Harrow Announces U.S. FDA Approval of IHEEZO (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia - Seite 2

According to a September 2021 report by Market Scope, there are an estimated 4.5 million cataract surgeries and over 8 million intravitreal injections performed annually in the U.S., all of which typically utilize some form of ocular surface anesthesia.

Baum continued, “Harrow currently provides perioperative medications for a significant number of the U.S. ophthalmic surgical procedures. We believe our customer base of more than 10,000 ophthalmologists, optometrists, retina specialists, outpatient hospital facilities, and ambulatory surgery centers will appreciate the unique clinical value and practice efficiency IHEEZO offers, including its single‑use packaging format, which according to the Institute for Safe Medication Practices (ISMP), decreases the risk of infection and medication errors associated with the use of communal eye drops.

“We have been planning for the commercial launch of IHEEZO for over a year, and with our national market access and sales organization already in place, we are 100% ready. Given our earlier FDA approval date, we have accelerated our market access strategy to support a commercial launch date slightly ahead of our previously planned launch at the May 2023 American Society of Cataract and Refractive Surgery (ASCRS) meeting in San Diego, CA.”

About IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%

INDICATIONS AND USAGE

IHEEZO is indicated for ocular surface anesthesia.

CONTRAINDICATIONS

IHEEZO is contraindicated in patients with a history of hypersensitivity to any component of this preparation.

WARNINGS AND PRECAUTIONS

IHEEZO should not be injected or intraocularly administered. Patients should not touch the eye for at least 10 to 20 minutes after using an anesthetic as accidental injuries can occur due to insensitivity of the eye. Prolonged use of a topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. Do not touch the dropper tip to any surface as this may contaminate the gel. IHEEZO^TM is indicated for administration under the direct supervision of a healthcare provider. IHEEZO is not intended for patient self-administration.