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.
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.
The most common adverse reaction is mydriasis (approximately 25%).
For additional information about IHEEZO™, including important safety information, please see the Full Prescribing Information.
Harrow (Nasdaq: HROW) is a leading U.S. eyecare pharmaceutical company serving ophthalmologists and optometrists by providing FDA-approved branded ophthalmic pharmaceuticals and innovative compounded prescription medicines that are accessible and affordable. Harrow’s mission is to help eyecare professionals protect the gift of sight for their patients. For more information about Harrow, please visit the Investors section of the corporate website, harrow.com.
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include the continued impact of the COVID-19 pandemic and any future health epidemics on our financial condition, liquidity and results of operations; our ability to make commercially available our FDA-approved products and compounded formulations and technologies in a timely manner or at all; market acceptance of the Company’s products and challenges related to the marketing of the Company’s products; risks related to our pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our products; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and products; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's website at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.