Harrow Announces U.S. FDA Approval of IHEEZO™ (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia
NASHVILLE, Tenn. and MENDRISIO, Switzerland, September 28, 2022 /PRNewswire/ -- Harrow (Nasdaq: HROW), an eyecare pharmaceutical company exclusively focused on the discovery, development, and commercialization of innovative ophthalmic therapies, and Sintetica, S.A., a growing pharmaceutical company focused on analgesics, local anesthetics, and sterile injectable solutions, today jointly announced the U.S. Food and Drug Administration (FDA) approval of IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. IHEEZO is a sterile, single-patient-use, physician-administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia. IHEEZO 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. IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.
- IHEEZORepresentstheFirstApproved UseintheU.S.OphthalmicMarket of Chloroprocaine Hydrochloride and the First Branded Ocular Anesthetic Approved for the U.S. Ophthalmic Market in Nearly 14 Years
IHEEZO was Licensed by Harrow for the U.S. and Canadian Markets From100-Year-OldInternationalPharmaceuticalCompanySintetica,S.A. - IHEEZO represents the first approved use in the U.S. ophthalmicmarketof chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U.S. ophthalmic market in nearly 14 years.
- IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.
- Iwanttogivespecial thankstoourregulatorygroup, who while working with the Harrow team, performed extraordinarily well, resulting in this early U.S. market approval for this important new medicine."