This multicenter, double-masked, randomized trial assessed the efficacy of OMS302 (Omidria) for maintaining adequate pupil diameter during cataract surgery and reducing postoperative pain.
Approved by the FDA in 2014, Omidria (Omeros) contains both phenylephrine 1% and ketorolac 0.3%. The preservative- and bisulfite-free drug is administered continuously as part of irrigation during cataract surgery.
Study design
Conducted in 23 centers across the United States, the trial included 233 patients who were randomized (1:1:1:1) to receive intracamerally administered vehicle, phenylephrine, ketorolac or Omidria during surgery.
Clinicians determined intraoperative pupil diameter each minute by video capture, and evaluated ocular pain 12 hours postoperatively.
Outcomes
Omidira was significantly better than vehicle or ketorolac in maintaining mydriasis during surgery (both P<0.001), and statistically similar to phenylephrine. A post hoc analysis showed that only 6.1% of patients treated with Omidria experienced intraoperative miosis, significantly fewer than those treated with the vehicle (47.2%), ketorolac (34.6%) or phenylephrine (22.4%). For the purposes of this study, miosis was defined as pupil diameter smaller than 6.0 mm at any time during surgery.
Postoperative pain, assessed using the Visual Analog Scale, was also significantly reduced in patients who received Omidria compared with those receiving vehicle or phenylephrine (P=0.042, P=0.009, respectively).
Most adverse events were deemed mild to moderate, with a similar incidence across all 4 groups.
Limitations
The cohort included only noncomplicated cataract cases, and it’s unclear whether cases of intraoperative floppy iris syndrome (IFIS) or pseudoexfoliation would respond similarly.
Clinical significance
Unlike perioperative topical administration of mydriatic agents and NSAIDs, intracameral administration of Omidria delivers constant concentrations of medication into the anterior chamber to effectively target tissues. This well-conducted study demonstrated the therapeutic benefits of Omidria. The administration is also fairly seamless, as shown in this clinical video.