Glaukos announced that it has entered into a new development and commercialization license agreement with Santen Pharmaceutical for the Preserflo MicroShunt (development code: DE-128), superseding the previous collaboration and distribution agreements between the two parties.
Financial terms of the new agreement were not disclosed.
Under the new agreement, Glaukos obtains exclusive commercialization rights for the MicroShunt in the United States, Australia, New Zealand, Canada, Brazil, Mexico and the remainder of Latin America. The new agreement also provides Glaukos with full control over all development activities for the MicroShunt in these same territories, including over all clinical development and regulatory affairs activities in the United States following a transition period. Santen submitted a premarket approval (PMA) application to the FDA in June 2020 and discussions with the FDA remain ongoing.
“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,” Thomas Burns, Glaukos president and chief executive officer, said in a company news 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.”
The Preserflo MicroShunt is an ab-externo, drainage system that helps drain eye fluid and reduces 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. IOP reduction is the most effective means of preventing the progression of glaucoma and vision loss. Made of a proprietary, biocompatible material called SIBS [poly(styrene-block-isobutylene-block-styrene)], the Preserflo MicroShunt is a flexible, 8.5-mm-long tube with planar fins to help fixate the device in the tissue through a micro-incision and prevent leakage and migration.
Santen will continue to manufacture and supply the MicroShunt for the Glaukos territories and lead development and commercialization activities elsewhere.