Novel intracameral combination agent maintains intraoperative mydriasis, avoids miosis, and reduces postoperative pain

In cataract surgery, better exposure means easier, safer, faster surgery, but visualization is often hampered when a pupil constricts during surgery. For example, when the diameter of an 8.3-mm pupil decreases by 2.5 mm, 50% of the operative field is lost, and when pupils constrict to less than 6 mm, which happens in 50% of untreated eyes, surgery becomes problematic.¹

Traditionally, surgeons have various options, both pharmacologic and mechanical, for maintaining mydriasis and avoiding miosis during cataract surgery, but none have been standardized, and each comes with potential drawbacks.

Downsides of Traditional Options

Dilating drops and nonsteroidal anti-inflammatory drugs (NSAIDs) administered topically are washed out of the eye almost immediately during surgery. Intracameral mydriatic agents, which are not approved by FDA, must be compounded by local pharmacies or surgery staff — a practice associated with variations in drug potency and quality.¹

For cases in which pharmacologic dilation is insufficient, pupil-expanding devices, such as iris hooks and pupillary rings, are available; however, their use complicates and prolongs the procedure, traumatizes the iris, and permanently distorts the pupil. In addition, these devices are expensive, some costing upwards of $150.

An agent combining phenylephrine 1.0% and ketorolac 0.3% (Omidria, Omeros) overcomes these drawbacks and also reduces postoperative pain.

Trials Prove Efficacy

Omidria is indicated for use during cataract surgery or intraocular lens replacement to maintain pupil size and reduce postoperative ocular pain.² It is the only FDA-approved product that is added to the irrigation solution and infused continuously to maintain dilation during cataract surgery, thus avoiding washout.

In pivotal phase 3 trials in which all patients received standard pupil-dilating and anesthetic agents preoperatively, Omidria demonstrated statistically significant and clinically meaningful improvement in preventing miosis and reducing postoperative pain versus placebo.¹

Compared with off-label epinephrine, which is the most commonly used mydriatic agent, Omidria is markedly more effective. About 25% of eyes treated with epinephrine constricted to less than 6 mm versus only 6% in the Omidria group. Maintaining the pupil larger than 6 mm, as was the case in 94% of eyes with Omidria as opposed to 50% without Omidria, results in easier, faster surgery.

Clinical Advantages

In a review of cataract procedures, Bucci and Fluet found that about 8% of eyes that received intracameral epinephrine required a pupil-expanding device compared with about 3% of eyes receiving Omidria, which is a highly statistically significant result.³

In my OR, time is everything. We estimate it costs about $45 per minute to operate our OR. If we can avoid adding 2 to 4 minutes to a procedure plus the cost of a ring by using a product that takes no time, goes in the infusion bottle, comes at a reimbursed cost and works seamlessly, that is a big positive.

In another study, Rosenberg and colleagues evaluated a series of patients and found that surgical complication rates were about 1% in those who had Omidria versus about 4.5% in those who had epinephrine.⁴

Complications trigger a series of events that affect not only the patient, but also the surgeon and the facility. A ruptured posterior capsule, for example, will require a vitrectomy, which adds time to a procedure, as well as the cost of a vitrectomy pack. What’s more, this unplanned surgery must be reported and tracked, but cannot be billed. If we can use a product that helps us avoid complications, I believe that product should be our standard of care.

An Underappreciated Complication

Patients know that cataract surgery is safe, and they’re not expecting pain. They may have perfect visual acuity after their surgery, but if they experience pain, the surgeon has created a complication.

Pain does matter. This is surgery, after all, and the eye is an incredibly highly innervated part of the body. Eye pain is a major cause of disruption and is quite disconcerting to patients.

Omidria reduces postoperative pain for 10 to 12 hours after surgery. In the FDA trials, 14% of patients in the control group reported moderate to severe pain at any time point up to 12 hours after surgery compared with 7.1% of patients who received Omidria. Viewed from a different perspective, 17% of those in the control group were pain free compared with 26% of patients treated with Omidria.

As surgeons, we are not in the cataract business; we are in the people business, and we are here to serve our patients. To them, a successful surgery also includes minimal pain.

Boost Efficiency and Patient Satisfaction

A dilator combined with an inhibitor of pupil constriction that can be infused continuously throughout a case, Omidria provides benefits to patients by minimizing postoperative pain and inflammation, to surgeons by maintaining exposure of the operative field for a faster, easier surgery, and to surgery centers by improving efficiency and patients’ satisfaction.

They say the peak of technology is when it becomes invisible, and Omidria works invisibly in the infusion bottle. Simply put, it makes surgery smoother for all involved. ■

References

1. 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.
2. Omidria [package insert]. Seattle, WA: Omeros Corporation; 2016.
3. Bucci F, Fluet F. A comparison of the frequency of use of the Malyugin Ring with and without intracameral phenylephrine and ketorolac 1%/0.3%(phenyl/keto) injection at the time of routine cataract surgery. Paper presented at: Annual meeting of Association for Research in Vision and Ophthalmology; May 1, 2016; Seattle.
4. Rosenberg E, Nattis A, Alevi D, Donnenfeld E. Initial experience, visual outcomes, and efficacy of intracameral phenylephrine and ketorolac (1.0%/0.3%) during cataract surgery. Paper presented at: ASCRS/ASOA Symposium & Congress; May 9, 2016; New Orleans.