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     121  0 Kommentare Harrow Announces Permanent, Product-Specific J-Code (J2403) for IHEEZO (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia Effective April 1, 2023

    Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a permanent, product-specific J-code for IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. Under the Healthcare Common Procedure Coding System (HCPCS), the IHEEZO J‑code (J2403) will become effective April 1, 2023.

    In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “We are committed to the accessibility of new therapies that benefit eyecare professionals and the patients they serve. As we prepare for the commercial launch of IHEEZO in the coming months, we are grateful that IHEEZO will have its own permanent, product-specific J-code beginning April 1, 2023, enabling a more efficient billing process for ophthalmologists, optometrists, and retina specialists, and creating greater accessibility to the many clinical benefits that IHEEZO provides. We want to thank CMS for its consideration and timely review of our J-code application.”

    About IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%

    • 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 was approved by the FDA on September 26, 2022.
    • Clinical trials of IHEEZO demonstrated that patients treated with IHEEZO did not require any supplemental treatment to complete the intended surgical procedure.
    • 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.

    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 is indicated for administration under the direct supervision of a healthcare provider. IHEEZO is not intended for patient self-administration.

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    Harrow Announces Permanent, Product-Specific J-Code (J2403) for IHEEZO (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia Effective April 1, 2023 Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced that the Centers for Medicare & Medicaid Services (CMS) has issued a permanent, product-specific J-code for IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% …