FDA Approves Chloroprocaine Hydrochloride Ophthalmic Gel for Ocular Surface Anesthesia
Iheezo is a sterile, single use ophthalmic gel preparation.
The FDA has approved chloroprocaine hydrochloride ophthalmic gel 3% (Iheezo; Harrow) for use as an ocular surface anesthesia. Iheezo is a sterile, single‑use ophthalmic gel preparation administered by physicians. The treatment contains no preservatives and is safe and effective for ocular surface anesthesia, according to a Harrow press release.
Iheezo is the first chloroprocaine hydrochloride approved for use in the US ophthalmic market and the first branded ocular anesthetic approved in nearly 14 years, according to Harrow.
“On behalf of all our ophthalmic physician partners and the patients they serve, we and our partners at Sintetica are grateful to the FDA for a New Drug Application review process that resulted in the approval of Iheezo in advance of our PDUFA target action date,” said Mark L. Baum, Harrow chairman and chief executive officer, in a press release. “We have always believed in the unique clinical value of Iheezo, and now that Iheezo is approved for use in the US market, it has the potential to become an indispensable premium tool for eyecare professionals and their patients requiring ocular surface anesthesia.”
Iheezo’s safety and efficacy were shown in 3 clinical trials, 2 of which were randomized, double-blinded, placebo-controlled studies analyzing the effect of the drug on healthy volunteers. The third was a randomized, prospective, multi-center, active-controlled, observer‑masked study analyzing use of Iheezo in patients undergoing cataract surgery. This study was the first time that a drug candidate was evaluated in the United States using a surgical model for FDA approval in the ocular surface anesthesia category.
The results showed that Iheezo worked quick in approximately 1 to 1.5 minutes and provided sufficient anesthesia to successfully perform the surgical procedure, which lasted an average of 22 minutes. Notably, no patient administered Iheezo needed supplemental treatment to complete the procedure, according to Harrow.
Iheezo is contraindicated in patients who have a history of hypersensitivity to any component of the medication. The drug should not be injected or administered intraocularly.
Patients should avoid touching the eye for up to 20 minutes following use of an anesthetic because accidental injuries may occur due to eye insensitivity. Prolonged use of a topical ocular anesthetic could lead to permanent corneal opacification and ulceration with accompanying visual loss, according to Harrow.
The most common adverse event reported with Iheezo is mydriasis, which occurred in approximately 25% of patients.
“I am particularly proud of this important milestone, which exemplifies the quality of Sintetica’s research and development groups and our ability to innovate—to be a global pharmaceuticals leader. I want to give special thanks to our regulatory group, who while working with the Harrow team, performed extraordinarily well, resulting in this early US market approval for this important new medicine,” said Nicola Caronzolo, Sintetica chief executive officer, in a press release.
Harrow Announces U.S. FDA Approval of IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia. Harrow. News release. September 27, 2022. https://www.businesswire.com/news/home/20220927005982/en