General Information

Omidria (phenylephrine and ketorolac injection) is a combination of an anti-inflammatory agent and a mydriatic agent (causes pupil dilation, called mydriasis).

Omidria is specifically indicated for use during cataract surgery or intraocular lens replacement for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain.

Mechanism of Action

Omidria contains the active ingredients phenylephrine and ketorolac. Phenylephrine is an a1-adrenergic receptor agonist and, in the eye, acts as a mydriatic agent by contracting the radial muscle of the iris. Ketorolac is a nonsteroidal anti-inflammatory that inhibits both cyclooxygenase enzymes (COX-1 and COX-2), resulting in a decrease in tissue concentrations of prostaglandins to reduce pain due to surgical trauma. Ketorolac, by inhibiting prostaglandin synthesis secondary to ocular surgical insult or direct mechanical stimulation of the iris, also prevents surgically induced miosis.

Side Effects

Adverse effects associated with the use of Omidria may include, but are not limited to, the following:

• Eye irritation
• Posterior capsule opacification
• Increased intraocular pressure
• Anterior chamber inflammation

Dosing/Administration

Omidria is supplied as a solution for intraocular administration. For administration, 4 mL of Omidria is diluted in 500 mL of ophthalmic irrigation solution. Irrigation solution is to be used as needed for the surgical procedure.

Clinical Trial Results

FDA Approval

The FDA approval of Omidria was based on three phase 3 randomized, multicenter, double-masked, placebo-controlled clinical trials in 808 adult subjects undergoing cataract surgery or intraocular lens replacement. Subjects were randomized to either Omidria or placebo. Subjects were treated with preoperative topical mydriatic and anesthetic agents. Pupil diameter was measured throughout the surgical procedure. Postoperative pain was evaluated by self-administered 0-100 mm visual analog scales (VAS). Mydriasis was maintained in the Omidria-treated groups while the placebo-treated groups experienced progressive constriction. At the end of cortical clean-up, 23 percent of placebo-treated subjects and 4 percent of Omidria-treated subjects had a pupil diameter less than 6 mm (p < 0.01). Pain during the initial 10 to 12 hours postoperatively was statistically significantly less in the Omidria-treated groups than in the placebo-treated groups. During the 10 to 12 hours postoperatively, 26 percent of Omidria-treated subjects reported no pain (VAS = 0 at all timepoints) while 17 percent of placebo-treated subjects reported no pain (p < 0.01).