Glaukos Corporation [NYSE: GKOS] declared that it has signed a development and commercialization license agreement with Santen Pharmaceutical Co., Ltd. (Santen) for the PRESERFLO MicroShunt. This new agreement is the substitute for earlier partnership and distribution agreements between the two parties.
As per the agreement, Glaukos receive special commercialization rights for the MicroShunt in New Zealand, Canada, Brazil, Mexico, the US, and Australia the rest of Latin America. Furthermore, this new agreement also provides GKOS full control over all development activities for the MicroShunt in these same areas. It involves overall clinical development and regulatory affairs activities in the US after a transition period.
Additionally, Santen also lodged a premarket approval (PMA) application to the U.S. FDA in June 2020, and negotiations with the FDA are underway. Santen will continue to produce and supply the MicroShunt for the Glaukos areas and lead development and marketing activities somewhere else. The firm has not yet revealed the financial terms of the agreement.
The PRESERFLO MicroShunt is an ab-externo, a drainage system. It assists in the drain of eye fluid. It also lessens IOP in sufferers with primary open-angle glaucoma whose IOP is not controlled when using maximum tolerated glaucoma medications or where glaucoma progression warrants surgery. To reduce glaucoma and vision loss only thing which works is to reduce IOP.