Harrow completes acquisiton of Melt Pharmaceuticals

Harrow has completed the acquisition of Melt Pharmaceuticals, which includes product candidates MELT-210, MELT-300, and MELT-400 based on the Zydis ODT (oral dissolving tablet) drug delivery platform.

Melt will now be fully integrated into Harrow’s operations to ensure a “seamless transition and accelerate progress toward NDA submission, approval, and market launch” of MELT-300.

MELT-300 is a patented, sublingually delivered formulation of a fixed dose of midazolam (3 mg) and ketamine (50 mg) designed to provide rapid, predictable sedation without the need for intravenous administration. Previously, MELT-300 demonstrated statistical superiority to midazolam alone in phase 2 and phase 3 programs.

Mark L. Baum, CEO of Harrow, commented on MELT-300, saying, “The development of MELT-300 marks a defining milestone for Harrow—our first product taken from ideation to the brink of commercialization. I still remember the first call we received about this novel concept of non-IV, non-opioid sedation and the immediate sense that it could truly change the patient experience for procedural sedation.”

“We’re incredibly excited about MELT-300’s potential to transform procedural sedation, reduce opioid exposure, and expand safe, accessible sedation options across medical specialties. It’s not just a scientific or commercial achievement—it’s a meaningful step forward for patients and for the US healthcare system,” Baum concluded.

Commenting on MELT-210, Amir Shojaei, chief scientific officer at Harrow, added, “MELT-210 is a sublingual dosage of midazolam (3 mg) in the Zydis ODT technology and has been studied in both phase 2 and phase 3 trials as a comparator drug in the MELT-300 program. Due to the advantageous characteristics of MELT-210, including its rapid uptake and short half-life, compared to current market alternatives, we believe MELT-210 will have strong commercial potential. We look forward to engaging with FDA to discuss next steps for this advanced drug development program and, in due course, to have a second product in the market from the Melt portfolio.”

Additionally, Harrow announced what the next steps for MELT-300 will be following its phase 3 program. Harrow will be initiating 1 non-clinical animal study and 3 PK studies to generate the balance of the data necessary for an NDA package, which the company intends to submit in the first half of 2027. The company notes that it hopes to have a potential approval by the FDA in the first half of 2028 with a commercial launch in the second half of 2028.

Harrow's other moves in 2025

Earlier this year, Harrow entered into an agreement in which Harrow secured the exclusive US commercial rights to the ophthalmology biosimilar portfolio of Samsung Bioepis—ranibizumab-nuna 0.05 mL injection (BYOOVIZ), an FDA-approved biosimilar referencing LUCENTIS (ranibizumab), and aflibercept-yszy 0.05 mL injection (OPUVIZ), an FDA-approved biosimilar referencing EYLEA (aflibercept).

The commercial license will become effective upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected to be completed by the end of 2025, according to Samsung Bioepis.

Previously, BYOOVIZ was commercialized by Biogen in the US since its initial launch in June 2022. However, in October 2024, Biogen notified Samsung Bioepis of its decision to terminate the 2019 Development and Commercialization Agreement within the US and Canada.

Additionally, Harrow acquired the exclusive US commercial rights to clobetasol propionate ophthalmic suspension 0.05% (BYQLOVI) from Formosa Pharmaceuticals.

With that new deal with Harrow, Formosa terminated an agreement with Eyenovia due to “suspended sales of BYQLOVI due to corporate setbacks related to other programs.”

According to a news release from Formosa, Harrow expects BYQLOVI to be commercially available in the fourth quarter of 2025.

References:

1. Harrow Announces Closing of Acquisition of Melt Pharmaceuticals. Published November 18, 2025. Accessed November 18, 2025. https://www.harrow.com/news-releases/news-release-details/harrow-announces-closing-acquisition-melt-pharmaceuticals

2. Harp MD. Harrow enters into agreement with Samsung Bioepis for commercial rights to its ophthalmology biosimilar portfolio. Published July 17, 2025. Accessed November 18, 2025. https://www.ophthalmologytimes.com/view/harrow-enters-into-agreement-with-samsung-bioe-for-commercial-rights-to-its-ophthalmology-biosimilar-portfolio

3. Harp MD. Formosa Pharmaceuticals grants Harrow commercial rights in US to clobetasol propionate ophthalmic suspension 0.05% (BYQLOVI), terminates deal with Eyenovia. Published June 12, 2025. Accessed November 18, 2025. https://www.ophthalmologytimes.com/view/formosa-pharmaceuticals-grants-harrow-us-commercial-rights-to-clobetasol-propionate-ophthalmic-suspension-0-05-byqlovi-terminates-deal-with-eyenovia