Important Safety Information
Full Prescribing Information
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About
OMIDRIA
When pupil diameter decreases, the operative field decreases exponentially¹
Miosis is unpredictable, even in patients who do not have risk factors that can lead to surgical complications.²˒³
MIOSIS CAN OCCUR AT ANY TIME DURING CATARACT SURGERY
REFERENCES:
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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.
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Chang DF, Campbell JR, Colin J, Schweitzer C; the Study Surgeon Group. Prospective masked comparison of intraoperative floppy iris syndrome severity with tamsulosin versus alfuzosin. Ophthalmol. 2014;121(4):829-834.
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Roach L. Strategies for preventing intraoperative miosis. EyeNet. June 2015:29-31.
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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(6):867-872.
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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.
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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(8):1032-1041.
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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.
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Akman 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.
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Porela-Tiihonen S, Kaarniranta K, Kokki H. Postoperative pain after cataract surgery. J Cataract Refract Surg. 2013;39:789-798.
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Osher RH, Ahmed IIK, Demopulos GA. OMS302 (phenylephrine and ketorolac injection) 1%/0.3% to maintain intraoperative pupil size and to prevent postoperative ocular pain in cataract surgery with intraocular lens replacement. Expert Rev Ophthalmol. 2015;10(2):91-103.
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Jiang L, Zhang K, He W, Zhu X, Zhou P, Lu Y. Perceived pain during cataract surgery with topical anesthesia: a comparison between first-eye and second-eye surgery. J Ophthalmol. 2015;383456:1-6.
Unplanned events can lead to a cascade of complications²˒⁴⁻⁹
Despite your best efforts, miosis during cataract surgery can result in⁷˒⁸˒¹⁰:
The need for pupil expansion devices
More frequent surgical complications
Increased surgical time
IFIS is unpredictable²
Progressive intraoperative miosis, iris prolapse, or iris billowing can occur without warning during any stage of cataract surgery
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 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.
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 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.
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.