Harrow, Inc. announced it has officially completed the new drug application (NDA) transfer of TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL in the United States.
Let’s start with some background.
Back in January 2023, Harrow announced it had acquired the exclusive U.S. rights to five FDA-approved branded ophthalmic products from Novartis.
Among those was TRIESENCE, as well as:
- Ilevro (nepafenac ophthalmic suspension) 0.3%
- Nevanac (nepafenac ophthalmic suspension) 0.1%
- Vigamox (moxifloxacin hydrochloride ophthalmic suspension) 0.5%
- Maxidex (dexamethasone ophthalmic suspension) 0.1%
As part of the $175 million deal, Novartis would continue to sell the products in the U.S. market for 6 months (during which Harrow received all net profits).
After this grace period, Harrow would then take complete control of U.S market dealings and begin the process of having third-party manufacturers for the products.
So what’s happened with the other four products?
Harrow has steadily (and subsequently) completed the NDA transfers and commercially launched these products in the United States:May 2023 → Ilevro, Nevanac, Maxidex (coverage here)July 2023 → Vigamox (coverage here)
Gotcha. Now talk about TRIESENCE.
The ophthalmic product is a synthetic corticosteroid indicated for the treatment of the following:
- Sympathetic ophthalmia
- Temporal arteritis
- Uveitis
- Ocular inflammatory conditions unresponsive to topical corticosteroids + visualization during vitrectomy
What else should I know?
This transfer was completed ahead of the companies’ previously agreed NDA date—a significant step toward advancing Harrow’s strategy to relaunch TRIESENCE under its company umbrella, according to CEO Mark L. Baum.
“Our team has begun to implement our market access, marketing, inventory management, national sales detailing, and other brand-leveraging strategies,” he stated, “so that we will be ready to re-launch TRIESENCE in the U.S. once we have achieved a successful inventory build.”
So no timeline on when this will be available?
No specific timeline, as of now. But stay tuned!
When it is available, where will I find it?
As with Harrow’s other ophthalmic products, product orders can be made directly through Cardinal’s Cordlogistics (3PL Distribution Services)— its customer service ordering partner—which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.
Now the bigger picture.
This achievement for the company is just the latest update in Harrow’s continuing efforts to expand its ophthalmic portfolio and hold a dominant position within the ophthalmic pharmaceutical industry in the U.S. market.
See here for a look at its recent acquisitions and launches.