Melt Pharmaceuticals announced positive topline results from its Phase 3 study of MELT-300, a sublingual tablet for IV- and opioid-free procedural sedation in patients undergoing cataract surgery. The study demonstrated that MELT-300 was statistically superior to both sublingual midazolam and sublingual placebo in providing successful sedation, potentially transforming the patient experience and surgical workflow.
MELT-300: A Novel Approach to Cataract Surgery Sedation
MELT-300 is a fixed-dose combination of midazolam 3 mg and ketamine 50 mg, administered as a sublingual tablet using Catalent’s Zydis delivery technology. The tablet is designed to dissolve rapidly, facilitating absorption of the active ingredients across the sublingual mucosa. This innovative approach aims to eliminate the need for intravenous (IV) access and opioid analgesics, addressing a significant source of anxiety for many patients undergoing cataract surgery.
Phase 3 Trial Results
The pivotal Phase 3 trial randomized 530 patients across 13 clinical sites in the U.S. to receive either MELT-300, sublingual midazolam, or sublingual placebo. The results showed that MELT-300 achieved statistically superior sedation compared to sublingual midazolam (P = .009) and placebo (P < .001). Furthermore, the need for rescue sedation was nearly twice as high in the sublingual midazolam group compared to the MELT-300 group (P = .003), highlighting the enhanced efficacy of the combination therapy.
The safety profile of MELT-300 was found to be comparable to that of placebo, indicating a favorable risk-benefit ratio for this novel sedation approach.
Clinical Significance and Future Directions
According to Larry Dillaha, MD, CEO of Melt Pharmaceuticals, MELT-300 represents a “transformative step forward in procedural sedation for patients during cataract surgery.” He emphasized that avoiding IVs and opioids can alleviate patient anxiety and streamline the surgical process for both patients and providers.
"For many patients, the most anxiety-inducing aspect of the procedure is the insertion of an IV and the use of opioids," Dillaha said.
Melt Pharmaceuticals believes that MELT-300 has the potential to become a new standard of care in procedural sedation, starting with cataract surgery and expanding to other applications through strategic lifecycle management. The company recently closed $24 million in Series B financing to support the development of MELT-300 and its potential expansion into other procedural sedation settings.
