ASCRS 2023: Harrow to launch FDA-approved chloroprocaine hydrochloride ophthalmic gel for ocular surface anesthesia

Harrow today announced the launch of FDA-approved IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia at the 2023 American Society of Cataract and Refractive Surgery (ASCRS) annual meeting being held May 5‑8, 2023, in San Diego, California.

According to the company, IHEEZO is a sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia. It was approved by the FDA on September 26, 2022.

Moreover, the clinical trials of the ophthalmic gel showed that patients treated with IHEEZO did not require any supplemental treatment to complete the intended surgical procedure. The company also noted in its news release that the gel represents the first approved use in the U.S. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years. It also is protected by an Orange Book-listed patent that is valid until 2038.

The company noted that IHEEZO is indicated for ocular surface anesthesia. It is contraindicated in patients with a history of hypersensitivity to any component of this preparation.

IHEEZO has been issued a J‑Code (J2403) and transitional pass-through reimbursement status by the Centers for Medicare & Medicaid Services (CMS).

Launch events

• Richard L. Lindstrom, MD, will be making a presentation titled, Prospective, Randomized Comparison of Chloroprocaine 3% Gel and Tetracaine 0.5% Solution for Cataract Surgery Anesthesia. The presentation is scheduled during the Medications (Preoperative, Postoperative, Intraoperative) session on Sunday, May 7, beginning at 3:40 p.m. PT in the SDCC, Upper Level, Room 5A.
• William Wiley, MD, will speak about his experience using IHEEZO during a booth talk scheduled to begin at 1:30 p.m. PT at Harrow’s booth #2237 on Saturday, May 6.
• Harrow will host the “Harrow Brings Nashville to San Diego” IHEEZO Launch Event at the Hard Rock Hotel in downtown San Diego from 5:30-7:30 p.m. on Saturday, May 6.