Harrow Health Acquires Patented Ophthalmic Surgical Drug Candidate from Sintetica
Summary
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) AMP-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. 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. Based in Mendrisio, Switzerland, Sintetica is a growing privately held international pharmaceutical company focused on analgesics, local anesthetics and sterile injectable solutions in ampoules, vials and IV bags for hospitals. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include the impact of the COVID-19 pandemic and any future health epidemics on our financial condition, liquidity and results of operations; our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; market acceptance of the Company’s formulations and challenges related to the marketing of the Company’s formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions.