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Omeros completes enrollment in pediatric clinical trial of Omidria
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Omeros has completed patient enrollment in a post-marketing pediatric clinical trial of Omidria, according to a press release.
As an FDA post-marketing requirement, the company has enrolled 70 cataract surgery patients between 0 and 3 years of age. Upon successful completion of the clinical trial, Omeros will be eligible to receive an additional 6 months of marketing exclusivity for Omidria (phenylephrine 1% and ketorolac 0.3% injection).
“We expect that the trial results will provide important information on the role of Omidria in pediatric patients and look forward to submitting the data to FDA to meet the criteria required for additional marketing exclusivity.” Gregory A. Demopulos, MD, chairman and CEO of Omeros, said in the release.
The company is conducting the trial in compliance with FDA regulations and within the specified timelines.