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Harrow Health Acquires Patented Ophthalmic Surgical Drug Candidate from Sintetica
New Drug Application Expected to Be Filed in Late 2021 NASHVILLE, Tenn. & MENDRISIO, Switzerland--(BUSINESS WIRE)-- Harrow Health, Inc. (NASDAQ: HROW), an
About this update from Harrow, Inc.
[{"type":"text","content":"\nNew Drug Application Expected to Be Filed in Late 2021\n\n NASHVILLE, Tenn. & MENDRISIO, Switzerland--(BUSINESS WIRE)--\nHarrow Health, Inc. (NASDAQ: HROW), an ophthalmic‑focused healthcare company, today announced that it has entered into an agreement with Sintetica, S.A., a growing pharmaceutical company focused on analgesics, local anesthetics and sterile injectable solutions, to acquire the marketing and supply rights in the U.S. and Canada for AMP-100, a patented ophthalmic surgical drug candidate. When approved, AMP-100 will provide ocular surface anesthesia during ophthalmic interventions such as cataract surgery and intravitreal injections, which are estimated to total over 10 million procedures annually in the U.S.(1)\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210727005107/en/\nAMP-100 is a patented, innovative ocular surface anesthetic drug candidate, with safety and efficacy supported by a robust pre-clinical and clinical program, including a recently completed Phase 3 study that successfully compared the efficacy and tolerability of AMP-100 to current standards of care. Sintetica intends to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in late 2021. When approved, the active ingredient used in AMP-100 will be the first approved use of this active ingredient in the U.S. ophthalmic market.\n\nCommenting on the acquisition, Mark L. Baum, CEO of Harrow Health, said, “This transaction reflects Harrow Health’s commitment to continued growth by adding new high-value products to our portfolio. The acquisition of rights to market and sell AMP-100 in the U.S. and Canada will further fortify our greatest commercial strength – providing thousands of U.S. eyecare professionals and their patients with novel ophthalmic surgical products. When approved, we expect to fully leverage our wholly owned, efficient, scalable, and tech-enabled ImprimisRx ophthalmic-focused commercial and distribution platform to market AMP-100 to our ‘front-of-the-eye-focused’ customer base, such as cataract and refractive surgeons. In addition, we intend to invest in expanding our commercial footprint to include retina-focused surgeons to fully leverage the market potential of AMP-100.”\n\n“We have a sound business strategy for commercializing our prom...