Harrow announced that it has entered into an agreement to acquire Melt Pharmaceuticals, a clinical-stage company developing sublingual, non-opioid sedation therapies. Melt’s lead candidate, MELT-300, combines midazolam and ketamine in a dissolvable tablet designed to provide rapid, predictable sedation without intravenous administration. The acquisition is subject to approval by Melt stockholders.

MELT-300 has been studied in the LOUISE phase 3 trial, which demonstrated statistical superiority over both sublingual midazolam and placebo for procedural sedation, with lower rates of rescue sedation. Conducted under a special protocol assessment with the US Food and Drug Administration (FDA), the trial’s design supports a future regulatory submission. A cardiac safety study also showed MELT-300 did not affect normal heart rhythm. Harrow expects to file a new drug application in 2027, with a potential US launch in 2028.

For ophthalmologists, the acquisition builds on Harrow’s experience with MKO Melt, a compounded sublingual sedative used in more than 500,000 cataract surgeries. Harrow plans to discontinue MKO Melt upon FDA approval of MELT-300, offering ophthalmologists an FDA-approved alternative. The company anticipates MELT-300 could play a role in the more than 4 million annual US cataract surgeries and extend into other medical procedures requiring sedation. Harrow also highlighted the potential for MELT-300 to reduce opioid exposure while expanding access to sedation in outpatient and office settings, positioning the product within the multi-billion-dollar procedural sedation market.