Former Harrow unit Melt announces results for MELT-300 to sedate for surgery

Melt Pharmaceuticals announced positive topline results of its pivotal Phase 3 study evaluating the safety and efficacy of its lead product candidate, MELT-300, a non-IV, non-opioid tablet for procedural sedation during cataract surgery. Based on a Special Protocol Assessment agreement reached with the U.S. Food and Drug Administration earlier this year, this study design and these positive results support the necessary objectives required for a regulatory submission. George Magrath, M.D., a board-certified ophthalmologist and a MELT-300 Phase 3 study principal investigator, commented…In commenting on the topline results, Dr. Larry Dillaha, Chief Executive Officer of Melt, said, “We are extremely excited with this robust topline data from our pivotal Phase 3 study. These overwhelmingly positive results support our belief that MELT-300, if approved by the FDA, would be a safe and effective non-IV, non-opioid alternative to current IV-based cataract surgery sedation protocols, which generally involve the administration of opioids. With the number of cataract surgeries performed each year in the U.S. expected to exceed 5 million in the coming years, we believe offering patients and physicians the ability to achieve an adequate sedation level without the need to start an IV or administer opioids is a very attractive proposition.”