Business
Harrow Completes Transfer of the TRIESENCE® New Drug Application
NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to
About this update from Harrow, Inc.
[{"type":"text","content":" NASHVILLE, Tenn.--(BUSINESS WIRE)--\nHarrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the completion of the transfer to Harrow of the New Drug Application (NDA) for TRIESENCE® (triamcinolone acetonide injectable suspension) 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 agreed to acquire the U.S. 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.\n\n\n“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,” said Mark L. Baum, Chief Executive Officer of Harrow. “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 U.S. 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 U.S. ophthalmic community soon.”\n\n\nAbout TRIESENCE® (triamcinolone acetonide injectable suspension) 40 mg/mL:\n\n\nHIGHLIGHTS OF TRIESENCE PRESCRIBING INFORMATION\n\n\nINDICATIONS AND USAGE\n\n\nTRIESENCE suspension is a synthetic corticosteroid indicated for:\n\n\n\nTreatment of the following ophthalmic diseases: sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.\n\n\n\nVisualization during vitrectomy.\n\n\n\nDOSAGE AND ADMINISTRATION\n\n\n\nInitial 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.\n\n\n\nRecommended dose for visualization: 1 to 4 mg (25 to 100 microliters of 40 mg/mL suspension) administered intravitreally.\n\n\n\nDOSAGE FORMS AND STRENGTHS\n\n\nSi...