Experience less stress1 in your O.R. day and deliver better outcomes for your patients

The data are compelling and consistent–OMIDRIA makes cataract surgery better for you and your patients

Published and presented clinical studies 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 analyses, the use of OMIDRIA, compared to the surgeons’ standard of care, statistically significantly:
  • Prevents Intraoperative Floppy Iris Syndrome (IFIS)14
  • Reduces complication rates (epinephrine comparator)2
  • Decreases use of pupil-expanding devices (epinephrine comparator)2,7,15-18
  • Reduces surgical times (epinephrine comparator)2,7,15,18
  • Prevents miosis during femtosecond laser-assisted surgery (epinephrine comparator)17,19
  • Improves uncorrected visual acuity on day after surgery (epinephrine comparator)2
  • Delivers NSAID to the anterior chamber and related structures better than routine preoperative topical drug administration, resulting in effectively complete postoperative inhibition of COX-1 and COX-211,20

Reduces complication rates2

Patients who received OMIDRIA had fewer intraoperative and postoperative complications, including capsular tears, lens decentration, retained lens fragments, macular puckering, and retinal detachment.

Retrospective case review. Co-author E. Donnenfeld is a consultant for Omeros.

Reduces surgical time and pupil-expanding device use18

In the OMIDRIA group, use of pupil-expanding devices (PED) was reduced by 67% and surgical time was reduced by 7.3%.

Retrospective case review, single surgeon, two centers. Omeros Corporation provided support for this study. C. Matossian is a consultant for Omeros.

Reduces use of pupil-expanding devices in high-risk patients and in femtosecond laser surgery15,17

With OMIDRIA, zero patients at risk for intraoperative miosis* required pupil-expanding devices.

  • Additionally, mean surgical time with OMIDRIA was significantly shorter compared to epinephrine (10.1 vs 14.3 minutes; p=0.0068) in high-risk patients

Retrospective case review analysis of patients at risk for requiring a pupil-expanding device. Dr Visco is a consultant for Omeros Corporation, which provided financial support for this study.

* Patients with presurgical examination of pupil dilation ≤5.0 mm after being administered topical tropicamide 1% and phenylephrine 2.5% or history of IFIS during surgery in the fellow eye.15

With OMIDRIA, there was an 83% reduction in pupil-expanding device usage in femtosecond laser surgeries.

  • Additionally, mean surgical time with OMIDRIA was significantly shorter compared to epinephrine (8.10 vs 9.39 minutes; p=0.007) in femtosecond laser-assisted cataract surgeries

Retrospective case review analysis of patients undergoing femtosecond laser-assisted cataract surgery. Dr Walter is a consultant for Omeros Corporation.

Prevents IFIS14

The OMIDRIA group had an 87% overall reduction in observed IFIS symptoms, 79% reduction in iris prolapse, and 90% reduction in severe billowing.

Investigator-initiated, double-masked study in 50 male patients (50 eyes). Dr Silverstein is a consultant for Omeros Corporation.

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Indications and Usage

OMIDRIA® 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 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.

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 2018, all rights reserved. 2018-061

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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. 2018;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 [published correction appears in J Cataract Refract Surg. 2016;42:349] 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. 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. Roach L. Strategies for preventing intraoperative miosis. EyeNet. June 2015:29-31.
  9. Chang DF, Campbell JR, Colin J, Schweitzer C; Study Surgeon Group. Prospective masked comparison of intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmology. 2014;121:829-834.
  10. 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. Ophthalmology. 2004;111:1693-1698.
  11. 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.
  12. Porela-Tiihonen S, Kaarniranta K, Kokki M. Postoperative pain after cataract surgery. J Cataract Refract Surg. 2013;39:789-798.
  13. Omeros data on file.
  14. Silverstein SM, Rana V, Stephens R, Segars L, Pankratz J, Shivani 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.
  15. 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.
  16. 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.
  17. Walter K, Delwadia N. Miosis prevention in femtosecond cataract surgery using a continuous infusion of phenylephrine and ketorolac. Presented at: 2018 American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting; April 13-17, 2018; Washington, DC.
  18. Matossian C. Clinical outcomes of phenylephrine/ketorolac vs. epinephrine in cataract surgery in a real-world setting. Presented at: American Society of Cataract and Refractive Surgery (ASCRS) and American Society of Ophthalmic Administrators (ASOA) Annual Meeting; April 13-17, 2018; Washington, DC.
  19. Gayton JL. E-poster presented at: 15th International Congress on Vision Science and Eye; 2017 Aug 10-11; London, UK.
  20. Waterbury LD. Alternative drug delivery for patients undergoing cataract surgery as demonstrated in a canine model. J Ocul Pharmacol Ther. 2018;34:154-160.
  21. Medicare program: Proposed changes to hospital outpatient prospective payment and ambulatory surgical center payment systems and quality reporting programs; requests for information on promoting interoperability and electronic health care information, price transparency, and leveraging authority for the competitive acquisition program for part B drugs and biologicals for a potential CMS innovation center model. Fed Regist. 2018;37046-37240.
  22. Kaiser Family Foundation analysis of the CMS Medicare Current Beneficiary Survey Cost and Use File, 2010.
  23. Guzek JP, Holm M, et al. Cotter JB, Cameron JA, Rademaker WJ, et al. Risk factors for intraoperative complications in 1000 extracapsular cataract cases. Ophthalmology. 1987;94(5):461-466.