analyzed. OMS302 is an investigational drug containing phenylephrine (PE) and ketorolac administered intracamerally in irrigation fluid.

Setting:

Three multicentre clinical trials

Methods:

Data from one Phase 2 (C09-001) and two Phase 3 (ILR-003 and ILR-004) clinical trials are included in this study. These trials evaluated the effects of OMS302 on maintenance of mydriasis and prevention of miosis intraoperatively, and reduction of acute postoperative pain. Although not detailed in this abstract, OMS302 was statistically superior to placebo in reduction of acute postoperative pain, percentage of subjects reporting moderate-to-severe pain, and the percentage of subjects who were pain-free at all assessments during the early postoperative period. Each clinical trial was randomized, double-masked, and vehicle- (C09-001) or placebo-controlled (ILR-003 and ILR-004). Patients undergoing unilateral ILR with monofocal or premium lenses were eligible. Preoperatively, all subjects received standardized topical PE, tropicamide and an anesthetic agent (lidocaine or tetracaine). Study drug was delivered only intraoperatively in the irrigation solution. Intraoperative pupil diameter was captured on video and measured using ImageJ software by a single, masked, central reader. Pupil diameter was measured every minute intraoperatively. All analyses are intent to treat. Safety and tolerability were evaluated by adverse events, vital signs and ocular examinations for 14 to 90 days postoperatively.

Results:

Nine hundred and nineteen subjects were randomized to OMS302 ( N=458) or vehicle/placebo (N=461) in these trials. Pupil diameter was maintained in the OMS302 group while placebo patients experienced steady pupil constriction during the procedures. The difference in the mean AUCs between placebo and OMS302 was 0.60 (p < 0.0001). OMS302 was also superior to placebo/vehicle in prevention of intraoperative miosis defined as an absolute pupil diameter of less than 6 mm or pupil constriction of at least 2.5 mm. These definitions of miosis were chosen because a pupil diameter of less than 6 mm is associated with an increased risk of complications and pupil constriction of 2.5 mm represented a decrease of approximately 50% in total pupillary area. Forty-three percent of placebo/vehicle treated subjects experienced a pupil diameter < 6 mm compared to 9% of OMS302-treated subjects (p<0.0001). Twenty-seven percent of placebo/vehicle-treated subjects experienced pupil constriction ≤ 2.5 mm compared to 2% on OMS302 (p<0.0001). The most commonly reported adverse events (≥ 5% in either treatment group) were eye pain, eye inflammation, headache, and ocular.

Conclusions:

In this study, OMS302 maintained intraoperative mydriasis and prevented intraoperative miosis compared to placebo in the setting of all patients receiving standard preoperative mydriatic and anesthetic agents. OMS302 was well tolerated. FINANCIAL INTEREST: ... gains financially from product or procedure presented, ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... is employed by a for-profit company with an interest in the subject of the presentation"