The Food and Drug Administration (FDA) has approved Iheezo™ (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia.
Iheezo, an ester anesthetic, is a sterile, preservative-free, single-patient‑use, ophthalmic gel preparation indicated for administration under the direct supervision of a health care provider. The product is applied topically to the ocular surface in the area of the planned procedure and may be reapplied as needed to maintain anesthetic effect.
The approval was based on data from 3 clinical studies. Study 1 (ClinicalTrials.gov Identifier: NCT04779606) and Study 2 (ClinicalTrials.gov Identifier: NCT04753710) were randomized, double-blind, placebo-controlled studies that evaluated the efficacy and safety of Iheezo in 145 healthy volunteers. In Study 1, patients were randomly assigned 4:1 to receive a single ocular instillation of Iheezo (n=68) or placebo (n=17). In Study 2, patients were randomly assigned 2:1 to receive single or multiple ocular instillations of Iheezo (3 drops in the right eye).
Results from Study 1 showed that 90% of patients administered Iheezo achieved successful anesthesia compared with 12% of patients who received placebo (P <.01). The median time to achieving anesthesia with Iheezo was 0.67 minutes. The median duration of anesthesia was 14.3 minutes.
In Study 2, 95% of patients administered Iheezo achieved successful anesthesia compared with 20% of patients who received placebo (P <.01). The median time to achieving anesthesia with Iheezo was 0.67 minutes. The median duration of anesthesia was 19.3 minutes.
Study 3 (ClinicalTrials.gov Identifier: NCT04685538) was a randomized, prospective, multicenter, active-controlled, observer-masked study that compared Iheezo (n=166) to tetracaine ophthalmic solution 0.5% (n=172) in patients undergoing cataract surgery. Findings showed that the Iheezo group achieved sufficient anesthesia in 1 to 1.5 minutes. None of the Iheezo-treated patients required supplemental treatment to complete the surgical procedure, which lasted on average 22 minutes.
The most common adverse reaction reported with Iheezo was mydriasis (approximately 25%).
Iheezo is supplied as a package of 1- or 10-units of 1.25mL single-patient-use vial(s) containing 24mg of chloroprocaine in 800mg of gel.
- Harrow announces US FDA approval of Iheezo™ (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. News release. Harrow and Sintetica, SA. Accessed September 27, 2022. https://www.businesswire.com/news/home/20220927005982/en/Harrow-Announces-U.S.-FDA-Approval-of-IHEEZO%E2%84%A2-Chloroprocaine-Hydrochloride-Ophthalmic-Gel-3-for-Ocular-Surface-Anesthesia
- Iheezo. Package Insert. Harrow; 2022. Accessed September 28, 2022.