Melt Pharmaceuticals, Inc., a clinical-stage pharmaceutical company and former subsidiary of Harrow, announced the dosing of the last patient in its pivotal Phase 3 study for MELT-300. This product candidate is a non-IV, non-opioid tablet designed for procedural sedation during cataract surgery. The completion of patient dosing marks a critical step in the clinical development process.
MELT-300 uniquely combines a fixed dose of midazolam (3mg) and ketamine (50mg) in a sublingual tablet, utilizing Catalent's Zydis delivery technology. The Phase 3 study was a randomized, double-blind, three-arm trial conducted at 13 clinical sites in the United States, enrolling over 530 patients. This milestone moves the product closer to potential regulatory submission.
Harrow maintains an equity interest in Melt Pharmaceuticals, making the progress of MELT-300 relevant to its overall portfolio. The product aims to offer a safe and effective alternative to current IV-based cataract surgery sedation protocols, which often involve opioids. The market for cataract surgeries in the U.S. is projected to exceed 5 million annually in the coming years.
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