This article is more than 5 years old. Information may no longer be current.
Combination injection during IOL replacement maintains mydriasis, reduces postop pain
Omidria received FDA approval in May and is now CMS reimbursable.
Click Here to Manage Email Alerts
A combination of phenylephrine and ketorolac tromethamine injected intracamerally during IOL replacement surgery with phacoemulsification maintained intraoperative pupil diameter and reduced postoperative pain, according to a study.
The bisulfite- and preservative-free Omidria (Omeros) is added to the irrigation solution used during cataract surgery.
“Phenylephrine dilates the pupil, whereas ketorolac prevents prostaglandin-induced miosis and reduces postop pain,” J. Steven Whitaker, MD, chief medical officer at Omeros, said. Whitaker served as medical monitor for the randomized, double-masked, placebo-controlled, multicenter phase 3 study that appeared in Clinical Ophthalmology.
Study methods
Of the 406 study eyes, 202 were randomized to the study drug group and 204 to the placebo group. The study drug group received 4 mL of Omidria added to 500 mL of standard balanced saline irrigation solution. Subjects in both groups received standard-of-care preoperative topical mydriatic and anesthetic agents, Whitaker told Ocular Surgery News.
The study drug provided significantly improved maintenance of mydriasis and prevention of miosis.
“Notably, both phenylephrine and ketorolac contributed to these effects,” Whitaker said.
In contrast, the placebo-treated group demonstrated progressive pupil constriction during the procedure.
“More than 25% of placebo-treated patients experienced intraoperative pupil constriction of 2.5 mm or more compared with 1% of Omidria-treated patients,” Whitaker said. “This degree of miosis in the placebo group represented more than a 50% reduction in the surgical field.”
Similarly, 23% of placebo-treated patients experienced a pupil diameter of less than 6 mm at the time of cortical clean-up vs. 4% of patients in the Omidria group.
“The literature demonstrates that the rate of operative complications increases by multiples when the pupil diameter is less than 6 mm,” Whitaker said.
The study drug also achieved a clinically meaningful reduction in postoperative ocular pain.
“Mean pain scores assessed using a visual analogue scale (VAS) in the placebo-treated group were more than double those in the Omidria-treated group,” Whitaker said.
Moderate to severe early postoperative pain (VAS of 40 or more at any time point) was reported twice as frequently by placebo-treated subjects (14%). Additionally, patients treated with Omidria reported being pain-free (VAS of 0) in the early postop period roughly 50% more frequently than did placebo-treated patients (26% vs. 17%, respectively).
Unexpected results
Whitaker said three of the study results were unexpected.
“First, significant miosis (pupil diameter less than 6 mm) was very common in placebo-treated patients, even though they received standard-of-care preoperative mydriatics,” he said. “Second, ketorolac demonstrated significant prevention of miosis, even when co-administered with phenylephrine, a potent alpha-adrenergic agonist. Finally, the relatively high number of placebo-treated subjects reporting moderate to severe pain in the early postop period was surprising.”
Overall, the combination of the two pharmacologically complementary agents offers “dual benefits on pupil diameter (maintenance of mydriasis and prevention of miosis) and postoperative analgesia,” Whitaker said.
Adverse events were comparable between the two groups. The most commonly reported ocular adverse reactions were eye irritation, posterior capsule opacification, increased IOP and anterior chamber inflammation.
Omidria was approved by the U.S. Food and Drug Administration for use during IOL replacement surgery in May 2014. As of Jan. 1, the product was scheduled to become reimbursable through the Centers for Medicare and Medicaid Services.
“Our company was very pleased to receive pass-through reimbursement status from CMS,” Whitaker said. “While we do not provide sales projections for Omidria, the response from the community of ophthalmic surgeons has been strongly positive.” – by Bob Kronemyer