Eyeworld

107 EW RESIDENTS October 2015 of pupil diameter. In addition, only 9.8% of patients who underwent cataract surgery supplemented with OMS302 had a pupil diameter of <6 mm at any time during surgery, while 42.4% of patients receiving placebo had a pupil diameter of <6 mm at some point during the case. The percentage of pupils undergoing constriction of more than 2.5 mm throughout surgery was significantly less in patients receiving OMS302 (2.1%) when compared to those Results In this highly controlled popula- tion of patients undergoing lens extraction with few risk factors for poor mydriasis, the authors found that OMS302 was superior to place- bo in maintaining mydriasis during cataract surgery. They reported a statistically significant difference in pupil diameter throughout cataract extraction between the OMS302 and the placebo groups. Throughout the procedure, the OMS302 group had an average increase in pupil diam- eter of 0.08 mm while the placebo group had a 0.50 mm constriction (OMS302) during cataract postoperative ocular pain continued on page 108 Intracameral phenylephrine and ketorolac (OMS302) during cataract surgery maintains intraoperative mydriasis and reduces postoperative ocular pain – integrated results from two pivotal phase 3 studies John A. Hovanesian, MD, John D. Sheppard, MD, William B. Trattler, MD, Johnny L. Gayton, MD, Ranjan P. Malhotra, MD, David Schaaf, MD, Edmund Ng, PhD, Steven H. Dunn, MD J Cataract Refract Surg (Oct.) 2015;41. Article in press Purpose: To evaluate the efficacy and safety of OMS302 (Omidria [phenylephrine and ketorolac injection] 1%/0.3%, Omeros, Seattle) for maintenance of mydriasis during, and reduction of ocular pain following, cataract surgery. Setting: 20 centers in the United States and Netherlands Design: Two phase 3, pivotal, randomized, double-masked, placebo- controlled, multicenter studies Methods: A total of 808 subjects (403 OMS302 and 405 placebo) undergoing cataract extraction and lens replacement or refractive lens exchange were enrolled in two separate clinical studies. OMS302 or placebo was administered intracamerally as part of standard irrigation solution during the procedure. Integrated analyses of two co-primary endpoints, intraoperative change in pupil diameter and postoperative subject-reported ocular pain, were conducted. Results: OMS302 was superior to placebo for the maintenance of mydriasis during, and reduction of ocular pain following, cataract surgery. The mean area-under-the-curve (AUC) change from baseline in pupil diameter was 0.08 mm for OMS302 compared to –0.50 mm for placebo (p<0.0001). Mean AUC of subject ocular pain visual analog scale (VAS) scores within 12 hours postoperatively were more than 50% lower for OMS302 (mean AUC=4.16 mm) than placebo (mean AUC=9.06 mm, p<0.001). Results of all secondary efficacy analyses demonstrated a significant treatment effect associated with OMS302. Treatment- emergent adverse events were as expected for a population undergoing cataract surgery; no clinically significant differences in safety measures were observed between treatment groups. Conclusions: In this integrated analysis, OMS302 administered intracamerally with irrigation solution during cataract surgery was safe and effective for maintaining mydriasis during the procedure and reducing postoperative ocular pain.

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