Live In Play

Live In Play®

Updated: 27-Jul-21 07:02 ET

HROW: Harrow Health has entered into an agreement with Sintetica to acquire the marketing and supply rights in the U.S. and Canada for AMP-100, a patented ophthalmic surgical drug candidate (8.50)

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.
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. Sintetica intends to submit a New Drug Application to the U.S. Food and Drug Administration 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.
Under the terms of the agreement, Sintetica will be responsible for regulatory filings for the product in the U.S. The agreement provides for upfront and milestone payments to Sintetica as well as per unit royalties on sales of AMP-100, when successfully commercialized. Harrow Health will have marketing rights for the U.S. and Canada, while Sintetica will retain the marketing rights in other countries.