Melt Pharmaceuticals has announced positive topline results from its Phase 3 clinical trial evaluating MELT-300, a novel sublingual tablet for procedural sedation during cataract surgery. The study, conducted under a Special Protocol Assessment agreement with the FDA, supports the regulatory submission of MELT-300 as a non-IV, non-opioid alternative for cataract surgery sedation.
Phase 3 Trial Details
The Phase 3 trial was a randomized, double-blind, three-arm study conducted at 13 clinical sites across the United States, involving over 530 patients. Participants were assigned in a 4:1:1 ratio to receive either MELT-300, sublingual midazolam, or a sublingual placebo. The primary endpoint was to evaluate the efficacy of MELT-300 for procedural sedation in cataract surgery.
MELT-300 combines a fixed dose of midazolam (3 mg) and ketamine (50 mg) in one tablet, administered sublingually using Catalent’s Zydris delivery technology. This technology allows the tablet to dissolve rapidly, facilitating absorption of the active ingredients across the sublingual mucosa.
Clinical Significance
According to Larry Dillaha, MD, CEO of Melt Pharmaceuticals, the overwhelmingly positive results support the belief that MELT-300, if approved by the FDA, would be a safe and effective alternative to current IV-based cataract surgery sedation protocols, which often involve opioids. With the number of cataract surgeries in the U.S. expected to exceed 5 million annually, MELT-300 offers an attractive proposition for patients and physicians seeking adequate sedation without IVs or opioids.
John Berdahl, MD, co-inventor of MELT-300 and board member of Melt Pharmaceuticals, noted that a proprietary compounded combination of midazolam and ketamine, which inspired MELT-300, has been used by hundreds of ophthalmologists in hundreds of thousands of cataract surgeries. He expressed excitement about the prospect of FDA approval, which he believes would enhance healthcare professionals' confidence in adopting this sedation method.
Future Implications
George Magrath, MD, a principal investigator in the Phase 3 study, highlighted that the data demonstrate the superiority of the midazolam and ketamine combination compared to midazolam alone. He anticipates that MELT-300, if approved, will be a safe and effective alternative to current sedation methods for cataract surgery, enhancing the overall patient experience.
Melt Pharmaceuticals aims to expand the potential use of MELT-300 to over 100 million annual procedures across various medical specialties, including dermatology, plastic surgery, dentistry, gastroenterology, and emergency care, through lifecycle management.
