Omeros announced that results of a prospective, controlled study showing that Omidria (phenylephrine and ketorolac intraocular solution) 1%/0.3% reduces use of the opioid fentanyl during cataract surgery while also reducing surgical pain were published in the peer-reviewed journal Clinical Ophthalmology. The article, “The Effect of Phenylephrine/Ketorolac Intracameral Solution 1%/0.3% on Pain and Opioid Use During Cataract Surgery,” is authored by the study investigator Eric D. Donnenfeld, MD, Clinical Professor of Ophthalmology at New York University and recent past president of the American Society of Cataract and Refractive Surgery. Omidria is approved by FDA for prevention of miosis (pupil constriction) 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 (41 patients) or epinephrine (19 patients) 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 percent of Omidria patients requiring fentanyl versus 42.1 percent of epinephrine patients (P=0.006). In addition, mean visual analog scale (VAS of 0-10) pain scores were significantly (48.9 percent) lower in the Omidria group than in the epinephrine group (2.3 vs 4.5; P<0.0001). The proportion of patients with VAS scores ≤ 3 (considered no to minimal pain) was significantly greater in the Omidria group (85.0 percent) than in the epinephrine group (31.6 percent; P<0.0001). Omidria patients also were 94 percent less likely to require fentanyl or to have moderate-to-severe pain (VAS ≥ 4) than patients receiving epinephrine (odds ratio 0.06; 95 percent confidence interval 0.02‑0.24).
“Our study found that Omidria cut intraoperative pain scores in half while markedly reducing the need for fentanyl during cataract surgery,” Dr. Donnenfeld said in a company news release. “Fentanyl is a mainstay of anesthesia during cataract surgery. The ability of Omidria to reduce pain and the need for fentanyl is a welcome advance for cataract surgery patients, a population already at risk for increased exposure to and dependence on opioids. Omidria is the only drug used during cataract surgery that has demonstrated these important benefits.”
Deaths in the U.S. from synthetic opioids, especially fentanyl, have increased more than 10-fold between 2013 and 2018 and are now involved in twice as many deaths as heroin. Reduction of opioid use in cataract surgery patients is a public health focus and many studies have shown that the use of intraoperative opioids is associated with an increased postoperative opioid requirement. Cataract surgery patients who receive an opioid prescription are 1.6 times more likely to be using opioids long-term than those who are not prescribed an opioid following cataract surgery.
“The results of this study represent yet another example of real-world evidence demonstrating the benefits of Omidria,” Gregory A. Demopulos, MD, chairman and chief executive officer of Omeros, said in the news release. “Omeros supports CMS’ intention and Congress’ mandate to remove incentives that lead to increased opioid use, and we are optimistic that CMS will recognize the clear and convincing evidence that packaging Omidria does create such a perverse incentive. Omidria can be readily accessed by veterans as well as commercially insured and Med Advantage patients. We look forward to working with CMS to reduce opioid use and improve patient care by ensuring long-term access to Omidria for Medicare Part B beneficiaries.”
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.