Omeros (OMER) Announces Successful Results from OMIDRIA Post-Marketing Trial in Cataract Surgery
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Omeros Corporation (Nasdaq: OMER) 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. 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.
This pediatric 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.
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 (sNDA) 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.
“We’re pleased with the positive results of this trial, in which OMIDRIA was shown to be safe and well tolerated in children and provides benefits in this younger population consistent with those in adults,” stated Gregory A. Demopulos, M.D., chairman and chief executive officer of Omeros. “We look forward to receiving extended patent exclusivity for OMIDRIA and to expanding its label to include pediatric patients without age limitation.”
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