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OMIDRIA™: FDA approved for adult cataract surgery patients

Important Safety Information

OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% must be added to irrigation 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 non-steroidal anti-inflammatory drugs (NSAIDs), or have a past medical history of asthma.

The most commonly reported adverse reactions at 2-24% are eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation.

Use of OMIDRIA in children has not been established.

Please see the Full Prescribing Information for OMIDRIA.

You are encouraged to report Suspected Adverse Reactions to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Indications and Usage

OMIDRIA is added to ophthalmic irrigation 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.

OMEROS®, the OMEROS logo®, OMIDRIA®, and the OMIDRIA logo® are registered trademarks, and OMIDRIAssure™ is a trademark, of Omeros Corporation.
© Omeros Corporation 2016, all rights reserved. 2016-059
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References
  1. OMIDRIA [package insert]. Seattle, WA: Omeros Corporation; 2014.
  2. Flach AJ. Intraoperative floppy iris syndrome: pathophysiology, prevention, and treatment. Trans Am Ophthalmol Soc. 2009;107:234-239.
  3. Donnenfeld E. Current use of non-steroidal anti-inflammatory drugs in the treatment of ocular inflammation related to cataract surgery. Eur Ophthalmic Rev. 2012;6(3):173 177.
  4. Grob SR, Gonzalez-Gonzalez LA, Daly MK. Management of mydriasis and pain in cataract and intraocular lens surgery: review of current medications and future directions. Clin Ophthalmol. 2014;8:1281-1289.
  5. Katsev D, Katsev C, Pinnow J. Intracameral Ketorolac Concentration After Topical Ketorolac Administration Prior to Cataract Surgery. Electronic poster session presented at: American Society of Cataract and Refractive Surgery. 2015 ASCRS-ASOA Symposium and Congress; 2015 Apr 17-21; San Diego, CA.
  6. 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.
  7. Porela-Tiihonen S, Kaarniranta K, Kokki M, Purhonen S, Kokki H. A prospective study on postoperative pain after cataract surgery. Clin Ophthalmol. 2013;7:1429-1435.
  8. Myers WG, Edelhauser HF. Shortage of bisulfite-free preservative-free epinephrine for intracameral use. J Cataract Refract Surg. 2011;37(3):611.
  9. Cutler Peck CM, Brubaker J, Clouser S, et al. Toxic anterior segment syndrome: common causes. J Cataract Refract Surg. 2010;36(7):1073-1080.
  10. Tu EY. Balancing antimicrobial efficacy and toxicity of currently available topical ophthalmic preservatives. Saudi J Ophthalmol. 2014;28(3):182-187.
  11. US Food and Drug Administration. Compounding and the FDA: Questions and Answers. http://www.fda.gov/Drugs/ GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339764.htm#approved. Accessed January 13, 2015.
  12. US Department of Health and Human Services. Guidance, Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act. Silver Spring, MD: Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2014. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377052.pdf. Accessed August 28,2014.
  13. US Department of Health and Human Services. Guidance for Industry, Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act. Silver Spring, MD: Food and Drug Administration, Center for Drug Evaluation and Research (CDER); 2013. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377051.pdf. Accessed August 28, 2014.
  14. Compounding: inspections, recalls, and other actions. U.S. Food and Drug Administration Web site. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm339771.htm. Accessed January 5, 2015.
  15. Shaw J. Coping with the epinephrine shortage. EyeNet Magazine. June 2013;29-31. http://www.aao.org/publications/eyenet/201306/cataract.cfm?RenderForPrint=1. Accessed March 12, 2015.
  16. Department of Health and Human Services. Centers for Medicare & Medicaid Services. January 2015 Update of the Hospital Outpatient Prospective Payment System (OPPS). MLN Matters Number:MM9014. Revised December 23, 2014.
  17. Omeros, data on file
  18. Hovanesian JA, Sheppard JD, Trattler WB, et al. Intracameral phenylephrine and ketorolac (OMS302) during cataract surgery maintains intraoperative mydriasis and reduces postoperative ocular pain – integrated results from two pivotal phase 3 studies. J Cataract Refract Surg. In press 2015.