Glaukos (NYSE:GKOS) said last Friday that it inked a multi-year distribution deal with Santen Pharmaceutical (OTC:SNPHY) to market its MicroShunt device, intended to reduce intraocular pressure in patients with primary open-angle glaucoma (POAG), in the U.S.
Through the deal, San Clemente, Calif.-based Glaukos will become the exclusive U.S. distributor of the MicroShunt, which is being studied in an FDA pivotal trial exploring its ability to reduce intraocular pressure in patients with POAG where intraocular pressure is uncontrolled with maximum tolerated medical therapy or where disease progression warrants surgery.
“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. We strongly believe that this partnership will bring MicroShunt, if approved, to physicians and patients in the United States in the most timely, efficient and effective way possible,” Santen prez & COO Shigeo Taniuchi said in a prepared statement.
Osaka, Japan-based Santen’s MicroShunt is a novel, minimally-invasive ab-externo device. Santen is aiming to complete its FDA premarket approval submission for the device this year, with a hoped for product launch next year.
While Glaukos will take over sales and distribution responsibilities for the device, Santen will retain marketing, manufacturing and other life-cycle management and post-approval requirements. Neither company released financial details of the agreement.
“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. We are enthusiastic about the opportunity to leverage our best-in-class sales organization and established commercial presence to partner with Santen and bring this novel technology to the United States if approved by the FDA,” Glaukos prez & CEO Thomas Burns said in a press release.
Earlier this month, Glaukos said that a study of its iStent trabecular micro-bypass stents showed reduced eye pressure in glaucoma patients and a reduction in needed add-on medications after five years.