Challenges in cataract surgery

Miosis compromises visualization of the operative field

  • Intraoperative miosis* increases the risk of capsule tear, vitreous loss, retained lens fragments, iris damage and improper IOL placement8
  • Miosis is unpredictable, even in patients who do not have risk factors9,10
  • Dealing with miosis can be costly, worsen outcomes, and prolong surgical time11

*Pupil <6.0 mm.

When pupil diameter decreases, the operative field decreases exponentially

Preoperative topical medication is often washed out after irrigating the eye

  • 100% of patients who received preoperative topical ketorolac had nominal or undetectable ketorolac levels at the end of the procedure12
  • Below the lower limit of quantification (<1 ng/mL) in 8 of 12 evaluable patients
  • Nominal and clinically irrelevant (1.80 ng/mL to 6.32 ng/mL) in 4 of 12 evaluable patients
  • Preoperative topical mydriatics can lose effectiveness in some patients4
Study of ketorolac levels in aqueous humor of 14 patients at the start and end of cataract surgery following multiday preoperative topical ketorolac administration. Results from the 12 patients for whom aqueous humor samples were available.

Despite common belief, cataract surgery patients can experience significant postoperative pain

  • Up to 35% of patients have been shown to experience moderate to severe pain during the first hours following cataract surgery13

Opioids are currently part of some pain-management regimens in cataract surgery5

Learn More About OMIDRIA
IMPORTANT SAFETY INFORMATION
Indications and Usage

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.

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 to phenylephrine may cause elevations in blood pressure.

Systemic exposure to 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.

OMEROS®, the OMEROS logo®, OMIDRIA®, the OMIDRIA logo®, and OMIDRIAssure® are registered trademarks of Omeros Corporation.
© Omeros Corporation 2021, all rights reserved. US-OM-2100051

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References
  1. Omeros survey data on file.
  2. 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. 2017;12:21-28.
  3. OMIDRIA [package insert]. Seattle, WA: Omeros Corporation; 2017.
  4. Lindstrom RL, Loden JC, Walters TR, et al. Intracameral phenylephrine and ketorolac 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. Hovanesian JA, Sheppard JD, Trattler WB, et al. Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: integrated results from 2 pivotal phase 3 studies. J Cataract Refract Surg. 2015;41:2060-2068.
  6. Donnenfeld ED, Whitaker JS, Jackson MA, Wittpenn J. Intracameral ketorolac and phenylephrine effect on intraoperative pupil diameter and postoperative pain in cataract surgery. J Cataract Refract Surg. 2017;43:597-605.
  7. HCPCS quarterly update. CMS.gov. Available at: https://www.cms.gov/medicare/coding/hcpcsreleasecodesets/hcpcs-quarterly-update.html. Accessed August 9, 2019.
  8. Guzek JP, Holm M. Cotter JB, et al. Risk factors for intraoperative complications in 1000 extracapsular cataract cases. Ophthalmol. 1987;94(5):461-466.
  9. Roach L. Strategies for preventing intraoperative miosis. EyeNet. 2015:29-31.
  10. Chang DF, Campbell JR, Colin J, Schweitzer C. Prospective masked comparison of intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmol. 2014;121:829-834.
  11. Ackman A, Yilmaz G, Oto S, Akova YA. Comparison of various pupil dilatation methods for phacoemulsification in eyes with a small pupil secondary to pseudoexfoliation. Ophthalmol. 2004;111:1693-1698.
  12. Katsev DA, Katsev CC, Pinnow J, Lockhart CM. Intracameral ketorolac concentration at the beginning and end of cataract surgery following preoperative topical ketorolac administration. Clin Ophthalmol. 2017;11:1897-1901.
  13. Porela-Tiihonen S, Kaarniranta K, Kokki M. Postoperative pain after cataract surgery. J Cataract Refract Surg. 2013;39:789-798.
  14. Omeros data on file.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. Matossian C. Clinical and economic outcomes in cataract surgery using phenylephrine 1.0%-ketorolac 0.3% in a real-world setting. Presented at: American Society of Cataract and Refractive Surgery – American Society of Ophthalmic Administrators Symposium & Congress (ASCRS-ASOA). April 13-17, 2018. Washington, D.C.
  20. 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; 2017 Aug 10-11; London, UK.
  21. Waterbury LD. Alternative drug delivery for patients undergoing cataract surgery as demonstrated in a canine model. J Ocul Pharmacol Ther. 2018;34:154-160.
  22. Visco DM, Bedi R. Effect of intracameral phenylephrine 1.0%–ketorolac 0.3% on postoperative cystoid macular edema, iritis, pain, and photophobia after cataract surgery. J Cataract Refract Surg. 2020;46:867–872.
  23. Walter K, Kauffman L, Hess J. Rate of pseudophakic cystoid macular edema using intraoperative and topical nonsteroidal antiinflammatory drugs alone without steroids. J Cataract Refract Surg. 2020;46:350–354.
  24. Data on file.
  25. Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs. Baltimore, MD: Centers for Medicare and Medicaid Services, U.S. Department of Health and Human Services; December 2, 2020. CMS publications CMS-1736-FC and 1736-IFC.
  26. CY 2021 Medicare Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System Final Rule (CMS-1736-FC).
  27. Centers for Medicare & Medicaid Services website. https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/HospitalOutpatientPPS/Addendum-A-and-Addendum-B-Updates. Accessed September 7th 2021
  28. Kaiser Family Foundation analysis of Centers for Medicare and Medicaid Services 2016 Medicare Current Beneficiary Survey.