Harrow’s Iheezo, a topical ocular anesthetic, is the first FDA-approved use of chloroprocaine hydrochloride in the US ophthalmic market. The medication is also the first branded ocular anesthetic approved for the US ophthalmic market in nearly 14 years. Iheezo, a sterile, single-patient-use, physician-administered, ophthalmic gel preparation, doesn’t contain any preservatives. Harrow licensed Iheezo from Sintetica.

Omar Shakir, MD, MBA, CEO of Coastal Eye and Coastal Eye Surgery Center, both in Greenwich, Connecticut, who uses Iheezo at his practice, says the drug has a high viscosity that allows for effective numbing of the eye’s surface. Iheezo’s numbing effects last an average of 22 minutes, which is longer than other options. 

“If a procedure ends up lasting longer than planned, patients who were given Iheezo don’t require supplemental anesthesia or have to grin and bear the pain,” Dr. Shakir says. 

Having a preservative-free formulation helps to offset the risk in patients with an allergy or sensitivity, Dr. Shakir says. He adds that Iheezo is offered in single-use vials, which eliminates risk of cross contamination.

Clinical Applications

Dr. Shakir says Iheezo has a broad spectrum of uses for cataract, retina, and glaucoma surgeries. In the clinic, it can be used to numb patients’ eyes for laser procedures, individual injections, and other minor procedures. He has found Iheezo to be an ideal anesthetic to use when inserting Durysta, a long-lasting dissolvable implant to lower eye pressure in glaucoma patients. He also envisions Iheezo being used for other implant surgeries on the horizon for macular degeneration (both wet and dry), diabetic macular retinopathy, and macular edema. 

Typically, Iheezo is given in the preoperative area as a single drop put directly into the eye. The vial stays with the patient and enters the operating room, where additional drops are given, Dr. Shakir says. Usually, 3 drops are administered a few minutes apart. Iheezo should not be injected or intraocularly administered.

Iheezo’s ability to consistently be used to complete an ophthalmic procedure without supplemental treatment reduces exposure to other costly and potentially complicating interventions, such as subconjunctival injections, retrobulbar injections, and peribulbar injections, says John Saharek, chief commercial officer at Harrow in Nashville, Tennessee.

Another benefit of Iheezo is that in the phase 3 clinical trial, no patient received opioids to complete the procedure. “Procedures conducted in the clinic setting would benefit from a nonopioid solution,” Saharek says.¹

Iheezo, which has been issued a J-code (J2403) and transitional pass-through reimbursement status by the Centers for Medicare and Medicaid Services, allows for separate reimbursement from payers.

What Clinical Studies Showed

Iheezo is the only topical anesthetic studied against an active comparator in a well-controlled multisite, prospective, and randomized fashion, Saharek says. Iheezo’s safety and efficacy were demonstrated in 3 human clinical studies. Studies 1 and 2 were randomized, double-blinded, placebo-controlled studies that evaluated Iheezo’s effect on healthy volunteers, and study 3 was a randomized, prospective, multicenter, active-controlled, observer-masked study that evaluated the administration of Iheezo in patients undergoing cataract surgery.¹ 

Study 3 marked the first time a US drug candidate was studied in a surgical model for FDA approval in the ocular surface anesthesia category. This study demonstrated that Iheezo worked rapidly (in about 1 to 1.5 minutes) and provided sufficient anesthesia to successfully perform a surgical procedure. 

The most common adverse reactions in studies following Iheezo administration (incidence greater than or equal to 5%) were mydriasis, conjunctival hyperemia, and eye irritation. RP

References

1. IHEEZO. Prescribing information. Harrow Eye IP, LLC; 2022.