Omeros publishes results showing Omidria reduces fetanyl use in cataract surgery
Omeros announced that results of a prospective, controlled study showing that its FDA-approved ophthalmic drug Omidria reduces use of the opioid fentanyl during cataract surgery while also reducing surgical pain were published in the peer-reviewed journal Clinical Ophthalmology. Omidria is approved by FDA for prevention of miosis and for reduction in postoperative pain for adults and pediatric patients undergoing cataract or lens replacement surgery. The study objectives were to evaluate the effect of Omidria compared to epinephrine on perioperative fentanyl use and pain in patients undergoing cataract surgery. Sixty patients were prospectively assigned to have either Omidria or epinephrine added to the irrigation solution used during surgery. Patients in the Omidria group were 6.7 times more likely not to require fentanyl, with 9.8% of Omidria patients requiring fentanyl versus 42.1% of epinephrine patients. In addition, mean visual analog scale pain scores were significantly lower in the Omidria group than in the epinephrine group. The proportion of patients with VAS scores of 3 was significantly greater in the Omidria group than in the epinephrine group. Omidria patients also were 94% less likely to require fentanyl or to have moderate-to-severe pain than patients receiving epinephrine. Congress and CMS understand the public health risk associated with opioid exposure and CMS is required under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment, or SUPPORT, for Patients and Communities Act to review payments under its outpatient prospective payment system for opioids and evidence-based non-opioid alternatives for pain management with a goal of ensuring that there are not financial incentives to use opioids instead of non-opioid alternatives. In its 2020 OPPS final rule published on November 1, CMS did not add any products to the non-opioid exclusion from packaged payment. Although CMS had received an analysis of the Donnenfeld data, CMS specifically requested peer-reviewed published evidence and the Donnenfeld study had not yet been published at the time the final rule was issued. With the publication of the Donnenfeld opioid-sparing data, Omeros believes that Omidria meets all of CMS' requirements for the non-opioid exclusion. CMS stated in the final rule that it will continue to analyze the evidence in support of the benefits of Omidria and monitor utilization of this drug, and Omeros intends to address CMS' Omidria-related comments. Omeros also plans to continue its administrative and legislative efforts to secure ongoing separate payment for Omidria beyond the drug's current pass-through extension. Omidria continues to receive separate payment from CMS under its pass-through extension until October 1, 2020.