Iheezo offers high level of absorption, less narcotic, and now permanent pass-through status.

“A comfortable eye throughout the procedure is crucial for cataract surgery and even more so in premium procedures when our patients’ expectations are so elevated,” says John Hovanesian, MD, who is in private practice at Harvard Eye Associates in Laguna Hills, Calif., and is a clinical instructor at Jules Stein Eye Institute, University of California, Los Angeles.

To achieve that level of comfort that is critical for successful cataract surgery, he utilizes Iheezo, chloroprocaine hydrochloride ophthalmic gel 3%, the first branded ocular anesthetic FDA approved for the US ophthalmic market in nearly 14 years. Licensed by Harrow from Sintetica, SA, a single dose of the preservative-free, low-viscosity gel was shown to provide enough ocular surface anesthesia to last for the duration of routine cataract surgery, an average of 21.5 minutes, according to Harrow.¹

Among Iheezo’s benefits are the fast onset — less than 90 seconds — long duration, and the need for only three drops to perform the entire case. With most other commonly used anesthetics such as lidocaine, tetracaine and proparacaine, surgeons often must repeat dosing throughout the case to keep the eye properly anesthetized. Exposing the corneal surface to multiple anesthetic drops can be detrimental to ocular health. When the potential to eliminate intracameral lidocaine from procedures when using Iheezo is factored in, its use can also streamline the procedure.

AVOID THE OPIOID

With Iheezo, supplemental anesthesia to complete the cataract procedure can often be avoided. In the Phase 3 trial and in some of the evaluations that have taken place, surgeons are reporting that they are not using IV opioids (fentanyl) to complete the cataract procedure.

“In my hands, Iheezo seems to work better than my routine lidocaine,” says Dr. Hovanesian. “In addition to its rapid metabolization, it may be that a high level of absorption into the tissues causes patients to feel less discomfort.”

This benefit, he continues, translates to less supplemental sedation needed during surgery as well as less narcotic medication.^1,2 An estimated 4% to 9% of adults 65 or older use prescription opioid medications for pain relief.³ The proportion of adults 55 and older seeking treatment for opioid use disorder increased nearly 54% from 2013 to 2015, while the overall population of that demographic increased only 6%.

“Although we commonly use fentanyl, any opportunity to avoid opioids is desirable. We know that a small but nevertheless important percentage of our patients struggle or have struggled with addiction, and exposure to opioids in the operating room can cause a relapse,” Dr. Hovanesian says.

STUDY DETAILS

In the Phase 3 clinical trial in patients undergoing routine cataract surgery, the average onset of anesthesia with Iheezo was less than 90 seconds and the average procedure lasted 10 to 15 minutes — a typical duration for many typical ophthalmic procedures, the company states.⁴ No patient treated with Iheezo required supplemental treatment to maintain anesthesia.¹

This formulation has an established safety profile comparable to other local anesthetics.¹ In the clinical trials, the most common adverse reactions following Iheezo administration were mydriasis (26%), conjunctival hyperemia (11%) and eye irritation (6%). Iheezo requires no change to surgical routine and is supplied in a time-saving single dose vial.¹

A prospective controlled study conducted at 26 sites randomized the first eyes of patients undergoing routine cataract surgery to receive three drops of chloroprocaine 3% gel (CG) (n = 167) or tetracaine 0.5% solution (TS) (n = 171) for anesthesia and pain management prior to surgery.⁵ The mean age of patients was approximately 70. Patients rated their pain levels just before the first incision (T1), after the capsulorhexis (T2), at the end of phacoemulsification (T3) and just before IOL insertion (T4). The primary outcome measure was the proportion of patients who rated their pain 0 (no pain/discomfort) or 1 (occasional pressure sensation) without any supplemental anesthetic/analgesic at T4. No opioids were given.

At T4, the proportion of patients with successful anesthesia was higher in the CG group (92.1%) than in the TS group (90.5%), a difference of 1.6% (CI 95%: [-3.5%;6.7%]) in the per-protocol data set, indicating equivalency, and 2.7% in the full analysis data set (CI 95%: [-2.6%;8.0%]), favoring CG. Mean duration in the CG group was 21.5 minutes. Zero patients treated with CG required supplemental treatment, according to the researchers. Treatment-emergent adverse events and increases in IOP and blood pressure were higher in the TS group.

The researchers concluded that chloroprocaine 3% gel was equivalent to tetracaine 0.5% solution in achieving anesthesia and managing intraoperative discomfort during routine cataract surgery, without the need for opioid sedation, and with superior tolerability and safety.

FACILITATED WITH A J-CODE

With a permanent, product-specific J-code, this novel drug is eligible for separate reimbursement indefinitely, so there is no cost to the surgery center for using Iheezo. Indicated for any type of procedure that requires ocular surface anesthesia, the gel is reimbursed for office use as well.

“From an accreditation standpoint, a single-patient use topical anesthetic drop that provides surgical anesthesia is a superior choice,” says Maggie Jeffries, MD, anesthesiologist, owner of Avanti Anesthesia, vice-president, Texas Ambulatory Surgery Center Society Board of Directors, and president, Ophthalmic Anesthesia Society. “The three-drop dosing provides adequate anesthesia throughout the patient experience and can also be used for the femtosecond laser treatment.”

“Sometimes clinicians can be hesitant to try new products, especially when they add cost or complexity,” Dr. Hovanesian adds. In this case, the J-code eliminates the cost barrier and Harrow’s reimbursement support team is available to facilitate reimbursement and answer surgeons’ coding and billing questions. “If we want innovation, then we need to encourage companies to innovate.” OM.

REFERENCES

1. Data on file. Harrow IP, LLC 2023.
2. Davidson RS, Donaldson K, Jeffries M. Persistent opioid use in cataract surgery pain management and the role of nonopioid alternatives. J Cataract Refract Surg. 2022;48:730-740.
3. Lehmann S, Fingerhood M. Substance-use disorders in later life. N Engl J Med. 2018;379: 2351-2360.
4. IHEEZO. Prescribing Information. Harrow IP, LLC; 2022.
5. Lindstrom RL. Prospective, randomized comparison of chloroprocaine 3% gel and tetracaine 0.5% solution for cataract surgery anesthesia. Presented at ASCRS; May 7, 2023; San Diego.