Harrow Completes Transfer of the Triesence New Drug Application

Harrow announced the completion of the transfer to the company of the New Drug Application (NDA) for Triesence (triamcinolone acetonide injectable suspension) 40 mg/mL. Triesence is 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 agreed to acquire the United States 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.

“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 relaunch the product under the Harrow umbrella,” commented Mark L. Baum, Chief Executive Officer of Harrow, in the company’s press release.

Mr. Baum continued, “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 relaunch Triesence in the United States 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 United States ophthalmic community soon.”