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Santen and Glaukos enter MIGS distribution agreement

03/05/2019By Callum Glennen
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Japanese ophthalmic company Santen has entered into an agreement that will see Glaukos exclusively distribute the MicroShunt Minimally Invasive Glaucoma Surgery (MIGS) device throughout the US, assuming it passes US Food and Drug Administration (FDA) trials.

The device is currently the subject of an FDA trial to measure its effectiveness at reducing intraocular pressure in patients with primary open-angle glaucoma that is either uncontrolled with maximum tolerated medical therapy, or warrants surgery.

The MicroShunt is manufactured from a propriety biomaterial, and is the first glaucoma device to be compared head-to-head with trabeculectomy.

“Santen is very excited to partner with Glaukos whose proven surgical glaucoma expertise and established distribution and sales infrastructure in the United States are unparalleled,” Mr Shigeo Taniuchi, president and chief operating officer at Santen, said.

“We strongly believe that this partnership will bring MicroShunt, if approved, to physicians and patients in the United States in the most timely, efficient and effective way possible.”

Thomas Burns, Glaukos’ president and chief executive officer
Thomas Burns, Glaukos’ president and chief executive officer
“We are enthusiastic about the opportunity to leverage our best-in-class sales organisation and established commercial presence to partner with Santen and bring this novel technology to the United States if approved by the FDA”
Thomas Burns, Glaukos

Specialising in ophthalmology, Santen’s portfolio of products includes therapies for dry eye, glaucoma and age-related macular degeneration. In 2016 the company acquired Innfocus, the original developer of the MicroShunt. The device has been awarded a CE mark in Europe, and is currently in the process of being rebranded as the Preserflo MicroShunt.

A submission for premarket approval of the MicroShunt is expected to be completed in 2019. If successful, Santen plans to launch the device in 2020.

Assuming it receives US regulatory approval Glaukos will become responsible for sales and distribution of the MicroShunt, while Santen will be in charge of marketing, manufacturing, quality controls and regulatory activities. Financial terms of the agreement were not disclosed.

“We expect Santen’s MicroShunt to complement our expanding portfolio of ab-interno MIGS products by providing glaucoma patients with this ab-externo alternative to conventional filtration surgeries,” Mr Thomas Burns, Glaukos’ president and chief executive officer, said.

“We are enthusiastic about the opportunity to leverage our best-in-class sales organisation and established commercial presence to partner with Santen and bring this novel technology to the United States if approved by the FDA.”

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Glaukos is a pioneer in MIGS and launched its own device, the iStent, in 2012. The company also released the next-generation iStent inject, which it believes to be the smallest medical device ever approved by the FDA, in September 2018.

 

More reading:

Glaukos' iStent inject receives US FDA approval

 

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