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Steve Whitaker, Douglas A Katsev, Gregory A Demopulos, Steven Silverstein, ; Two Phase 3 Trials of Bisulfite- and Preservative-Free OMS302 in Irrigation Solution for Maintenance of Mydriasis, Prevention of Miosis, and Reduction of Postoperative Pain in Intraocular Lens Replacement (ILR). Invest. Ophthalmol. Vis. Sci. 2014;55(13):2550.
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Two Phase 3 trials evaluated the effect of OMS302 (phenylephrine/ketorolac) on intraoperative pupil size and acute postoperative pain in patients undergoing ILR.
Each prospective, randomized, double-masked, placebo-controlled trial enrolled >400 patients, all receiving standard preoperative mydriatic and anesthetic agents. Bisulfite- and preservative-free OMS302 was administered intracamerally in standard irrigation solution delivered throughout the procedure. Patients undergoing cataract extraction and lens replacement or refractive lens exchange were eligible. Patients with conditions that could confound data interpretation, such as iritis, connective tissue disease, or unstable glaucoma were excluded. All procedures were recorded and videos were assessed by a single masked reader. Pupil measurements were taken at the start of the procedure and at one-minute intervals until wound closure. Postoperative pain was measured using a Visual Analog Scale (VAS). Safety was evaluated through 14 days postoperatively.
OMS302 maintained pupil diameter throughout the procedure while the placebo group showed progressive constriction (P<.0001). Fewer OMS302-treated patients than placebo-treated patients experienced: (1) ≥2.5mm pupillary constriction, representing ~50% decrease in the operative field (2% vs 27%; P<.001), and (2) ≤6mm absolute pupil diameter (10% vs 42%; P<.0001). OMS302-treated patients reported significantly less pain than placebo-treated patients in the acute postoperative period, defined as 12 hours post-surgery (P<.0001). Significantly more OMS302-treated than placebo-treated patients reported no pain in the acute postoperative period (26% vs 17%; P=.001). More placebo-treated than OMS302-treated patients reported moderate-to-severe pain (VAS≥40; 14% vs 7%; P=.003). The incidence of adverse events was similar between the treatment groups. The most commonly reported adverse events were eye pain or discomfort, eye inflammation, and headache. No treatment effects on vital signs or ophthalmological examination were observed.
In these Phase 3 trials, OMS302 significantly maintained mydriasis and prevented miosis during ILR. OMS302 also significantly reduced acute postoperative pain. OMS302 was well tolerated.
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