Harrow (Nasdaq: HROW) announced on September 26, 2025, that it has entered into an agreement to acquire Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company developing non-opioid, non-IV therapies for procedural sedation. The acquisition, subject to customary closing conditions including Melt stockholder approval, brings Harrow the promising sedation therapy MELT-300 and positions the company to enter the multi-billion-dollar U.S. procedural sedation market.
MELT-300 Demonstrates Clinical Superiority
MELT-300 is a patented, sublingually delivered formulation containing a fixed dose of midazolam (3mg) and ketamine (50mg) designed to provide rapid, predictable sedation and analgesia without intravenous administration. The therapy addresses the healthcare system's growing demand to reduce opioid exposure while maintaining effective procedural sedation.
In November 2024, Melt announced positive topline results from its pivotal LOUISE (Lower Opioid Use and Improve the Sedation Experience) Phase 3 Study. The study demonstrated that MELT-300 was statistically superior to both sublingual midazolam alone (P=0.009) and placebo (P=<0.0001) in providing successful procedural sedation. Additionally, the proportion of patients requiring rescue sedation was nearly twice as high for sublingual midazolam compared with MELT-300 (P=0.003).
The LOUISE Phase 3 Study was conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), which confirmed the study design would adequately support a future regulatory submission. Results from a recently completed cardiac safety study indicated that MELT-300 did not alter normal heart rhythm, supporting the therapy's safety profile.
Regulatory Timeline and Market Strategy
Harrow plans to submit a New Drug Application (NDA) to the FDA in 2027, with a potential U.S. commercial launch in 2028. The company's strategic rationale for the acquisition centers on several key factors that position MELT-300 for immediate market impact.
Through its ImprimisRx subsidiary, Harrow has successfully marketed MKO Melt, a compounded sublingual sedation product widely used by ophthalmologists for more than a decade. The product has been used in over 500,000 cataract surgeries by over 700 U.S. ophthalmologists, providing a strong foundation of physician trust and market familiarity with sublingual sedation delivery. Upon FDA approval of MELT-300, Harrow intends to ensure customer access to an FDA-approved product and discontinue the MKO Melt.
Broad Market Opportunity
MELT-300's novel formulation has the potential to replace and/or supplement IV sedation in medical interventions, with applications extending far beyond ophthalmic surgery. The therapy could address tens of millions of procedures annually, including claustrophobia during MRIs, sedation for colonoscopies, dental procedures, gastroenterology procedures, and other interventions.
The therapy utilizes Catalent's ZYDIS oral dissolving tablet technology, which is used in over 35 FDA-approved products, offering a less invasive, needle-free, non-opioid option that could reduce anxiety, improve comfort, and simplify care. This approach enables physicians to perform procedures comfortably in office and outpatient settings, reducing reliance on operating rooms.
Harrow's existing commercial and regulatory infrastructure provides the scale to accelerate Melt's market introduction and potential to replace opioid-based intravenous sedation during the more than 4,000,000 annual U.S. cataract surgeries.
Global Expansion Potential
The MELT-300 product candidate has patents issued in North America, Australia, Europe, Asia, and the Middle East. Harrow intends to identify suitable development and commercialization partners to make this technology available outside the U.S. market, expanding the therapy's global reach.
Leadership Perspectives
"We are excited to welcome Melt Pharmaceuticals back into the Harrow family. This acquisition represents another important step in our mission to deliver innovative, patient-focused ophthalmic disease management solutions that go beyond the limitations of traditional care," said Mark L. Baum, Chief Executive Officer of Harrow. "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."
Larry Dillaha, MD, Chief Executive Officer of Melt Pharmaceuticals, added, "Sedation hasn't changed much over the past few decades. Having demonstrated the clinical superiority of the MELT-300 drug candidate over its individual components, including midazolam, we believe the standards of care for sedation will change when the MELT-300 drug candidate is FDA-approved."
The acquisition strengthens Harrow's perioperative portfolio of surgical solutions and diversifies the company's business as MELT-300 is utilized outside of its core U.S. ophthalmic business, positioning Harrow to transform the procedural sedation landscape with a non-opioid alternative that addresses critical public health needs.
