Santen Pharmaceutical and Glaukos have entered a multi-year agreement where Glaukos will be the exclusive distributor of Santen’s MicroShunt in the U.S. The financial details of the deal were not disclosed.
“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,” Shigeo Taniuchi, president and chief operating officer at Santen, said in a press release. “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.”
The MicroShunt is a minimally-invasive, ab-externo surgical device that is designed for primary open-angle glaucoma. It is currently being studied in an FDA pivotal trial for intraocular pressure in patients who have primary open-angle glaucoma.
“We expect Santen’s MicroShunt to complement our expanding portfolio of ab-inferno MIGS products by providing glaucoma patients with this ab-externo alternative to conventional filtration surgeries,” Thomas Burns, Glaukos president and CEO, said. “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.”
The agreement states that Glaukos will be the exclusive distributor of the MicroShunt in the U.S. market, dependent on U.S. regulatory approval. Santen will be responsible for marketing activities and maintaining responsibility for all aspects of MicroShunt’s manufacturing, quality and safety controls, regulatory activities, lifecycle management and post-approval marketing requirements.