Glaukos Corporation Company Profile

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Item

Description

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Company Name

Glaukos Corporation

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Website

www.glaukos.com

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Established Date

1998

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Headquartered

California, United States

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Market Position/ History

Glaukos Corporation, founded in 1998, focuses on Micro-Invasive Glaucoma Surgery (MIGS) with its first commercial device in 2012, revolutionizing glaucoma treatment. It achieved significant milestones with the 2015 IPO, and FDA approvals for its iStent and iDose TR technologies. Key events include acquiring Avedro in 2019, receiving a permanent J-code for iDose TR in 2024.

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Sales Area

North America, South America, Europe, Africa, Asia-Pacific

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Manufacturing Location

California, United States

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Ticker

NYSE: GKOS

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No. of Employees

907 employees (As of December 31, 2023) 

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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

Thomas W. Burns

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Ownership Type

Public

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Contact Information

One Glaukos Way, Aliso Viejo, CA 92656, United States

Tel: +1-949-367-9600

Product

Product Description

iStent inject W

iStent inject W is a cutting-edge micro-invasive glaucoma surgery (MIGS) device designed to be used in conjunction with cataract surgery. It targets the reduction of intraocular pressure (IOP) in adult patients with mild to moderate primary open-angle glaucoma (POAG). This innovative device continues the legacy of excellence established by over 20 years of iStent technology, offering an advanced solution backed by extensive clinical evidence.

Key Features:

• Technology: Utilizes trabecular micro-bypass technology with two multi-directional stents to restore natural outflow pathways through the trabecular meshwork and Schlemm’s canal.
• Design: Each stent is one of the smallest medical implants and is engineered for precise placement and optimal outflow. The stents are designed to span five to six clock hours, re-establishing flow in dormant channels.
• Clinical Validation: Supported by over 200 peer-reviewed publications and a robust body of clinical evidence. It is considered the gold standard in micro-invasive glaucoma surgery (MIGS) and maintains a safety profile similar to cataract surgery alone.
• Procedural Benefits: Provides predictability and precision, is minimally invasive, and reduces postoperative care requirements to those similar to cataract surgery.

Specifications:

• Device Type: Trabecular micro-bypass stent
• Stents: Two stents per device
• Placement: Two to three clock hours apart
• Mechanism of Action: Creates patent bypass pathways through the trabecular meshwork to facilitate multi-directional aqueous outflow.
• Size: One of the smallest medical devices implanted in the human body
• Safety Profile: Comparable to cataract surgery alone
• Visual and Placement Aid: Includes a streamlined injector system with a next-generation stent design featuring a wide flange for enhanced visualization and placement accuracy.
• Postoperative Care: Designed to minimize trauma to eye tissue and conjunctival tissue, reducing the risk of hypotony by utilizing natural episcleral venous pressure.

Optimized Outcomes:

• Micro-invasive and astigmatically neutral: Minimizes impact on the eye and preserves natural anatomy for future treatment options.
• Enhanced Surgical Experience: Streamlined design and advanced features ensure confident delivery and increased procedural predictability.

iDose TR

The iDose TR (travoprost intracameral implant) 75 mcg is an innovative, long-duration pharmacological device designed to manage intraocular pressure (IOP) in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). As a groundbreaking treatment option, iDose TR is the first long-duration, anchored intracameral implant for the continuous delivery of travoprost, a prostaglandin analog, directly into the anterior chamber of the eye.

Key Features:

• Continuous Therapy: Delivers a proprietary formulation of travoprost continuously for long-term IOP control, reducing the need for frequent medication administration.
• Long-Term Efficacy: Demonstrated effectiveness in maintaining IOP control with significant reductions in the need for topical medications.
• Safety Profile: Proven safety and patient tolerability in clinical trials, with a well-established track record of managing potential adverse effects.

Specifications:

• Product Type: Intracameral implant
• Drug: Travoprost
• Dosage: 75 mcg
• Administration: Delivered via a sterile, single-dose inserter
• Technology:
  • Biocompatible Material: Designed to be well-tolerated and integrated within the eye
  • Proprietary Membrane: Ensures consistent, long-term drug elution
  • Anchored Design: Fixed and stabilized by anchoring into the scleral tissue to maintain optimal positioning

Clinical Efficacy:

• Pivotal Trials: iDose TR has demonstrated non-inferiority to topical timolol through 3 months, achieving long-term IOP control.
• 12-Month Outcomes: 81% of iDose TR patients were completely free of IOP-lowering topical medication at 12 months.

Safety Profile:

• Common Ocular Adverse Reactions (2% to 6% incidence):
  • Increases in IOP
  • Iritis
  • Dry eye
  • Visual field defects
  • Eye pain
  • Ocular hyperemia
  • Reduced visual acuity
• No Reported Adverse Events:
  • Clinically significant endothelial cell loss
  • Periorbital fat atrophy
  • Serious corneal adverse events (e.g., Descemet's Stripping Automated Endothelial Keratoplasty [DSAEK], Descemet's Membrane Endothelial Keratoplasty [DMEK])

Innovative Design:

• Preloaded Inserter: Allows for a straightforward and sterile implantation process.
• Scleral Anchoring: Ensures stability and prevents dislocation or migration of the implant.

PRESERFLO MicroShunt

The PRESERFLO MicroShunt is an advanced, Health Canada-approved device designed to manage primary open-angle glaucoma (POAG). It is a small, flexible stent made from a biocompatible, degradation-resistant material known as SIBS. The device is engineered to help reduce intraocular pressure (IOP) by facilitating the drainage of excess fluid from the eye, thus preventing further vision loss.

Key Features:

• Permanent Solution: Provides a long-lasting option for IOP control, helping to drain excess fluid from the eye.
• Minimally Invasive: Implanted through a less invasive outpatient surgical procedure, typically under local anesthesia.
• Effective IOP Reduction: Consistently lowers IOP to an average of ≤ 15 mmHg, as demonstrated in multiple clinical studies.
• Safety Profile: Designed to offer a safer surgical option with low rates of post-operative complications and interventions.

Specifications:

• Material: SIBS (a biocompatible, degradation-resistant polymer)
• Device Type: Subconjunctival glaucoma drainage device
• Design:
  • Insertion: One end of the MicroShunt is positioned in front of the iris where excess fluid accumulates.
  • Drainage: The other end is placed under the clear membrane (conjunctiva) to facilitate fluid drainage.
• Procedure: Outpatient surgery with local anesthesia; less invasive compared to traditional glaucoma surgeries.

Clinical Outcomes:

• 12-Month Results:
  • Medication-Free: 72% of patients were free from glaucoma medications.
  • Reduced Surgical Visits: 39% fewer additional surgical visits required within 12 months of implantation.

Pre-Surgery Preparation:

• Medication Adjustments: Your surgeon may instruct you to stop or start certain medications before the procedure.
• Safety Measures: Arrange for someone to accompany you home post-surgery.

Post-Surgery Care:

• Common Symptoms: Blurry vision, eye redness, and swelling may occur but typically resolve within the first week.
• Recovery Instructions: Use prescribed eye drops and avoid rubbing the eye or engaging in strenuous activities during the initial recovery period.

Safety Information:

• Typical Surgical Risks: Potential risks include reactions to medications, eye pain, inflammation, vision changes, increased or decreased eye pressure, and corneal swelling.
• Post-Operative Monitoring: Regular follow-up with your eye surgeon is essential to ensure effective IOP control. Additional treatments or medications may be required if IOP is not adequately controlled.

iStent infinite Trabecular Micro-Bypass System Model iS3

The iStent infinite Trabecular Micro-Bypass System Model iS3 is an implantable, micro-invasive glaucoma device designed for patients with primary open-angle glaucoma (POAG) who have not achieved sufficient control of intraocular pressure (IOP) through previous medical or surgical treatments. This device can be utilized both as a standalone treatment or in combination with cataract surgery, offering a versatile solution for managing difficult glaucoma cases.

Key Features:

• Standalone or Combined Use: Can be used independently or alongside cataract surgery to enhance IOP management.
• Micro-Invasive Technology: Designed as a micro-invasive alternative to traditional glaucoma treatments, addressing patient non-compliance and progressive disease effectively.
• Restores Physiologic Outflow: Features a multidirectional stent design to create arcs of flow spanning up to 8 clock hours (240°) in Schlemm’s canal, maximizing outflow and minimizing tissue disruption.
• Elegant Design: Utilizes a precision-engineered injector system to implant three wide-flange, anatomically designed stents.

Specifications:

• Device Type: Trabecular micro-bypass stent system
• Model: iS3
• Number of Stents: Three
• Design:
  • Stents: Multidirectional, anatomically designed with a wide flange for optimal placement and stability.
  • Coverage: Occupies approximately 3% of Schlemm’s canal, allowing 97% of the canal to remain untouched and preserving natural anatomy.
  • Arc of Flow: Designed to span up to 8 clock hours (240°) of Schlemm’s canal to enhance aqueous humor drainage.

Clinical Benefits:

• Long-Term IOP Control: Provides continuous, long-term management of IOP, demonstrating sustained efficacy in clinical trials.
• Versatility: Effective for patients with prior treatment failures, whether used alone or in combination with cataract surgery.
• Safety Profile: Safety comparable to cataract surgery alone, with a low risk of adverse events.

Procedural Features:

• Injector System: Precision-engineered for ease of implantation, ensuring accurate placement of the three stents across 180° of Schlemm’s canal.
• Micro-Invasive: Minimizes disruption to natural eye anatomy, reducing recovery time and postoperative complications.

iStent Trabecular Micro-Bypass Stent System Model GTS100

The iStent Trabecular Micro-Bypass Stent System Model GTS100 is a state-of-the-art intraocular device designed to manage intraocular pressure (IOP) in patients with primary open-angle glaucoma (POAG). This micro-invasive stent is used to create a patent opening in the trabecular meshwork to restore natural aqueous outflow and reduce IOP.

Key Features:

• Material: Manufactured from titanium (Ti6Al4V ELI), which is known for its biocompatibility and durability.
• Coating: Coated with stearalkonium heparin derived from porcine sources, which helps in reducing clot formation and enhancing biocompatibility.
• Design: Features a single-piece design, with a snorkel length of 0.25 mm and a nominal snorkel bore diameter of 120 μm.
• Stent Dimensions:
  • Length: 1.0 mm
  • Height: 0.33 mm
  • Snorkel Length: 0.25 mm
  • Snorkel Bore Diameter: 120 μm

Year

Latest News

Dec. 15, 2023

Glaukos' iDose TR Implant Receives FDA Approval

On Dec. 15, 2023, Glaukos Corporation's iDose TR implant, a drug-releasing device for glaucoma, received FDA approval. This implant, delivering travoprost for up to three years, aims to address noncompliance with eye drops. Despite approval for single-use only and a higher-than-expected cost of $13,950 per implant, the device's innovation is seen as potentially transformative for glaucoma treatment.

May 18, 2021

Glaukos Expands PRESERFLO™ MicroShunt Agreement with Santen

Glaukos Corporation has secured exclusive commercialization rights for the PRESERFLO™ MicroShunt in the U.S., Australia, Canada, and Latin America under a new agreement with Santen. This expansion gives Glaukos full control over development and regulatory activities in these regions, while Santen will continue manufacturing and supporting other markets.