Rayner announced the successful completion of its pivotal US dropless cataract surgery study. Omidria (phenylephrine and ketorolac intraocular solution 1% / 0.3%) is the only FDA-approved NSAID for use during cataract surgery, indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative pain, the company said in a press release.
The interim results of this study of 188 eyes found no statistically significant difference in inflammation or mean retinal thickness between the dropless regimen including Omidria, subconjunctival triamcinolone, and intracameral moxifloxacin and standard topical drops on days 1, 8 and 30. Notably, an overwhelming 90% of patients preferred the Omidria regimen compared to 42% for standard eye drops, the company said.
Interim study results were presented at the American Academy of Ophthalmology meeting in Chicago by Drs. Cathleen McCabe, Paul Singh, and Brian Shafer.
The study’s completion delivers a full 90-day data set. The full data set will be presented at the American Society of Cataract and Refractive Surgery annual meeting in Los Angeles. Attendees can register for Rayner’s breakfast symposium here.