LEDGEWOOD, N.J.ImprimisRx, America’s #1 Ophthalmic Pharmacy™, today announced the availability of Fortisite™, which includes a patent-pending compounded combination of Tobramycin 1.5% and Vancomycin 5%.
Compounded topical antibiotic formulations may be appropriate to prescribe for patients with clinical needs that are unmet by FDA-approved drug products. Fortisite, which includes a compounded combination antibiotic formulation (Tobramycin 1.5% and Vancomycin 5%) in solution, is tested for both potency and sterility before it is dispensed, and uniquely, is stable at refrigerated temperatures (5°C) for up to 180 days.
Fortisite formulations are currently available for individual patients through the ImprimisRx 503A national mail order pharmacy. Once available through the ImprimisRx FDA-registered and FDA-inspected 503B outsourcing facility, which is expected in the first half of 2023, physicians will be able, for the first time, to stock a fortified or high-concentration compounded antibiotic in their offices for the immediate treatment of patients-in-need. In addition, consistent with its commitment to patient access, ImprimisRx will provide a robust Patient Access Program and a 100% replacement guarantee for any expired 503B Fortisite product, ensuring all U.S. eyecare professionals can continuously stock Fortisite formulations in their offices without the additional expense associated with expired product replacement.
Eyecare professionals interested in learning more about Fortisite are invited to visit the ImprimisRx Boutique (Booth #4416) at the American Academy of Ophthalmology (AAO) meeting, which will take place Friday, September 30, 2022, through Monday, October 3, 2022, at McCormick Place in Chicago, Illinois.
To order Fortisite online, go to ImprimisRx.com/fortified, or call ImprimisRx Customer Care at 844-446-6979. Same-day shipping is currently available Monday through Friday for patients if a complete prescription is received by 12pm PT (3pm ET).
ImprimisRx is the nation’s leading ophthalmology-focused compounded pharmaceuticals brand, serving thousands of ophthalmologists and optometrists in all 50 states, with over 25 proprietary compounded ophthalmic formulations. For more information about ImprimisRx, including product ordering instructions, please visit imprimisrx.com. ImprimisRx is a wholly owned subsidiary of Harrow (NASDAQ: HROW).
Forward-Looking Statements of Harrow
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 web site at www.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.
* ImprimisRx specializes in customizing medications to meet unique patient and practitioner needs. No compounded medication is reviewed by the FDA for safety or efficacy. ImprimisRx does not compound copies of commercially available products.