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. The sedative uniquely combines a fixed dose of midazolam (3 mg) and ketamine (50 mg) in one tablet that is administered sublingually using Catalent’s proprietary Zydis delivery technology. Dissolving in as little as 3 seconds, this delivery technology allows absorption of the active ingredients across the sublingual mucosa, according to a company press release.

The randomized, double-blind, three-arm Phase 3 study compared, at a 4:1:1 ratio, MELT-300, sublingual midazolam, and sublingual placebo, respectively, for procedural sedation in patients undergoing cataract surgery. According to the company, topline results showed:

• MELT-300 was statistically superior compared to both sublingual midazolam (P=0.009) and placebo (P<0.001) for providing successful procedural sedation
• The proportion of patients requiring rescue sedation was nearly two-Fold higher for sublingual midazolam compared with MELT-300 (P=0.003)
• MELT-300 had a favorable safety profile that was generally comparable to placebo.

The Phase 3 study was conducted at 13 clinical sites in the United States and enrolled more than 530 patients. Based on a Special Protocol Assessment agreement reached with the FDA earlier this year, this study design and positive results support the necessary objectives required for a regulatory submission, said the company in a press release.

Principal investigator George Magrath, MD, said, “These Phase 3 data show the superiority of the combination of midazolam and ketamine compared with midazolam alone. If approved, I believe MELT-300 will be a safe and effective alternative to current sedation methods used for cataract surgery. As an ophthalmologist, I am excited about the prospect of using MELT-300 to enhance the overall experience for my cataract surgery patients.”