Harrow, Inc. (NASDAQ: HROW), a U.S.-based provider of ophthalmic disease management solutions, announced on Friday that it has agreed to acquire Melt Pharmaceuticals, Inc., a clinical-stage company developing non-opioid, non-IV sedation therapies for hospitals and outpatient care.
The company noted that this acquisition is viewed as another important step in the mission to deliver innovative, patient-focused ophthalmic disease management solutions that extend beyond the limitations of traditional care.
The terms of the agreement have not been disclosed, and the completion of this acquisition is contingent upon customary closing conditions.
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Melt’s leading product, MELT-300, is a patented sublingual tablet containing 3 mg of midazolam and 50 mg of ketamine. It is designed to provide fast and consistent sedation and pain relief without intravenous administration, potentially enhancing outpatient treatment and reducing opioid use.
“MELT-300 has the potential to redefine the standard of care for millions of patients by providing a convenient, non-opioid alternative for procedural sedation,” said Mark L. Baum, Chief Executive Officer of Harrow.
The LOUISE Phase 3 clinical trial, conducted under a Special Protocol Assessment with the U.S. FDA, supports the potential for regulatory approval. Harrow plans to submit a New Drug Application for MELT-300 to the FDA in 2027, aiming for a U.S. launch in 2028.
The therapy builds on over ten years of physician experience with the company’s MKO Melt sublingual sedation used in more than 500,000 cataract surgeries, positioning Harrow to enter the multi-billion-dollar U.S. procedural sedation market.
Upon FDA approval of MELT-300, Harrow intends to ensure customer access to an FDA-approved product and discontinue the MKO Melt.
Beyond eye care, MELT-300’s formulation has potential applications in colonoscopies, MRIs, dental, and gastroenterology procedures.
Harrow expects this launch to diversify its perioperative product offerings, decrease opioid dependence in over 4 million annual U.S. cataract surgeries.
Utilizing Catalent’s Zydis oral dissolving tablet technology, MELT-300 aims to improve patient comfort with a needle-free, non-opioid approach suitable for office and outpatient settings.
The product is patented across North America, Europe, Asia, Australia, and the Middle East, with Harrow seeking global partners for commercialization.
Price Action: HROW shares were trading higher by 1.84% to $47.00 premarket at last check Friday.
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