Santen Pharmaceutical Co., Ltd Company Profile

Sr. No.

Item

Description

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Company Name

Santen Pharmaceutical Co., Ltd.

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Website

www.santen.com

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Established Date

1890

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Headquartered

Osaka, Japan

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Market Position/ History

Founded in Osaka in 1890, Santen launched its first eye care product, "Daigaku Eye Drops," in 1899, addressing widespread eye health needs in Japan. In the 1950s, the company expanded into prescription pharmaceuticals and introduced innovative products for ophthalmology. By 1990, Santen began international expansion, entering the European market and expanding its product lineup. In the 2000s, Santen established a significant presence in Asia, including China and South Korea. Since 2010, Santen has focused on global growth and social innovation in eye health.

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Sales Area

Worldwide

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Manufacturing Location

China, Japan

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Ticker

TYO: 4536

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No. of Employees

3,744, as of Mar 31, 2024

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Competitors

• Alcon Inc
• AbbVie Inc
• Johnson & Johnson Vision Care, Inc
• ISTAR MEDICAL SA.
• BVI Medical, Inc.

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CEO

Takeshi Ito

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Ownership Type

Public

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Contact Information

Grand Front Osaka Tower A, 4-20 Ofuka-cho, Kita-ku, Osaka 530-8552, Japan

TEL: +81-6-7664-8621

Product

Product Description

InnFocus MicroShunt

The InnFocus MicroShunt is a cutting-edge minimally invasive glaucoma surgery (MIGS) device designed to manage intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). By facilitating the drainage of aqueous humor from the eye, the MicroShunt aims to reduce IOP effectively and prevent further progression of glaucoma and associated vision loss.

Device Specifications

• Material: The MicroShunt is constructed from SIBS (poly(styrene-block-isobutylene-block-styrene)), a highly biocompatible biomaterial that has a proven track record of use in the body for over 15 years. This material is known for its durability and compatibility with ocular tissues.
• Dimensions:
  • Length: 8.5 mm
  • Outer Diameter: 350 μm
  • Lumen Diameter: 70 μm
• Design Features:
  • Planar Fixation Fins: These multipurpose fins help secure the device in place, minimizing the risk of migration and leakage post-implantation.
  • Lumen Size: The 70-μm diameter lumen is specifically designed to reduce the risk of chronic hypotony (low IOP) and to prevent clogging, ensuring consistent and reliable fluid drainage.

Biocompatibility and Safety

• Preclinical Studies: Extensive research has been conducted using rabbit eyes to assess the biocompatibility and safety of the SIBS material compared to silicone controls. Key findings include:
  • Reduced Inflammation: The SIBS material demonstrated less inflammatory response and minimal scar tissue formation compared to silicone.
  • Biostability: The absence of biodegradation byproducts from SIBS contributes to reduced inflammation and improved long-term tissue compatibility.
  • Collagen Deposition: There was less collagen deposition around SIBS implants compared to silicone, which is crucial for reducing scar tissue and improving the long-term effectiveness of the device.
  • Myofibroblast Presence: Myofibroblasts, cells involved in scarring, were not observed around SIBS implants, while they were present around silicone implants.

Clinical Trials and Regulatory Status

• Clinical Trials: The MicroShunt is notable for being the first MIGS device to undergo a direct head-to-head comparative trial against trabeculectomy, a traditional glaucoma surgery. This large-scale, prospective, randomized, controlled, multicenter trial involves 527 patients across the US and Europe. The trial aims to evaluate the MicroShunt’s efficacy and safety in managing POAG where IOP remains uncontrolled despite the use of maximally tolerated glaucoma medications.
• Regulatory Approval: The MicroShunt received the CE Mark in 2012, allowing for its commercial availability in Europe. This regulatory milestone signifies that the device meets European standards for safety and performance in medical devices.

DE-128 (Microshunt)

DE-128, also known as MicroShunt, is an investigational minimally invasive glaucoma implant designed to manage intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). It is intended for individuals whose IOP remains inadequately controlled despite the use of maximally tolerated glaucoma medications. This device aims to provide effective IOP reduction to prevent the progression of glaucoma and associated vision loss.

Product Type

• Device Type: Investigational, minimally invasive, ab-externo surgical implant.

Function

• Primary Function: To lower intraocular pressure (IOP) by draining excess aqueous humor from the eye. This reduction in IOP is crucial for preventing further progression of glaucoma and preserving vision in patients with POAG whose condition is not controlled with maximum medical therapy.

Design and Material

• Material: The device is constructed from a proprietary, highly biocompatible material known as SIBS (poly(styrene-block-isobutylene-block-styrene)). SIBS is a durable material with a long history of safe use in the body.
• Dimensions:
  • Length: 8.5 mm
  • Outer Diameter: 350 μm
  • Lumen Diameter: 70 μm
• Design Features:
  • Planar Fins: The MicroShunt includes planar fins that facilitate secure fixation within the eye’s tissue. These fins help prevent leakage and device migration, ensuring stable positioning post-implantation.

Clinical Development

• Clinical Trials: DE-128 has been evaluated in clinical trials, including the INN-005 study. This prospective, randomized, controlled trial aimed to assess the efficacy of DE-128 in reducing IOP and decreasing the need for glaucoma medications. The trial results demonstrated significant reductions in IOP and a decrease in the requirement for additional glaucoma medications.
• Regulatory Status: The device is currently under review by the U.S. Food and Drug Administration (FDA). The FDA accepted the premarket approval (PMA) application for DE-128 in July 2020. This review process is crucial for determining the device's safety and efficacy before it can be approved for broader use in the U.S. market.

PRESERFLO MicroShunt

The PRESERFLO MicroShunt is a minimally invasive surgical device designed to manage intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). It is specifically intended for patients whose IOP is not adequately controlled with maximum tolerated glaucoma medications and/or where glaucoma progression indicates the need for surgical intervention.

Device Type

• Type: Ab-externo, minimally invasive drainage system.

Function

• Primary Function: To drain excess aqueous humor from the eye, thereby reducing intraocular pressure (IOP). Effective IOP control is critical for preventing further progression of glaucoma and minimizing the risk of vision loss.

Design and Material

• Material: The PRESERFLO MicroShunt is made from SIBS (poly(styrene-block-isobutylene-block-styrene)), a proprietary biocompatible material known for its flexibility and durability. SIBS has been used successfully in various medical applications for over 15 years, ensuring a high level of biocompatibility and performance.
• Dimensions:
  • Length: 8.5 mm
  • Outer Diameter: 350 μm
  • Lumen Diameter: 70 μm
• Design Features:
  • Flexible Tube: The device consists of a flexible tube designed to fit comfortably within the eye’s anterior chamber.
  • Planar Fins: The MicroShunt includes planar fins that secure the device in place within the eye. These fins help to stabilize the implant, minimizing the risk of leakage and migration post-surgery.
  • Micro-Incision: The device is implanted through a micro-incision, enhancing the minimally invasive nature of the procedure and contributing to a faster recovery.

Clinical Use and Availability

• Indications: PRESERFLO MicroShunt is indicated for patients with POAG whose IOP is not controlled with maximum tolerated glaucoma medications and/or in cases where progression of glaucoma warrants surgical intervention.
• Current Status: The PRESERFLO MicroShunt is available in Europe, where it is used in clinical practice. It has been introduced as a less invasive option compared to traditional glaucoma surgeries, potentially offering improved patient outcomes with fewer complications.

Year

Latest News

May 4, 2021

Santen Receives Health Canada Approval for PRESERFLO™ MicroShunt

Santen Canada has announced Health Canada approval for the PRESERFLO™ MicroShunt, a device designed to reduce intraocular pressure in patients with primary open-angle glaucoma. This approval marks a significant step for Santen’s growth in the North American market and offers a new surgical option for Canadian patients.

April 26, 2019

Santen and Glaukos Announce Exclusive U.S. Distribution Agreement for MicroShunt

Santen and Glaukos have entered into a multi-year agreement making Glaukos the exclusive distributor of the MicroShunt in the U.S. market, pending FDA approval. Santen will handle manufacturing, regulatory activities, and marketing, while Glaukos will manage sales and distribution.