Eyeworld

EW RESIDENTS 78 May 2017 further peer-reviewed data is avail- able. In summary, this was a well-de- signed study that demonstrated OMS302 to provide predictable and consistent levels of dilation and postoperative pain control; however further studies are needed to com- pare this medication to standard-of- care as well as further cost-benefit analyses. EW References 1. EyeWorld, ed. ASCRS Issues Clinical Alert on Intracameral Alpha Agonists. https://www. eyeworld.org/article-ascrs-issues- clinical-alert-on-intracameral-alpha-agonists. Accessed April 10, 2017. 2. Hoffman RS, Braga-Mele R, Donaldson K, et al. Cataract surgery and nonsteroidal anti- inflammatory drugs. J Cataract Refract Surg. 2016;42(9):1368–1379. 3. Hovanesian JA, Sheppard JD, Trattler WB, et al. Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraop- erative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase 3 studies. J Cataract Refract Surg. 2015;41(10):2060–2068. 4. Lindstrom RL, Loden JC, Walters TR, et al. Intracameral phenylephrine and ketoro- lac injection (OMS302) for maintenance of intraoperative pupil diameter and reduction of postoperative pain in intraocular lens replacement with phacoemulsification. Clin Ophthalmol. 2014;8:1735–1744. 5. Point/Counterpoint: a Disruptive Innovation or a Costly Disruption? Cataract & Refrac- tive Surgery Today http://crstoday.com/ articles/2015-apr/pointcounterpoint-a-dis- ruptive-innovation-or-a-costly-disruption/. Accessed April 10, 2017. 6. Visco D. Use of Iris Fixation Ring With and Without Intracameral Phenylephrine/Ketorolac in Patients with Poor Pupil Dilation. Paper presented at: ASCRS/ASOA Symposium & Congress; May 9, 2016; New Orleans, LA. 7. Rosenberg E, Nattis A, Alevi D, Donnenfeld E. Initial experience, visual outcomes and efficacy of intracameral phenylephrine and ketorolac (1%/0.3%) during cataract surgery. Paper presented at: ASCRS/ASOA Symposium & Congress; May 9, 2016; New Orleans, LA. 8. Walters, T, Schaaf D, Buznego C. Intraca- meral Phenylephrine/Ketorolac to Maintain Pupil Diameter and Reduce Postoperative Pain Regardless of Cataract Surgery Duration. Paper presented at: ASCRS/ASOA Symposium & Congress; May 9, 2016; New Orleans, LA. Contact information Sperber: Laurence.Sperber@nyumc.org cataract surgery as compared to vehicle alone, ketorolac, or phenyl- ephrine, the same superiority was not shown with postoperative ocular pain. The OMS302 treatment group did report a reduction in postoper- ative ocular pain when compared with the vehicle and phenylephrine alone treatment groups, but this was not statistically significant when compared with ketorolac alone. A major strength of this study is that it enrolled participants from 23 study sites across the United States and the characteristics of age, race, and gender were similar between the different treatment groups. Importantly, as consistent with previous trials, OMS302 appeared safe and well-tolerated in this trial with reported adverse events that may be expected following cataract surgery, such as eye pain, headache, and photophobia. No new, unex- pected, or systemic side effects were reported. However, similar to previous clinical trials studying OMS302, the current study omits known high- risk populations such as patients with a history of tamsulosin use and patients with pseudoexfoliation. These patients are most commonly expected to have poor intraoperative mydriasis. While the study excluded these patients, they did include pa- tients who had a history of macular drusen, retinal pigmentary epitheli- um changes, and background diabet- ic retinopathy—conditions that are frequently encountered in practice. Despite good evidence in multiple clinical trials demonstrat- ing efficacy of OMS302, with the ever-present focus on reducing healthcare costs, particularly in the case of Medicare, physicians must keep in mind costs and benefits when utilizing new medications. There have been concerns regarding the cost of utilizing OMS302 for pa- tients, reimbursement to physicians and surgery centers, and the gener- alized cost to the healthcare system. As of Jan. 1, 2015, OMS302 has been granted transitional "pass-through" status, which means Medicare reim- burses for the cost of the medicine separately rather than bundling it with the normal facility fee for cataract surgery. The reimbursement rate is based on the manufacturer's wholesale price, which is currently set at $465 plus a handling fee. Oth- er payers may follow this Centers for Medicare and Medicaid Services policy but are not obligated to do so. This pass-through status is effective until Dec. 31, 2017, at which time it is likely that a separate reimburse- ment fee for OMS302 will stop. It is important to note that utilization of OMS302 does not affect reimburse- ment payment for cataract surgery to the operating surgeon, surgery centers, or to ophthalmologists today or in the future. 5 Lastly, more real-world experi- ence with OMS302 is also required as currently available published data are from controlled trials. Confer- ence proceedings at the 2016 ASCRS annual meeting from independent groups were promising with regards to utilizing OMS302 in patients with intraoperative floppy iris syndrome and patients requiring Malyugin rings or other pupil dilating de- vices. 6,7 Additionally, one group presented encouraging results of OMS302, demonstrating superior mydriasis and pain management regardless of surgical duration. 8 However, caution must be used in interpreting these studies until Review of continued from page 77 OMS302 (intracameral ketorolac and phenylephrine) effect on intraoperative pupil diameter and postoperative pain in cataract surgery Eric D Donnenfeld, MD, J Steven Whitaker, MD, JD, Mitchell A Jackson, MD, John Wittpenn, MD J Cataract Refract Surg. 2017;43(5). Article in press Purpose: To evaluate OMS302 (Omidria [phenylephrine and ketorolac injection] 1% / 0.3%) compared with vehicle, ketorolac alone, and phenylephrine alone on pupil diameter during cataract surgery and on early postoperative ocular pain. Setting: Twenty-three centers in the United States Design: Randomized, double-masked, full-factorial, parallel, Phase 2 trial. Methods: Patients (n=223) were randomized (1:1:1:1) to receive balanced salt solution vehicle, 483 µM phenylephrine only, 89 µM ketorolac only, or OMS302 containing 483 µM phenylephrine and 89 µM ketorolac administered intracamerally during surgery. Surgical pupil diameter was determined at 1-minute intervals by video capture. Postoperative ocular pain was evaluated for up to 12 hours. Results: OMS302 was significantly better than vehicle and ketorolac in maintaining mydriasis (least-squares mean [LSMean] differences ± standard errors were 0.9±0.1 for OMS302 vs. vehicle and 0.7±0.1 for OMS302 vs ketorolac; p<0.0001 each). Postoperative ocular pain assessed by Visual Analog Scale was significantly reduced for OMS302- treated patients compared with vehicle (LSMean difference -4.6±2.2, p=0.042) or phenylephrine (LSMean difference -5.9±2.2, p=0.009). Significantly fewer patients treated with OMS302 (3 [6.1%]) had intraoperative pupil diameter <6 mm compared with those treated with vehicle (25 [47.2%], p<0.0001), ketorolac (18 [34.6%], p=0.0004), or phenylephrine (11 [22.4%], p=0.0216). There was no treatment effect for ocular discomfort, BCVA, and inflammation. Conclusions: In this study, OMS302 was safe and efficacious in maintaining mydriasis and reducing early postoperative ocular pain. Both ketorolac and phenylephrine contributed to the therapeutic effects of the product, with the combination demonstrating superiority to either agent alone in maintaining intraoperative pupil diameter of ≥6mm.

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