Harrow completes transfer of Triesence NDA

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Harrow announced the completion of the transfer to Harrow of the New Drug Application (NDA) triamcinolone acetonide injectable suspension (Triesence) 40 mg/mL, a synthetic corticosteroid indicated for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids as well as visualization during vitrectomy.

In January of 2023, Harrow acquired the US commercial rights to Triesence. Aside from the transfer of the Triesence NDA ahead of the date previously agreed to, all other acquisition terms remain unchanged.¹

“While we continue to diligently work with our contract manufacturing partner, making solid progress manufacturing commercial batches of Triesence, the mutual agreement to an early transfer of the Triesence NDA was an important step in advancing our strategy to re-launch the product under the Harrow umbrella,” Mark L Baum, CEO of Harrow, said in the company’s news release. “With this crucial process completed, our team has begun to implement our market access, marketing, inventory management, national sales detailing, and other brand-leveraging strategies so that we will be ready to re-launch Triesence in the US once we have achieved a successful inventory build, which we are currently working diligently towards. We remain excited to be able to provide Triesence to the US ophthalmic community soon.”

About Triesence

Triesence suspension is a synthetic corticosteroid indicated for:

• Treatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.
• Visualization during vitrectomy.

DOSAGE AND ADMINISTRATION

• Initial recommended dose for all indications except visualization: 4 mg (100 microliters of 40 mg/mL suspension) with subsequent dosage as needed over the course of treatment.
• Recommended dose for visualization: 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension) administered intravitreally.

DOSAGE FORMS AND STRENGTHS

• Single use 1 mL vial containing 40 mg/mL of triamcinolone acetonide suspension.

CONTRAINDICATIONS

• Patients with systemic fungal infections.
• Hypersensitivity to triamcinolone or any component of this product.

For complete product information about Triesence is available online.

According to the company, Triesence is among the 5 products that Harrow purchased from Novartis in January of 2023 and for which Harrow has been receiving net profits from unit sales during the NDA transfer process.

In January, Harrow announced the closing of its acquisition of the exclusive US commercial rights to the five branded ophthalmic products.²

According to the news release at the time, Harrow said it expects these products to be immediately financially accretive and reaffirms 2023 guidance of $135 million to $143 million in net revenues and $44 million to $50 million in adjusted EBITDA.

When the agreement was announced last December, Baum pointed out that the deal places the company among the leaders in the US ophthalmic pharmaceuticals market.

“Following the satisfaction of the relevant closing conditions, these products will be immediately accretive to our revenues and excellently complement our current portfolio of ophthalmic prescription products,” Baum said earlier this year. “We know these products very well and have long appreciated and admired them for the value they have delivered to thousands of U.S. eyecare professionals and many millions of their patients.”

References:

1. Harrow completes transfer of the Triesence New Drug Application (2023) Business Wire. Available at https://www.businesswire.com/news/home/20231129601830/en/Harrow-Completes-Transfer-of-the-TRIESENCE%C2%AE-New-Drug-Application. Published November 29, 2023. Accessed November 29, 2023

2. Hutton, D. (2023a) Harrow launches trio of Ophthalmic Therapeutics in US, Ophthalmology Times. Available at: https://www.ophthalmologytimes.com/view/harrow-launches-trio-of-ophthalmic-therapeutics-in-us Published May 2, 2023. Accessed November 29, 2023.