Outpatient Surgery Magazine

Answering the Call - May 2020 - Subscribe to Outpatient Surgery Magazine

Outpatient Surgery Magazine, providing current information on Surgical Services, Surgical Facility Administration, Outpatient Surgery News and Trends, OR Excellence and more.

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Page 8 of 110

™ OMIDRIA® and the OMIDRIA logo® are registered trademarks of Omeros Corporation. © Omeros Corporation 2019, all rights reserved. 2019-050 IMPORTANT SAFETY INFORMATION OMIDRIA must be added to irrigating solution prior to intraocular use. OMIDRIA is contraindicated in patients with a known hypersensitivity to any of its ingredients. Systemic exposure of phenylephrine may cause elevations in blood pressure. Use OMIDRIA with caution in individuals who have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory drugs (NSAIDs), or have a past medical history of asthma. The most commonly reported adverse reactions at ≥2% are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation. Please see the Full Prescribing Information for OMIDRIA at www.omidria.com/prescribinginformation. You are encouraged to report Suspected Adverse Reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. References: 1. HCPCS quarterly update. CMS.gov. Available at: https://www.cms.gov/medicare/coding/hcpcsreleasecodesets/hcpcs-quarterly-update.html. Accessed August 9, 2019. 2. Omeros survey data on file. 3. Silverstein SM, Rana V, Stephens R, et al. Effect of phenylephrine 1.0%-ketorolac 0.3% injection on tamsulosin-associated intraoperative floppy-iris syndrome. J Cataract Refract Surg. 2018;44(9):1103-1108. 4. Visco D, et al. Study to evaluate patient outcomes following cataract surgery when using OMIDRIA with postoperative topical NSAID administration versus a standard regimen of postoperative topical NSAIDs and steroids. Presented at: 28th Annual Meeting of the American College of Eye Surgeons (ACES), the American Board of Eye Surgery (ABES), and the Society for Excellence in Eyecare (SEE), Caribbean Eye Meeting; February 1-5, 2019; Cancún, Mexico. 5. Walter K, Kauffman L, Hess J. Rate of pseudophakic cystoid macular edema using intraoperative and topical NSAIDs alone without steroids. Manuscript submitted for publication. 2019. 6. Rosenberg ED, Nattis AS, Alevi D, et al. Visual outcomes, efficacy, and surgical complications associated with intracameral phenylephrine 1.0%/ketorolac 0.3% administered during cataract surgery. Clin Ophthalmol. 2018;12:21-28. 7. Al-Hashimi S, Donaldson K, Davidson R, et al. Medical and surgical management of the small pupil during cataract surgery. J Cataract Refract Surg. 2018;44:1032-1041. 8. Bucci FA Jr, Michalek B, Fluet AT. Comparison of the frequency of use of a pupil expansion device with and without an intracameral phenylephrine and ketorolac injection 1%/0.3% at the time of routine cataract surgery. Clin Ophthalmol. 2017;11:1039-1043. 9. Visco D. Effect of phenylephrine/ketorolac on iris fixation ring use and surgical times in patients at risk of intraoperative miosis. Clin Ophthalmol. 2018;12:301-305. 10. Matossian C, Teves N. Clinical outcomes of phenylephrine/ketorolac intraocular solution versus epinephrine in cataract surgery in a real-world setting. Manuscript submitted for publication. 2018. 11. Walter K, Delwadia N, Coben J. Continuous intracameral phenylephrine-ketorolac irrigation for miosis prevention in femtosecond laser-assisted cataract surgery: reduction in surgical time and iris manipulation. J Cataract Refract Surg. 2019;45(4):465-469. doi: 10.1016/j.jcrs.2018.11.004. 12. Donnenfeld E, Shojaei R. Effect of intracameral phenylephrine and ketorolac 1.0%/0.3% on intraoperative pain and opioid use during cataract surgery. Manuscript submitted for publication. 2019. 13. Gayton JL. Effect of early phenylephrine and ketorolac injection 1% / 0.3% (Omidria®) usage on pupil diameter in traditional and femtosecond laser assisted cataract surgery. E-poster presented at: 15th International Congress on Vision Science and Eye; August 10-11 2017; London, UK. 14. OMIDRIA [package insert]. Seattle, WA: Omeros Corporation; 2017. OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is added to ophthalmic irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. The data are compelling and consistent—OMIDRIA makes cataract surgery better for you and your patients Published and presented clinical data and manuscripts in preparation report that in post-launch (i.e., not included in current labeling), prospective and retrospective, double-masked and open-label, cohort and case-controlled, single and multi-center studies, the use of OMIDRIA statistically significantly: OMIDRIA inhibits the release of inflammation-causing prostaglandins, preventing miosis and reducing postoperative pain 14 OMIDRIA is separately reimbursed under Medicare Part B and by many Medicare Advantage and commercial payers.† Contact your OMIDRIA representative today or visit omidria.com to learn more. † Based on currently available information and subject to change without notice. Individual plan coverage, payment, policies, and procedures may vary and should be confirmed by the facility. Omeros does not guarantee coverage or payment. • Prevents intraoperative fl oppy iris syndrome (IFIS) 3 • Prevents iris prolapse 3 Compared to steroids*: • Reduces cystoid macular edema (CME) 4,5 • Decreases breakthrough iritis 4 • Reduces pain photophobia 4 * OMIDRIA used intraoperatively with postoperative NSAIDs (no steroids) when compared to postoperative steroids with or without NSAIDs (no OMIDRIA). Compared to epinephrine: • Decreases complication rates 6 • Decreases use of pupil-expanding devices (PEDs) 6-11 • Enables performance of surgery and postoperative care without the use of steroids—allowing NSAID-only anti-infl ammatory therapy 4,5,7 • Shortens surgical times 6,7,9,10 • Reduces need for opioids (i.e., fentanyl) during surgery while decreasing VAS pain scores 12 • Prevents miosis during femtosecond laser-assisted surgery 11,13 • Improves uncorrected visual acuity on day after surgery 6 VAS = visual analog scale Less stress, pure success ...in your O.R. day 2 OMIDRIA now has a unique permanent J-code (J1097) 1

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