Core Viewpoint - Harrow has completed the acquisition of Melt Pharmaceuticals, enhancing its portfolio with innovative non-opioid, non-IV sedation therapies for medical procedures, particularly in ophthalmology and outpatient settings [1][2][3] Company Overview - Harrow is a leading provider of ophthalmic disease management solutions in North America, focusing on safe, effective, and affordable medications to improve patient outcomes [7] Acquisition Details - The acquisition of Melt Pharmaceuticals marks a strategic expansion for Harrow, allowing entry into the multi-billion-dollar procedural sedation and anxiety market [2][3] - Melt's product candidates, including MELT-210 and MELT-300, utilize the proprietary Zydis® ODT drug delivery platform, which is designed for rapid and effective sedation [1][2] Product Development - MELT-300 is a sublingual formulation combining midazolam (3mg) and ketamine (50mg), showing statistical superiority to midazolam alone in clinical trials [3][5] - The MELT-300 program has received a Special Protocol Assessment (SPA) from the FDA, confirming its Phase 3 study design and endpoints for future regulatory submission [5][6] Future Steps - Harrow plans to submit the NDA for MELT-300 in the first half of 2027, with potential FDA approval expected in the first half of 2028 [9] - The company aims to leverage its existing commercial infrastructure to facilitate the launch of MELT-300, initially targeting cataract and other ophthalmic procedures [9]