NASHVILLE, Tenn. — November 18, 2025 — Leads & Copy — Harrow (Nasdaq: HROW) has finalized its acquisition of Melt Pharmaceuticals, Inc., a pharmaceutical company focused on non-opioid, non-IV sedation therapies.
The acquisition brings Melt’s product candidates, including MELT-210, MELT-300, and MELT-400, into Harrow’s portfolio. These candidates utilize the Zydis® ODT drug delivery platform and aim to provide sedation for medical procedures in hospitals, outpatient facilities, and in-office settings.
Melt’s drug candidates have global patent coverage and applications beyond ophthalmology, including gastroenterology, dental care, and various outpatient procedures requiring sedation or anxiety management.
MELT-300, a sublingually delivered formulation of midazolam (3mg) and ketamine (50mg), is designed to provide rapid sedation without intravenous administration. Clinical trials have demonstrated its superiority to midazolam alone.
Harrow’s CEO, Mark L. Baum, noted that MELT-300 represents Harrow’s first product taken from concept to near commercialization. He emphasized the company’s excitement about MELT-300’s potential to transform procedural sedation, reduce opioid use, and expand safe sedation options.
Harrow’s Chief Scientific Officer, Amir Shojaei, highlighted the MELT-210 drug candidate, a sublingual dosage of midazolam (3mg), also part of the acquisition. Shojaei believes MELT-210 has strong commercial potential due to its rapid uptake and short half-life.
Dr. Lawrence Woodard, Medical Director of Omni Eye Services of Atlanta, expressed his reliance on MKO Melt® and the importance of MELT-300 in reducing opioid exposure and expanding access to safe sedation.
The MELT-300 program has completed Phase 3 clinical trials and is preparing for FDA approval and commercialization. Next steps include initiating supporting studies, submitting an NDA in H1 2027, and aiming for regulatory approval in H1 2028, with a potential commercial launch in H2 2028.
Melt Pharmaceuticals will be integrated into Harrow’s operations. Harrow will leverage its existing commercial infrastructure to drive adoption of MELT-300, starting with ophthalmic procedures and expanding into other outpatient settings.
Harrow, Inc. (Nasdaq: HROW) provides ophthalmic disease management solutions in North America, offering products for various eye conditions. More information about Harrow can be found at harrow.com.
Contacts:
Investors:
Mike Biega
Vice President of Investor Relations and Communications
mbiega@harrowinc.com
617-913-8890
Media:
Silvana Guerci-Lena
Powers & Company
silvana@powers-co.com
508-808-8993
Source: Harrow
