Harrow Completes Transfer of the TRIESENCE New Drug Application
November 30, 2023 at 08:27 am EST
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NASHVILLE - Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL, a synthetic corticosteroid indicated for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids as well as visualization during vitrectomy.
In January of 2023, Harrow agreed to acquire the U.S. commercial rights to TRIESENCE. Aside from the transfer of the TRIESENCE NDA ahead of the date previously agreed to, all other acquisition terms remain unchanged.
'While we continue to diligently work with our contract manufacturing partner, making solid progress manufacturing commercial batches of TRIESENCE, the mutual agreement to an early transfer of the TRIESENCE NDA was an important step in advancing our strategy to re-launch the product under the Harrow umbrella,' said Mark L. Baum, Chief Executive Officer of Harrow. 'With this crucial process completed, our team has begun to implement our market access, marketing, inventory management, national sales detailing, and other brand-leveraging strategies so that we will be ready to re-launch TRIESENCE in the U.S. once we have achieved a successful inventory build, which we are currently working diligently towards. We remain excited to be able to provide TRIESENCE to the U.S. ophthalmic community soon.'
About Harrow
Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the U.S. market. Harrow helps U.S. eyecare professionals preserve the gift of sight by making its comprehensive portfolio of prescription and non-prescription pharmaceutical products accessible and affordable to millions of Americans each year.
Forward-Looking Statements
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, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks and uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. 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 web site 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.
Harrow, Inc. is an eyecare pharmaceutical company. The Company is engaged in the discovery, development, and commercialization of ophthalmic pharmaceutical products for the United States market. It provides a comprehensive portfolio of prescription and non-prescription pharmaceutical products. It owns commercial rights to portfolios of branded ophthalmic pharmaceutical products in North America, all of which are marketed under the Harrow name. It owns and operates ImprimisRx, an ophthalmology-focused pharmaceutical-compounding business. It owns United States commercial rights to various products: IHEEZO, VEVYE, TRIESENCE, VIGAMOX, ILEVRO, FLAREX, NATACYN, ZERVIATE and others. VIGAMOX (moxifloxacin hydrochloride ophthalmic solution) 0.5%, a fluoroquinolone antibiotic eye drops for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms. IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% is a low-viscosity gel indicated for ocular surface anesthesia.
HARROW, INC. 
