Harrow Announces Closing of Acquisition of Melt Pharmaceuticals

NASHVILLE, Tenn., Nov. 18, 2025 – Harrow, Inc. (Nasdaq: HROW), a leading North American provider of ophthalmic disease‑management solutions, today announced that it has completed the acquisition of Melt Pharmaceuticals, Inc. (“Melt”), a clinical‑stage pharmaceutical company developing non‑opioid, non‑intravenous (non‑IV) sedation therapies for hospital, outpatient and in‑office procedural settings. The acquisition brings to Harrow Melt’s pipeline of product candidates—MELT‑210, MELT‑300 and MELT‑400—based on its proprietary Zydis® oral dissolving tablet (ODT) platform. Melt’s technology has global patent coverage and applies across a broad range of procedural sedation and anxiety management settings, including ophthalmology, gastroenterology, dental care and other outpatient use‑cases. A key asset is MELT‑300, a sublingual, fixed‑dose tablet combining midazolam (3 mg) and ketamine (50 mg), designed to provide rapid, predictable sedation without IV access. Phase 2 and Phase 3 programs reportedly demonstrated statistical superiority of MELT‑300 versus midazolam alone. Harrow plans to integrate Melt fully into its operations, initiate one non‑clinical animal study and three pharmacokinetic (PK) studies to finalize the data package, aiming to submit a New Drug Application (NDA) in H1 2027, with regulatory review in H1 2028, and commercial launch scheduled for H2 2028. Previously, Harrow’s subsidiary ImprimisRx markets MKO Melt®, a compounded sublingual sedation product, currently used in more than 800 U.S. ophthalmic institutions—providing a commercial foothold for MELT‑300’s eventual launch. Mark L. Baum, CEO of Harrow, remarked that the development of MELT‑300 “marks a defining milestone” — the company’s first internally supported product progressing from ideation toward commercialization. He emphasized the significance of expanding safe, accessible sedation options that reduce opioid exposure and remove the need for IV access. Chief Scientific Officer Amir Shojaei added that MELT‑210 remains an important follow‑on candidate, studied in Phase 2/3 trials, and expected to provide a second commercialization opportunity from the Melt portfolio. The acquisition aligns with Harrow’s strategy to grow beyond ophthalmology into broader procedural sedation markets. The closing follows satisfaction or waiver of all merger conditions and the initial cash consideration was approximately US $4.3 million, with additional contingent regulatory and commercial milestone payments still in place. Forward‑looking statements in the release note that actual results may differ materially due to risks and uncertainties, including regulatory delays, commercialization challenges, competition, financing, and market acceptance. #SlimScan #GrowthStocks #CANSLIM