Santen Announces Health Canada Approval of PRESERFLO MicroShunt

TORONTO--(BUSINESS WIRE)--Santen Canada Inc., a subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on ophthalmology, today announced the approval of PRESERFLO^TM MicroShunt by Health Canada. PRESERFLO MicroShunt is a surgical device that helps to drain eye fluid and reduce intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG) whose IOP is not controlled when using maximum tolerated glaucoma medications.

“This approval for PRESERFLO MicroShunt is a significant milestone in Santen’s aim to preserve vision by bringing new innovation to glaucoma surgery for patients in Canada, and advances our growth in the North American market,” said Carol Stiff, Head of Santen Canada Inc. “With this approval, we’re thrilled to bring the benefits of PRESERFLO MicroShunt to the Canadian market and to be able to offer a new surgical option for doctors and patients, shown to provide sustained reductions in IOP.”

A leading cause of blindness, glaucoma affects an estimated 79.6 million people worldwide.^1,2

“As a glaucoma specialist, I am extremely excited to learn of the approval of the PRESERFLO MicroShunt,” said Ike Ahmed, M.D., University of Toronto, Ontario. “This device, with its unique material and design, combines a minimally invasive approach with significant IOP-lowering and a more predictable postoperative course for our glaucoma patients in Canada."

About PRESERFLO MicroShunt

PRESERFLO MicroShunt is an ab-externo, drainage system that helps drain eye fluid and reduces IOP in patients with POAG whose IOP is not controlled when using maximum tolerated glaucoma medications [and/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)], 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. PRESERFLO MicroShunt is currently also available in Europe.

For more information and instructions, please consult the product labelling, including packaging and inserts.

About Santen

As a global specialized company dedicated exclusively to ophthalmology, Santen brings a 130-year history of scientific knowledge and organizational capabilities to research, development, and commercialization of pharmaceuticals, surgical and medical devices, and OTC eye-care products. Santen is the market leader for prescription ophthalmic pharmaceuticals in Japan and its products now reach patients in more than 60 countries. Santen provides products and services to contribute to the well-being of patients, their loved ones and consequently to society. For more information, please visit Santen’s websites www.santencanada.ca and www.santenusa.com (North America headquarters).

About InnFocus, Inc.

InnFocus, Inc. is a Santen subsidiary and the PRESERFLO MicroShunt medical device license holder in Canada.

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¹ Glaucoma Research Foundation. Glaucoma Facts and Stats. Available at https://www.glaucoma.org/glaucoma/glaucoma-facts-and-stats.php. Accessed August 22, 2019.
² Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006;90(3):262-267. doi:10.1136/bjo.2005.081224.