Generic Name: ketorolac and phenylephrine injection
Date of Approval: May 30, 2014
Company: Omeros Corporation
Treatment for: Use During Cataract Surgery or Intraocular Lens Replacement
FDA Approves Omidria
What it is Omidria?
Omidria is a combination of the anti-inflammatory agent ketorolac, and the mydriatic (pupil-dilating) agent phenylephrine. It is used during ophthalmic procedures such as cataract surgery or intraocular lens replacement (ILR) to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative pain.
Ketorolac was first approved as an ophthalmic preparation as Acular, which is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis, and for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Phenylephrine has long been used in prescription ophthalmic preparations for surgical and diagnostic procedures requiring vasoconstriction and pupillary dilation. It is also used in over-the-counter formulations to reduce redness of the eye due to minor eye irritations.
How is it used?
Omidria is diluted prior to use with an ophthalmic irrigating solution. The solution is then used as needed for the surgical procedure.
Systemic overdosage of phenylephrine may cause a rise in blood pressure. It may also cause headache, anxiety, nausea, vomiting, and ventricular arrhythmias.
Omidria is not approved for use in children.
Omidria is contraindicated in patients with a known hypersensitivity to any of its ingredients. It should be used with caution in individuals who have previously exhibited sensitivities to NSAIDs.
Pregnancy Category C. It is not known whether Omidria can cause fetal harm when administered to a pregnant woman. It should only be used if clearly needed.
Caution should be exercised when Omidria is administered to women who are breastfeeding.
Omidria side effects
The most common side effects reported include eye irritation, posterior capsule opacification, increased intraocular pressure, and anterior chamber inflammation.
See also: Side effects (in more detail)
Active ingredients: phenylephrine hydrochloride and ketorolac tromethamine
Inactive ingredients: citric acid monohydrate; sodium citrate dihydrate; water for injection; may include sodium hydroxide and/or hydrochloric acid for pH adjustment.
Omidria is manufactured by Seattle-based biopharmaceutical company Omeros Corporation.