Harrow plans to acquire (or, more accurately, reacquire) Melt Pharmaceuticals, Inc., the company announced late last week.
Let's start with Melt.
Headquartered in Brentwood, Tennessee, the clinical-stage pharmaceutical company is developing and commercializing a pipeline of patented non-intravenous (IV), non-opioid, sedation, and analgesic therapeutics for short-term medical procedures.
These therapeutics: Encompass a series of combination non-opioid sedation drug formulations comprising its core technology of “procedural sedation” during:
- Cataract surgery
- Procedures with mild-to-moderate pain
- Panic attacks and other acute anxiety conditions
- Acute mild-to-moderate pain management
Learn why the company is focusing on this combination.
Explain this reacquisition component, please.
Melt was previously a subsidiary of Harrow (back when it was Harrow Health) until January 2019, when it spun out as a separate company.
Gotcha. So … why reacquire the company?
A major incentive is Melt’s lead investigational therapy: MELT-300.
What it is: A patented formulation encompassing a fixed dose of midazolam (3 mg) and ketamine (50 mg) via a dissolvable tablet delivered sublingually (under the tongue).
- Take note: This delivery is enabled via Zydis (Catalent Inc.), a proprietary, fast-dissolving (in as little as 3 seconds) platform that allows for absorption across the sublingual mucosa (and is reportedly already utilized in 30+ FDA-approved products).
And where does the ophthalmic component come into play?
MELT-300’s purpose is to serve as a safe and effective alternative to current IV-based sedation protocols for cataract surgery.
In general, the company is looking to use this “procedural sedation” to help patients tolerate potentially painful medical procedures (like cataract surgery) and decrease their perceptions of pain.
- See here for how patients’ tolerance is assessed
Speaking of assessments, how has MELT-300 performed clinically so far?
It’s quite promising, to say the least.
The most recent data were topline phase 3 clinical findings reported in November 2024 from the randomized, double-blind three-arm Lower Opioid Use and Improve the Sedation Experience (LOUISE) study.
What to know: MELT-300 demonstrated a favorable safety profile and was statistically superior in comparison to both sublingual midazolam (p = 0.009) and a placebo (p < 0.001) in providing successful procedural sedation.
- See here for our coverage (including how it compared to prior phase 2 safety and efficacy results).
What else to know?
Most notably, the LOUISE trial was conducted under a special protocol assessment (SPA) with the FDA—and its design was confirmed to "adequately support a future regulatory submission.”
Is there a specific timeframe for this yet?
In its Melt acquisition announcement, Harrow reported its intent to submit a new drug application (NDA) by 2027 and a (potential) subsequent U.S. commercial launch in 2028.
Nice! And how does MELT-300 complement Harrow’s existing portfolio?
The company offered an extensive list of “strategic rationale” supporting its move to (re)purchase Harrow and its portfolio.
Among those:
- Accretive launch opportunity—most notably, Harrow’s ImprimisRx subsidiary already has a compounded sublingual sedation product in use for cataract surgeries that the company plans to discontinue after MELT-300 is approved
- Market opportunity, specifically for ophthalmic surgery applications, and potential label expansion into other non-ophthalmic procedures
- Added diversification—a bonus to its existing perioperative portfolio of surgical solutions)
- Expanded accessibility for surgeons to perform procedures in-office and in outpatient settings
- Global application benefits, as the MELT-300 candidate has already secured patents issued in North America, Australia, Asia, and the Middle East
See the full rationale here.
Lastly, when is this deal expected to close?
Great question.
The acquisition—which, we must note, has no publicly disclosed monetary amount attached to it yet—has no timeline as yet.
- Per Harrow: “The closing of this acquisition is subject to customary closing conditions, including approval by Melt stockholders, excluding Harrow and Harrow-affiliated parties.”
So you know what that means—stay tuned!