Post-marketing trial of Omidria (phenylephrine + ketorolac injection) finds therapy safe in pediatric cataract surgery- Omeros Corporation

Omeros Corporation announced the successful outcome of its recently completed post-marketing clinical trial of the effect of Omidria (phenylephrine and ketorolac injection) 1% / 0.3% in pediatric patients undergoing cataract surgery. This trial enrolled approximately 70 children aged birth through 3 years undergoing cataract surgery. Patients received either Omidria or phenylephrine added to the irrigation solution used during the surgical procedure. As directed by FDA and because cataracts are relatively rare in children, the trial was powered only to detect common adverse events and was not powered for efficacy.

In the trial, Omidria was safe and well tolerated with adverse event rates consistent with those seen in pediatric cataract surgery and similar in the Omidria and phenylephrine groups. Mean pupil diameter numerically increased following administration of Omidria. Mean postoperative pediatric pain scores of Omidria-treated patients were low (generally less than 0.5 on a scale of 0-10) and were numerically lower in the Omidria group relative to the phenylephrine group.

Comment: Omidria is approved by the FDA for use in adult patients undergoing cataract or intraocular lens replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and is not currently approved for use in patients less than 18 years of age.