Omeros announces successful outcome of OMIDRIA pediatric cataract trial
Omeros announced the successful outcome of its recently completed post-marketing clinical trial of the effect of OMIDRIA 1% / 0.3% in pediatric patients undergoing cataract surgery. 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 and to reduce postoperative ocular pain and is not currently approved for use in patients less than 18 years of age. The pediatric trial was undertaken as an FDA post-marketing requirement under the Pediatric Research Equity Act and in fulfillment of FDA's Written Request provided under the Best Pharmaceuticals for Children Act. Successful completion of the trial, including submission of a supplemental New Drug Application that includes the full clinical study report and proposed labeling, fulfills the post-marketing requirement and results in eligibility for an additional 6 months of marketing exclusivity for OMIDRIA as well as label expansion to include information on dosing for pediatric patients. Following FDA's review of the sNDA, the FDA-approved indication and labeling for OMIDRIA will be updated to reflect the trial results. Although conducted in patients newborn to 3 years old, the FDA agreed that results from this trial can be extrapolated to patients through 18 years of age, and a label expansion would be expected to be applicable to that full age range. Gregory Demopulos, M.D., chairman and CEO of Omeros, said, "We look forward to receiving extended patent exclusivity for OMIDRIA and to expanding its label to include pediatric patients without age limitation."