Glaukos Corporation operates as an ophthalmic pharmaceutical and medical technology company. The company focuses on developing novel, dropless therapies and commercializing associated products for the treatment of glaucoma, corneal disorders, and retinal disease.
The company first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012. In 2024, the company commenced commercialization...
Glaukos Corporation operates as an ophthalmic pharmaceutical and medical technology company. The company focuses on developing novel, dropless therapies and commercializing associated products for the treatment of glaucoma, corneal disorders, and retinal disease.
The company first developed Micro-Invasive Glaucoma Surgery (MIGS) as an alternative to the traditional glaucoma treatment paradigm, launching its first MIGS device commercially in 2012. In 2024, the company commenced commercialization activities for iDose TR, a first-of-its-kind, long-duration, intracameral procedural pharmaceutical implant designed to continuously deliver glaucoma drug therapy inside the eye for extended periods of time. The company also offers commercially a proprietary bio-activated pharmaceutical therapy for the treatment of a rare corneal disorder, keratoconus, that was approved by the United States (U.S.) Food and Drug Administration (FDA) in 2016. Beyond its approved products, the company continues to develop and advance a robust pipeline of novel, dropless platform technologies designed to meaningfully advance the standard of care and improve outcomes for patients suffering from chronic eye diseases.
The company has designed commercial and development-stage solutions to provide ophthalmologists and other eye care professionals with various treatment options.
The company’s commercial solutions and development-stage product candidates include procedural pharmaceuticals based on an intracameral drug delivery technology designed to reduce IOP by delivering therapeutic levels of glaucoma medication from inside the eye over an extended period of time; MIGS products that primarily involve the insertion of a micro-scale device designed to reduce intraocular pressure (IOP) by restoring the natural aqueous humor outflow pathways for patients suffering from glaucoma; bio-activated pharmaceuticals that are intended to strengthen, stabilize, and reshape the cornea for patients impacted by corneal ectatic disorders such as keratoconus or refractive disorders; transdermal pharmaceuticals that are applied to the eyelid and designed to treat glaucoma, dry eye, presbyopia, demodex blepharitis, and other ocular surface diseases and disorders; and proprietary micro-invasive, bio-erodible posterior sustained release drug delivery implants that are designed to elute pharmaceuticals over time to improve the vision of patients impacted by retinal diseases such as age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
Products and Pipeline
The company operates in one operating segment and its primary business activity is the development and commercialization of therapies across several end markets within ophthalmology. In an effort to provide greater visibility into its business, the following discussion is presented based on the company’s five principal novel platforms that address four therapeutic areas within ophthalmology: glaucoma, rare disease, anterior segment and posterior segment.
iStent Micro-Scale Surgical Devices
The company has three primary commercialized micro-scale surgical device products designed to treat glaucoma: the iStent, the iStent inject W, and the iStent infinite, collectively referred to as the iStent family of products.
The iStent and the iStent inject W are micro-bypass stents designed to treat mild-to-moderate open angle glaucoma through the restoration of the natural physiologic outflow pathways for aqueous humor. These stents are inserted through the small corneal incision made during cataract surgery and implanted in the trabecular meshwork of the eye. The company’s iStent, a single stent device which reduces IOP by restoring the natural physiologic pathways for aqueous humor, obtained U.S. FDA clearance in 2012 and was the first commercially available MIGS treatment solution. The iStent inject W device includes two stents pre-loaded in an auto-injection system designed to allow the surgeon to inject stents through a single corneal entry and was approved by the FDA in 2018. The iStent and iStent inject W procedures are reimbursed in the U.S. by Medicare and all major national private payors. Some or all of the iStent family of products are commercially available in numerous countries, including certain members of the European Union members, the United Kingdom, Japan, Australia, Canada and Brazil, and other countries.
In August 2022, the company received FDA 510(k) clearance for the iStent infinite indicated for use in the treatment of patients with glaucoma uncontrolled by prior medical and surgical therapy. The iStent infinite product includes three heparin-coated titanium stents preloaded into an auto-injection system that allows the surgeon to inject stents across a span of up to approximately six clock hours around Schlemm’s canal, the eye’s primary drainage channel. Once in place, the stents are designed to lower IOP by restoring the natural, physiological outflow of aqueous humor. iStent infinite is the company’s first FDA-cleared micro-bypass stent that can be used in either a standalone procedure or in conjunction with cataract surgery for glaucoma patients uncontrolled by prior medical and surgical therapy.
The company has also licensed from Santen Pharmaceutical Co., Ltd. (Santen) the PRESERFLO MicroShunt. The MicroShunt is an ab-externo device being developed for the treatment of glaucoma where IOP is uncontrolled with maximum tolerated medical therapy or where progression of the disease warrants surgery. Santen submitted a Pre-Market approval (PMA) application to the FDA in June 2020. In April 2022, the U.S. FDA completed its review for the MicroShunt PMA submission and notified InnFocus, Inc, a Santen company, of a Non-Approvable determination. The company then assumed clinical development from Santen and plans to commence a Phase 3 clinical trial for the PRESERFLO MicroShunt in 2025, which would be the basis to support potential future FDA approval in the future. The company has commercialized the PRESERFLO MicroShunt in various countries including but not limited to, Australia, Canada and Brazil.
iDose Sustained-Release Pharmaceuticals
In December 2023, the company received FDA approval for iDose TR, indicated for the reduction of IOP in patients with open-angle glaucoma or ocular hypertension. iDose TR is a first-of-its-kind, intracameral procedural pharmaceutical therapy designed to continuously deliver therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time. iDose TR is intended to improve the standard of care by addressing the ubiquitous patient non-compliance issues and chronic side effects associated with topical glaucoma medications.
iDose TR was initially launched in a controlled manner during the first quarter of 2024. Up until the beginning of the third quarter of 2024, iDose TR was reimbursed with Medicare under a miscellaneous C-code, and the company was in the process of securing both the establishment of a facility fee, as well as a physician fee payment. On March 21, 2024, the U.S. Centers for Medicare & Medicaid Services (CMS) assigned the temporary Current Procedural Terminology (CPT) codes 0660T and 0661T which are designed to cover the facility fee payment to ambulatory payment classification 5492, effective April 1, 2024. Then, on April 2, 2024, CMS assigned a unique, permanent
Healthcare Common Procedure Coding System (HCPCS) J-code that covers reimbursement for the iDose TR product. This J-code became effective on July 1, 2024. Lastly, for products like iDose TR that are covered by temporary CPT codes, the physician fee payment rates are set by the multi-state, regional contractors, or Medicare Administrative Contractors (MACs) that are responsible for administering Medicare claims. Throughout 2024, the company has been continuously working with the MACs to streamline and obtain consistent reimbursement payments for iDose TR related to the permanent J-code, the facility fee, and the physician fee.
iLink Bio-Activated Pharmaceuticals
The cornea is responsible for the majority of the eye’s total focusing power and corneal disorders, including ectasia, refractive vision errors and dry eye, among others, can cause vision impairment. Corneal ectatic disorders are consists of a class of diseases characterized by an ectatic, or misshaped, cornea. Corneal ectasia is typically caused by a weakening of the cornea, which can be due to a number of factors, including genetic causes, adverse side effects from ophthalmic refractive procedures such as LASIK, or excessive eye rubbing. The company is targeting corneal disorders with its bio-activated pharmaceuticals including keratoconus, a rare disease, and corneal ectasia following refractive surgery.
The company’s pharmaceutical iLink platform uses a suite of novel single-use drug formulations that are bio-activated by iits proprietary systems to address these corneal diseases. The iLink therapies, bioactivated upon the delivery of ultraviolet A (UVA) light to the cornea, induce a biochemical reaction called corneal collagen cross-linking (CXL). CXL strengthens, stabilizes and reshapes the cornea to treat corneal ectatic disorders.
The company’s KXL System, which delivers UVA light to a large portion of the cornea, in conjunction with its Photrexa therapy, was approved by the FDA in 2016 for use in the U.S. following removal of the epithelium (often referred to as iLink epi-off), a procedure familiar to ophthalmologists. In December 2024, the company announced submission of its New Drug Application (NDA) to the U.S. FDA for the iLink system using Epioxa therapy for the treatment of keratoconus without the removal of the epithelium (often referred to as iLink epi-on). The company anticipates an FDA approval decision for Epioxa by the end of 2025.
The company is also advancing clinical trials for a third generation iLink therapeutic system and are investigating whether its bio-activated pharmaceutical products may also offer a means of improving the vision of patients with presbyopia, myopia or other corneal diseases. Internationally, the company’s iLink pharmaceutical therapies can also be administered with the KXL System to address corneal weakening caused by refractive surgery, such as LASIK.
iLution Transdermal Pharmaceuticals
The company is developing its iLution platform of cream-based drug formulations that are applied to the outer surface of the eyelid for dropless transdermal delivery of pharmaceutically active compounds for the treatment of certain anterior segment eye disorders. Several iLution platform products leverage an exclusive global licensing arrangement with Intratus Inc. to research, develop, manufacture and commercialize a patented, non-invasive, transdermal drug delivery formulation designed for application on the eyelid in the treatment of dry eye disease, presbyopia, glaucoma, and other anterior segment ocular surface diseases and disorders.
In September 2021, the company entered into a licensing agreement with Attillaps Holdings, Inc. (Attillaps) to research, develop, manufacture and commercialize Attillaps’ proprietary library of investigational pharmaceutical compounds that target the eradication of Demodex mites, which are the root cause of Demodex blepharitis and often associated with meibomian gland dysfunction and related ophthalmic diseases. The company expects to commence a Phase 2 clinical trial evaluating iLution for the treatment of Demodex blepharitis by the end of 2025.
In late 2023 the company commenced a Phase 2a trial for iLution Travoprost for use in glaucoma patients. In 2022, the company commenced patient enrollment in Phase 2 clinical trials of two investigational drug candidates for the treatment of signs and symptoms of dry eye disease (GLK-301) and presbyopia (GLK-302). In 2023, the company announced topline initial Phase 2a results for GLK-301.
Retinal XR Bio-Erodable IVT Pharmaceuticals
The company’s research and development (R&D) efforts in its Retinal XR platform are focused on treating AMD, DME, RVO, and other posterior segment retinal diseases. The company is developing sustained release (SR) pharmaceutical retinal platforms leveraging its expanded pharmaceutical and sustained drug delivery R&D capabilities, including Triamcinolone Acetonide SR, Multi-Kinase Inhibitor SR and Anti-VEGF SR. In December 2023, the company commenced a first-in-human clinical trial for its retinal intravitreal multi-kinase inhibitor designed to treat wet AMD patients.
The focus of the company’s retinal research and development efforts is to develop potential treatment options with a longer duration-of-effect than current standards of care products.
Research and Development
The company’s research and development pipeline includes various programs such as iStent infinite PMA pivotal Phase 3 clinical trial for the treatment of mild-to-moderate glaucoma; iStent infinite MDR submission in the EU for advanced-refractory glaucoma; U.S. IDE for the PRESERFLO MicroShunt; Second-generation extended release iDose TREX Phase 2b/3 clinical program; Next generations of the iDose platform (pre-clinical); NDA submission of Epioxa (Epi-on); iLink third-generation Phase 2 clinical program; 2025 commencement of Phase 2 clinical trial for iLution Blepharitis; iLution Travoprost (GLK-311) Phase 2a clinical trial; iLution Dry Eye (GLK-301) Phase 2a clinical trial; iLution Presbyopia (GLK-302) Phase 2a clinical trial; IVT Multi-Kinase Inhibitor (GLK-401) Phase 2 clinical trial for AME, DME and RVO; and IVT NCE Conjugate (GLK-411) for DME (pre-clinical).
Sales and Marketing
The company’s global sales efforts and promotional activities are aimed at ophthalmic surgeons and other eye care professionals. The company’s primary customers include ambulatory surgery centers (ASC), hospitals and physician private practices. In the U.S., the company sells the majority of its products through a direct sales organization. Internationally, it sells its products primarily through direct sales subsidiaries. In 2024, sales to U.S. and international customers accounted for 70% and 30% of the company’s net sales, respectively. No single customer or distributor accounted for more than 10% of its total net sales in 2024. For the year ended December 31, 2024, the company’s iStent family of products, iDose TR, and related glaucoma accessories accounted for approximately 79% of its net sales, while its iLink therapies accounted for approximately 21% of its net sales.
Competition
In glaucoma, the company’s MIGS offerings primarily compete against Alcon, which acquired Ivantis Inc., Sight Sciences and New World Medical. The company’s procedural pharmaceutical product competes with AbbVie Inc. Globally the company competes against numerous providers of corneal crosslinking therapies, such as PeschkeTrade GmBH.
Facilities, Manufacturing and Distribution
In the U.S., the company distribute s its iStent family of products directly from its campus in San Clemente, California, or from a third-party distribution center located in Memphis, Tennessee. The company’s iDose TR and Photrexa products are distributed using third-party logistics providers. The company’s KXL Systems are distributed from its facility in Burlington, Massachusetts.
Internationally, the company distributes ots products using third-party logistics providers in the Netherlands, Germany, the United Kingdom, Japan, Australia, Canada and Brazil.
Research and Development (R&D)
The company’s R&D expenses for the year ended December 31, 2024, included $136.4 million.
Intellectual Property
As of December 31, 2024, the company owned or exclusively licensed in certain fields of use over 500 issued patents, pending U.S. patent applications, issued foreign patents and pending foreign patent applications. The company has obtained licenses from various parties, including Intratus, Inc., Attillaps., Iveena Delivery Systems, Inc. and Stuart Therapeutics, Inc. for patents, patent applications or other technology. The issued patents that protect the company’s commercial products and current product pipeline expire between 2025 and 2043.
Government Regulation U.S. Regulation & Reimbursement
Several of the company’s products, including its recently-approved iDose TR implants and its pipeline iLution cream-based formulations, are drug products that are subject to this regulatory approval process.
Additional laws and regulations also govern the company’s business operations and products in the U.S., including among others:
the federal health care Anti-Kickback Statute; the federal civil False Claims Act; federal and state laws and regulations that govern the collection, dissemination, security, use, disclosure, deletion and confidentiality of patient-identifiable health and other proprietary and personally-identifiable information, in particular, the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, as well as proposed or enacted state-level laws and regulations that create data privacy and security rights for state residents and obligations for certain entities, such as the California Consumer Privacy Act, the California Privacy Rights Act, the Virginia Consumer Data Protection Act and the Colorado Privacy Act, among other states. HIPAA created federal criminal statutes that prohibit, among other actions, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program; and the Physician Payments Sunshine Act.
The company’s operations and many of the products it manufactures or sells are subject to extensive regulation by numerous other governmental agencies, both within the U.S. and internationally. In the U.S., apart from the agencies discussed above, its facilities, operations, employees, products (their manufacture, sale, import and export) and services are regulated by the Environmental Protection Agency, the Occupational Health & Safety Administration, the Department of Labor, Customs and Border Protection, the Department of Commerce, the Department of Treasury, the Department of Justice and others. State agencies also regulate its facilities, operations, employees, products and services within their respective states. Government agencies internationally also regulate public health, product registration, manufacturing, environmental conditions, labor, exports, imports, bribery and corruption and other aspects of its global operations.
History
Glaukos Corporation was founded in 1998. The company was incorporated in Delaware in 1998.
