NASHVILLE, Tenn. & MENDRISIO, Switzerland–( )–Harrow (Nasdaq: HROW), an eyecare pharmaceutical company exclusively focused on the discovery, development, and commercialization associated with innovative ophthalmic therapies, plus Sintetica, S. A., a growing pharmaceutic company focused on analgesics, local anesthetics, and sterile injectable solutions, today jointly announced the U. S. Food and Drug Administration (FDA) approval of IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia. IHEEZO is the sterile, single-patient‑use, physician‑administered, ophthalmic gel preparation, containing no preservatives, that is safe and effective for ocular surface anesthesia. IHEEZO represents the first approved use in the U. H. ophthalmic market of chloroprocaine hydrochloride and the first branded ocular anesthetic approved for the U. T. ophthalmic marketplace in nearly 14 years. IHEEZO is protected by an Orange Book-listed patent that is valid until 2038.

On behalf of all our ophthalmic physician partners plus the patients they serve, we and our partners at Sintetica are grateful to the particular FDA with regard to a New Drug Application (NDA) review process that resulted in the authorization of IHEEZO in advance of our own PDUFA target action date, ” said Mark L. Baum, Harrow Chairman plus Chief Executive Officer. “ We have always believed in the unique clinical value associated with IHEEZO, and now that will IHEEZO will be approved regarding use inside the Circumstance. S. market, it has the potential to become an indispensable premium tool for eyecare professionals plus their individuals requiring ocular surface ease. ”

Nicola Caronzolo, Sintetica Ceo, added, “ I am particularly proud of this important milestone, which exemplifies the quality of Sintetica’s research and development groups and the ability to innovate – to be a global pharmaceuticals leader. I want in order to give special thanks to our regulatory group, who while working with the particular Harrow team, performed extraordinarily well, resulting in this particular early U. S. marketplace approval for this important new medicine. ”

The safety and efficacy of IHEEZO were demonstrated in three human medical studies. Studies 1 and 2 were randomized, double-blinded, placebo-controlled studies that evaluated the effect of IHEEZO on healthy volunteers, plus Study 3 was a randomized, prospective, multi-center, active-controlled, observer‑masked study that evaluated the administration of IHEEZO in patients undergoing cataract surgery. Study 3 marks the particular first time a U. S. drug candidate was studied within a surgical model intended for FDA acceptance in the ocular surface area anesthesia category. This study demonstrated that will IHEEZO not only worked rapidly (about 1 to 1. 5 minutes) and provided sufficient anesthesia to successfully perform the particular surgical procedure (on average lasting 22 minutes), but importantly, simply no patient dosed with IHEEZO required the supplemental treatment to complete the surgical procedure.

According to a September 2021 report simply by Market Scope , there are an estimated 4. 5 million cataract surgeries and over 8 million intravitreal injections performed annually in the Oughout. S., all of which typically utilize some form of ocular surface ease.

Baum continued, “ Harrow currently provides perioperative medications for a significant number of the You. S. ophthalmic surgical procedures. We believe our customer base associated with more than 10, 000 ophthalmologists, optometrists, retina specialists, outpatient hospital facilities, plus ambulatory surgical treatment centers will appreciate the unique clinical value and practice efficiency IHEEZO offers, including its single‑use packaging format, which according to the particular Institute to get Safe Medication Practices (ISMP), decreases the risk of infection and medication errors associated with the make use of communal eye drops.

We have been planning for the commercial launch associated with IHEEZO for over a year, and with our own national market access plus sales organization already in place, we are 100% ready. Given the earlier FOOD AND DRUG ADMINISTRATION approval date, we possess accelerated our market access strategy to support a commercial launch day slightly ahead of our own previously planned launch at the May 2023 American Society of Cataract and Refractive Surgery (ASCRS) meeting inside San Diego, CA. ”

About IHEEZO™ (chloroprocaine hydrochloride ophthalmic gel) 3%

INDICATIONS AND USAGE

IHEEZO™ is usually indicated pertaining to ocular surface anesthesia.

CONTRAINDICATIONS

IHEEZO™ is definitely contraindicated in patients with a history of hypersensitivity to any component of this preparation.

WARNINGS PLUS 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 particular eye. Prolonged use of the topical ocular anesthetic may produce permanent corneal opacification and ulceration with accompanying visual loss. Do not touch the dropper tip in order to any surface area as this particular may contaminate the gel. IHEEZO TM is indicated meant for administration under the direct supervision of a healthcare provider. IHEEZO™ can be not intended for patient self-administration.

ADVERSE REACTIONS

The most common adverse reaction is mydriasis (approximately 25%).

For additional information about IHEEZO™, including important safety information, please see the Full Prescribing Information.

About Harrow

Harrow (Nasdaq: HROW) is an eyecare pharmaceutical company specifically focused upon the finding, development, and commercialization of innovative ophthalmic therapies that are accessible and affordable. For more information about Harrow, which includes investment-related materials, please visit the corporate website, harrowinc. com , or even Harrow’s LinkedIn page.

About Sintetica

Based in Mendrisio, Switzerland, Sintetica is a growing privately held international pharmaceutical company focused on emergency plus intensive care, analgesics, local anesthetics and sterile injectable solutions within ampoules, vials and IV bags designed for hospitals. Sintetica develops medicines in concentrated, premixed plus ready-to-use formulations, which enables healthcare practitioners to administer these products without manipulation and dilution, increasing patient security and improving convenience just for patients plus HCPs. Sintetica runs sales subsidiaries in selected European markets and partners along with leading distributors around the world.

Harrow Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the U. S i9000. Private Securities Litigation Reform Act associated with 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 plus uncertainties which may cause results in order to differ materially and adversely from the claims contained herein. Some of the potential risks and uncertainties that could trigger actual results to differ from those predicted include the carried on impact of the COVID-19 pandemic plus any future health epidemics on our financial condition, liquidity and results of operations; our ability to make commercially available our FDA-approved products plus compounded products and technologies in a timely manner or at all; marketplace acceptance associated with the Company’s products and challenges related to the particular marketing from the Company’s products; risks related to our pharmacy operations; the ability to enter into other strategic alliances, including arrangements with pharmacies, physicians plus healthcare organizations for that development and distribution of our items; our capability to obtain intellectual property protection for our assets; our ability in order to accurately estimate our expenses and cash burn, and raise extra funds when necessary; risks associated with research and advancement activities; the projected size of the possible market for the purpose of our systems and products; unexpected brand new data, protection and technical issues; regulatory and market developments impacting compounding medical stores, outsourcing facilities and the particular pharmaceutical industry; competition; plus market conditions. These and additional dangers and uncertainties are a lot more fully described in Harrow’s filings with the Investments and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents might be read free of charge on the SEC’s web site at www.sec.gov . Undue reliance must not be placed about 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 time they may be made, or to reflect the occurrence of unanticipated events.

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