Santen Pharmaceutical’s US subsidiary and Glaukos have entered into collaboration and distribution agreement for exclusive distribution of MicroShunt (DE-128) in the US market.
As part of the deal, Glaukos will exclusively supply MicroShunt to the customers in the US.
MicroShunt is a novel, minimally-invasive and ab-externo surgical device, which has been designed for primary open-angle glaucoma (POAG).
MicroShunt is being assessed in a pivotal trial of the US Food and Drug Administration (FDA) for intraocular pressure (IOP) reduction in patients with POAG where intraocular pressure is uncontrolled with maximum tolerated medical therapy or where the progression of the disease warrants surgery.
Santen intends to seek US FDA PMA following anticipated completion of the premarket approval (PMA) submission in this year. The company plans to launch the products in the US in 2020, if approved.
Santen president and COO Shigeo Taniuchi said: “Santen is very excited to partner with Glaukos whose proven surgical glaucoma expertise and established distribution and sales infrastructure in the United States are unparalleled.
Upon US regulatory approval, Glaukos will take responsibility for sales and distribution of MicroShunt in the US.
Santen will oversee marketing activities, as well as takes responsibility for all aspects of the product’s manufacture, quality and safety controls, regulatory activities, life-cycle management and post-approval marketing requirements.
MicroShunt, which is made by using biocompatible material called SIBS [poly(styrene-block-isobutylene-block-styrene)], is the first glaucoma device to be compared head-to-head with trabeculectomy in a randomized, masked, multicenter study.
MicroShunt was commercialized under CE mark in Europe as InnFocus MicroShunt. It is currently under the process of rebranding under the new global commercial name of Preserflo MicroShunt.
Glaukos president and CEO Thomas Burns said: “We expect Santen’s MicroShunt to complement our expanding portfolio of ab-interno MIGS products by providing glaucoma patients with this ab-externo alternative to conventional filtration surgeries.”
Santen is involved in the research, development, marketing, and sales of pharmaceuticals, over-the-counter products, and medical devices for ophthalmic applications.
Glaukos is an ophthalmic medical technology and pharmaceutical company involved in the development and commercialization of novel surgical devices and sustained pharmaceutical therapies.