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Harrow (Nasdaq: HROW), a prominent U.S. eyecare pharmaceutical company, has announced the launch of its patent-pending compounded Atropine formulations, now accessible via its subsidiary, ImprimisRx. These innovative formulations, priced from $39 per 5mL bottle, are preservative-free and have a physiologic pH of 5.5, with a storage life of up to 180 days at room temperature. CEO Mark L. Baum emphasized the commitment to providing accessible and affordable ophthalmic medications to address unresolved patient needs. However, compounded medications are not FDA-reviewed for safety or efficacy.
Positive
Launch of patent-pending compounded Atropine formulations.
Formulations priced at $39 per 5mL bottle, enhancing affordability.
Products do not contain preservatives or boric acid, appealing to consumer safety.
Negative
Compounded medications are not reviewed by the FDA, posing potential safety and efficacy concerns.
Formulations Do Not Contain Preservatives or Boric Acid, Have a Physiologic pH of 5.5, and May Be Stored at Room Temperature For Up to 180 Days
NASHVILLE, Tenn.--(BUSINESS WIRE)--
Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the launch of its patent-pending, next-generation compounded Atropine formulations, which are now available through Harrow’s wholly owned compounding and mail order pharmacy subsidiary, ImprimisRx.
In commenting on the announcement, Mark L. Baum, Chairman and Chief Executive Officer of Harrow, said, “Our mission has always been to help our eyecare professionals address their patients’ unmet needs and to make ophthalmic medications both accessible and affordable. The availability of these innovative compounded atropine formulations is in keeping with our mission. We believe ophthalmologists, optometrists, and the millions of Americans who may benefit from topical atropine therapy, will appreciate the tremendous value these patent-pending formulations offer.”
Key Attributes of the ImprimisRx Next-Generation Atropine Formulations:
Undergo validated analytical tests to ensure consistency, potency, and stability.
Do not contain either preservatives or boric acid.
Have a physiologic pH of 5.5.
May be stored at room temperature for up to 180 days.
Eyecare professionals can order these new compounded atropine formulations for as low as $39 per 5mL bottle – either online at atropine.com or by calling or texting 615‑437‑4690 to speak to ImprimisRx Customer Service.
Compounded formulations may be appropriate to prescribe for patients with clinical needs that are unmet by FDA-approved drug products. Compounded medications are not reviewed by the FDA for safety or efficacy. ImprimisRx does not compound copies of commercially available products.
Harrow (Nasdaq: HROW) is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten (10) FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, the leading U.S. ophthalmic‑focused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt.
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 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.
