Harrow is relaunching TRIESENCE (triamcinolone acetonide injectable suspension) 40 mg/mL, a preservative-free synthetic corticosteroid indicated for visualization during vitrectomy and to treat ocular inflammatory conditions that are unresponsive to topical corticosteroids.
Start from the beginning.
We’ll take you back to January 2023, when Harrow acquired the exclusive U.S. rights to five FDA-approved branded ophthalmic products from Novartis.
Included in that $130 million (+$45 million due once TRIESENCE was commercially launched) deal was TRIESENCE as well as:
- Ilvero (nepafenac ophthalmic suspension) 0.3%
- Nevanec (nepafenac ophthalmic suspension) 0.1%
- Vigamox (moxifloxacin hydrochloride ophthalmic suspension) 0.5%
- Maxidex (dexamethasone ophthalmic suspension) 0.1%
The significance: Harrow secured a major foothold in the U.S. ophthalmic pharmaceutical market.
What happened after this acquisition?
Fast forward to November 2023, Harrow completed the new drug application (NDA) transfer for TRIESENCE—paving the way for the company to plan for a U.S. commercial launch.
Gotcha. Now, let’s talk more about this product.
Originally FDA approved in 2007 (under Alcon ownership, prior to being acquired by Novartis in 2010), TRIESENCE is an injectable suspension that appears as a white backdrop against the back of the retina, enabling a higher degree of visibility of the vitreous and pathologic membranes during vitrectomy.
- Its indications also include sympathetic ophthalmia, temporal arteritis, and uveitis.
The recommended dosage for indications excluding visualization is:
- 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment
And for visualization: 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension), administered intravitreally.
What’s significant about this launch?
Most notably, the availability of TRIESENCE comes 5+ years after the product’s placement on the FDA Drug Shortage List, as well as 2 years of inventory depletion, according to Harrow.
- To note: Drugs are often included on this list due to manufacturing and quality problems, delays, and discontinuations.
In the case of TRIESENCE: The drug (developed by Novartis) was in shortage due to manufacturing delays related to good manufacturing practice, as Harrow is the sole supplier (and currently the manufacturer).
Now the important question: Where can I order it?
According to Harrow, U.S. healthcare and eye care providers can purchase TRIESENCE (a J3300 injection) directly through major pharmaceutical specialty distributors such as:
- Beese Medical/Cencora
- McKesson Medical-Surgical
- Cardinal Health
Special note: Initial supplies of the product will be listed under:
- NDC 00078-0897-78
- NDC 82667-800-01
Any words from the company on the launch?
Harrow Chairman and CEO Mark L. Baum stated that achieving this launch required “rebuilding the entire TRIESENCE supply chain and involved a global collaboration between Harrow and technical experts from our partners around the world.”
- These collaborators—who assisted in reinventing the product’s manufacturing and analytical testing process—included teams in South America and Europe.
Lastly, what does this mean for clinical use?
Rishi Singh, MD, a vitreoretinal surgeon at the Cleveland Clinic Florida, emphasized the critical need for TRIESENCE in office-based and surgical procedures.
“It has long been a trusted, indispensable resource, and its absence has left many ophthalmologists and retina specialists without a reliable alternative,” he said.
John W. Kitchens, MD, a vitreoretinal surgeon at Retina Associates of Kentucky, echoed similar sentiments on its return.
“Its potent anti-inflammatory properties also play a critical role in managing severe ocular inflammatory conditions that don’t respond to topical treatments, reducing swelling, pain, and the risk of long-term damage,” he added.