NASHVILLE - Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) for the following products: FLAREX 0.1%, a corticosteroid indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
NATACYN (natamycin ophthalmic suspension) 5%, a sterile antifungal for treating fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis.
TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, an antibiotic and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults and holds orphan-drug exclusivity.
ZERVIATE (cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treating ocular itching associated with allergic conjunctivitis.
Harrow announced its acquisition of the U.S. commercial rights of these products in July of 2023. To date, Harrow has been receiving profit transfers on these products; however, with the transfer of the NDAs completed, Harrow has launched these products in the U.S. under the Harrow name.
In commenting on the announcement, Mark L. Baum, Chief Executive Officer of Harrow, said, 'With the completion of the NDA transfer process for the branded ophthalmic portfolio that we recently acquired, our marketing and sales teams are hard at work implementing commercial strategies aimed at increasing brand awareness and sales for these products. These products and others we acquired this year support a growing awareness among U.S. eyecare professionals that Harrow is exclusively focused on and committed to serving U.S. eyecare professionals with a full range of high-quality, accessible, and affordable products they need to care for their patients.'
Product orders for FLAREX, NATACYN, TOBRADEX ST, VERKAZIA, and ZERVIATE can be made directly through Harrow's dedicated customer service ordering partner, Cardinal's Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.
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 that 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.
Contact:
Jamie Webb
Email: jwebb@harrowinc.com
Tel: 615-733-4737
HARROW, INC. 
