NOV 22, 2016
Omeros says its recently completed post-marketing clinical trial for Omidria demonstrates it is safe for use in pediatric cataract surgery to prevent intraoperative miosis and reduce postoperative pain.
The combination drug (phenylephrine 1.0%, ketorolac 0.3%) is already FDA approved for adult cataract surgery patients, but it is not currently approved for use in patients younger than age 18.
More than 70 children, newborns to age 3, were enrolled. Either Omidria or phenylephrine alone was added to the irrigation solution during cataract surgery.
Overall, the drug was safe and well tolerated with adverse event rates similar between both groups and consistent with those seen in pediatric cataract surgery. Although the FDA did not require the study to be powered for efficacy, the company states that mean pupil size increased following administration of Omidria, and mean postoperative pain scores were numerically lower in the Omidria group compared with the phenylephrine group.
Omeros has submitted the clinical study report as part of a supplemental New Drug Application (sNDA), thereby fulfilling the post-marketing requirement for label expansion to include pediatric dosing information as well as an additional 6 months of marketing exclusivity for Omidria. Despite the limited age range of patients enrolled in the trial, the FDA has stated that the results may be extrapolated for patients up to 18 years of age. Pending review of the sNDA, Omidria will be approved for use in all ages.