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A drug that has been developed for use via injection for cataract surgery purposes in the United States has just received approval for use by the United States Food & Drug Administration. Omidria is designed to be a pupil dilating agent and anti-inflammatory agent that after important clinical trials that used a standard drug for such purposes showed a significant improvement and more importantly an improvement that was clinically meaningful in the prevention of miosis and relieving post operative pain after surgery when compared to a placebo.While approval has been granted it is not for use in pediatric surgery and must only be used when diluted. It is noted that the the dilating agent, phenylephrine, can create high blood pressure in patients after systemic exposure.
With only the pediatric restraint imposed upon its license then the drug will be eligible for an additional 6 months of marketing exclusivity in the United States alone. The drug is hoped to give more control to surgeons to control the post operative pain for their patients and improve overall surgical outcomes.