Glaukos has signed a new license agreement with Santen Pharmaceutical for the Preserflo MicroShunt, obtaining exclusive rights for the therapy in Australia, New Zealand and other territories.
Under the new agreement, Glaukos – an ophthalmic medical technology and pharmaceutical company focused on novel therapies for glaucoma, corneal disorders and retinal diseases – has obtained commercialisation rights for the MicroShunt in the US, Australia, New Zealand, Canada, Brazil, Mexico and the remainder of Latin America. The therapy is yet to received Therapeutic Goods Administration approval.
The updated deal supersedes the previous collaboration and distribution agreements between the two entities.
The Preserflo MicroShunt is a late-stage glaucoma treatment performed via an ab-externo approach. The system helps drain eye fluid and reduces 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.
It consists of a proprietary, biocompatible material called SIBS [poly(styrene- block-isobutylene-block-styrene)], and 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.
The new agreement also provides Glaukos with full control over all development activities in these same territories, including all clinical development and regulatory activities in the US following a transition period. Santen, a Japan-based firm, submitted a premarket approval (PMA) application to the US Food and Drug Administration (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,” Mr Thomas Burns, Glaukos president and CEO, said.
“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 organisation to bring this novel technology to patients who may need it.”
Santen will continue to manufacture and supply the MicroShunt for the Glaukos territories and lead development and commercialisation activities elsewhere. Financial terms of the new agreement were not disclosed.