Harrow Health Inc (HROW) saw its stock surge 5.04% in the pre-market session on Wednesday, following positive topline results from the Phase 3 clinical trial of MELT-300, a non-opioid sedative drug being developed by Melt Pharmaceuticals, a company spun off from Harrow in 2019.

The Phase 3 study evaluated the safety and efficacy of MELT-300, a sublingual tablet combining midazolam and ketamine, for procedural sedation during cataract surgery. The results demonstrated that MELT-300 was statistically superior to both sublingual midazolam and placebo in providing successful sedation, with a favorable safety profile comparable to placebo.

According to Melt Pharmaceuticals CEO Larry Dillaha, these positive results support a potential regulatory submission to the FDA for MELT-300's approval. If approved, MELT-300 could offer a safe and effective non-IV, non-opioid alternative to current IV-based sedation protocols involving opioids for cataract surgeries, which are expected to exceed 5 million annually in the coming years in the U.S.