Pilot Testing Iheezo, the First Topical Anesthetic Approved for Eye Care in 14 Years
By William F. Wiley, MD
We all encounter pain points in delivering eye care, from containing costs to maintaining patient satisfaction in a complex clinical environment.
As a study investigator and an early adopter of ocular medications and devices, I support innovations designed to alleviate those problems. For instance, I’m proud to have been among the first ophthalmologists in Northern Ohio to offer practice-changing techniques including laser-assisted cataract surgery and iStent for glaucoma.
Most recently, I jumped at the chance to ease pain points both literally and figuratively by pilot testing an ocular anesthetic. In the weeks leading up to its May 2023 launch at the Annual Meeting of the American Society of Cataract and Refractive Surgery (ASCRS), I administered Iheezo (chloroprocaine hydrochloride ophthalmic gel 3%) to a couple of dozen patients undergoing cataract or refractive surgeries.
Approved by the Food and Drug Administration on September 26, 2022, Iheezo intrigued me as the first new topical anesthetic introduced for ophthalmic use in the United States in 14 years. It’s also the first to have a reimbursement code assigned by the Centers for Medicare & Medicaid Services (CMS), reducing pressure on practitioners who previously had to categorize topical anesthesia as an overhead expense.
During the ASCRS meeting, I visited Harrow’s booth to discuss my early experiences with its novel anesthetic,1 which I appreciated for its preservative-free formulation, powerful pain control, and ability to thoroughly coat the eye, limiting desiccation that can interfere with diagnostics and surgery. Based on my observations, as well as on Phase 3 safety and efficacy findings also presented at the meeting,2 I’m convinced there will be a place for Iheezo across all ocular procedures where topical anesthetic is appropriate.
That’s a quickly growing need, as our toolbox is expanding: In the past decade and a half, we’ve come to rely on premium intraocular lenses, femtosecond lasers, biometry techniques, thermal pulsation for dry eye, all-laser LASIK surgery, and novel lid and gland procedures. In-office injections for the treatment of retinal conditions have also reshaped ophthalmology, becoming the most common ocular procedure.3,4
These advancements, along with their accompanying price tags, have shifted patient expectations. The individuals we treat still seek the best possible visual outcomes, but they also demand a pristine end-to-end surgical experience that prioritizes physical and emotional comfort.
Topical anesthesia options that are safe, effective, non-irritating, and easy to administer can help us provide that.
Choosing a Topical Anesthetic
In recent years, my primary candidates for topical pain control during cataract surgery have been proparacaine, tetracaine, and lidocaine. These drugs keep my patients comfortable but come with some drawbacks.
Preserved with benzalkonium chloride and chlorobutanol, respectively, proparacaine and tetracaine can cause epithelial toxicity. Furthermore, their thin solutions can wash away, leading to dryness that exacerbates toxicity, interrupts our surgical view, and interferes with interoperative aberrometry.
That chain of events can also delay visual recovery, dimming the next-day “wow factor” for patients.
Lidocaine offers advantages as a preservative-free gel that better coats the eye’s surface. Unfortunately, its clumpy texture provides patchy coverage, and it offers less powerful pain control than tetracaine.
How does Iheezo compare?
Chloroprocaine is tried and tested, having been used as a spinally administered anesthetic in the U.S. since 1952.5 In its ophthalmic formulation, the agent has demonstrated a 90-second onset with pain relief lasting an average 21.5 minutes, making it appropriate for use during routine eye procedures.
The Phase III randomized study, conducted in 184 patients across 26 sites, demonstrated Iheezo’s anesthetic equivalence to tetracaine 0.5% solution during cataract surgery. Tolerability and safety were superior in patients treated with Iheezo, whose most common side effect was mydriasis.
In administering Iheezo to my patients, I found that its gel formulation coated the eye more smoothly and uniformly than lidocaine’s. In addition, its single-use vials reduced clinic prep time while lowering the risk of contamination associated with multiuse bottles, such as those used to package proparacaine and tetracaine.
A notable finding from the study demonstrates Iheezo’s effectiveness as a monotherapy.
While surgeons may pair Iheezo with IV sedation as part of a traditional “belt-and-suspenders” strategy, they should be aware that it’s effective alone — particularly when assessing patient risk factors for opioid addiction.
Many of us care for older patients who are at risk of falling or developing joint problems. By administering fentanyl, we may inadvertently be priming these patients for addiction, which could arise with a second exposure to opioids — perhaps after a hip surgery.
To steer clear of those issues while still calming patients, I have had success pairing Iheezo with MKO Melt, a sublingual sedative that contains midazolam, ketamine, and odansetron. This combination has provided excellent patient comfort without IV needle sticks — more reliably than pairing MKO Melt with older topical anesthetics, which has sometimes been insufficient.
Based on these outcomes, I anticipate that coupling Iheezo and MKO Melt will eliminate the need for fentanyl sedation in nearly all my patients.
Clinicians may also appreciate Iheezo as the only FDA-approved, topical ocular anesthetic with routes for separate reimbursement in all traditional care settings.
The drug’s permanent CMS J-code — J-2403 — can help facilitate reimbursement for in-office care, and Iheezo is eligible for transitional pass-through reimbursement in both the ambulatory surgery center and hospital outpatient care settings.
These reimbursements will be helpful to surgeons who administer Iheezo during procedures, from cataract and glaucoma surgeries to treatments for corneal and retinal diseases.
As practitioners, we should be proud of our growing ability to improve outcomes by employing the latest surgical techniques. But we should also keep in mind that discomfort, if it arises, is what patients will remember the most about their procedures — perhaps making them less likely to pursue vision-saving care in the future.
Iheezo gives us a promising new avenue for preventing that pain, and I look forward to seeing the role it will play in accelerating the pace of ophthalmologic innovation.
William F. Wiley, MD, is a board-certified ophthalmologist who serves as medical director of the Cleveland Eye Clinic and an assistant clinical professor of ophthalmology at University Hospitals/Case Western University.
Disclosures: Dr. Wiley is a consultant for Harrow, Allergan, and Alcon.
- Harrow to Launch FDA-Approved IHEEZO™ at the 2023 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. Businesswire.com. May 4, 2023. Accessed May 23, 2023. https://tinyurl.com/yttch5v2
- Lindstrom RL. Prospective, Randomized Comparison of Chloroprocaine 3% Gel and Tetracaine 0.5% Solution for Cataract Surgery Anesthesia. Paper presented at: Annual Meeting of the American Society of Cataract and Refractive Surgery; May 5-8, 2023; San Diego, CA. https://ascrs.confex.com/ascrs/23am/meetingapp.cgi/Paper/89042
- Lam LA, Mehta S, Lad EM, et al. Intravitreal Injection Therapy: Current Techniques and Supplemental Services. J Vitreoretin Dis. 2021;5(5):438-447. doi: 10.1177/24741264211028441
- Mackin AG, Shaw LT, Skondra D, Hariprasad SM. Optimizing the Patient Experience for Intravitreal Injections. Retinal Physician. 2021;18:21-23. Accessed May 23, 2023. https://www.retinalphysician.com/issues/2021/july-august-2021/optimizing-the-patient-experience-for-intravitreal
- Siddaiah J, Pujari VS, Madalu AS, et al. A comparative study on the effect of addition of intrathecal buprenorphine to 2-chloroprocaine spinal anesthesia in short duration surgeries. J Anaesthesiol Clin Pharmacol. 2019;35(4):533-539. doi: 10.4103/joacp.JOACP_65_19