Glaukos (NYSE:GKOS) announced that it entered into a new development and commercialization license agreement with Santen Pharmaceutical.
San Clemente, Calif.-based Glaukos’ agreement with Santen Pharmaceutical supersedes the previous collaboration and distribution agreements between the two parties over Santen’s Preserflo MicroShunt, according to a news release. Financial terms of the deal were not disclosed.
Santen designed its Preserflo MicroShunt as an ab-externo drainage system for draining eye fluid and reducing intraocular pressure (IOP) in patients with primary open-angle glaucoma whose IOP is not controlled when using maximum tolerated glaucoma medications or where glaucoma progression warrants surgery.
The Preserflo MicroShunt, a flexible, 8.5 mm-long tube, uses planar fins to help fixate the device in the tissue through a micro-incision while also preventing leakage and migration, the companies said.
Under the new agreement, Glaukos obtained exclusive commercialization rights for the Preserflo MicroShunt in the U.S., Australia, New Zealand, Canada, Brazil, Mexico and the remainder of Latin America.
Additionally, Glaukos received full control over all development activities for the device in the same territories. Santen submitted a premarket approval application to the FDA in June 2020 and said discussions with the regulatory body remain ongoing.
Santen will continue to manufacture and supply the device for the territories taken over by Glaukos, while also leading development and commercialization efforts elsewhere.
“We are excited to expand our agreement with Santen for the MicroShunt, supporting our goal to bring this important late-stage glaucoma technology to ophthalmic surgeons and patients,” Glaukos president & CEO Thomas Burns said in the release. “We believe there is a strong appetite within the global ophthalmic community for the MicroShunt as a more elegant, ab-externo alternative to conventional filtration surgeries for late-stage glaucoma management.
“We are excited for the opportunity to leverage our best-in-class sales organization to bring this novel technology to patients who may need it.”