Glaukos Stock

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.

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. The company is developing a portfolio of platforms to support ongoing pharmaceutical and medical device innovations. Products and product candidates for each of these platforms are designed to advance the standard of care through better treatment options across the areas of glaucoma, corneal disorders, such as keratoconus, dry eye and refractive vision correction, and retinal diseases, such as neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).

The company’s commercial solutions and development-stage product candidates include:

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;

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;

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 and other ocular surface diseases and disorders; and

proprietary micro-invasive, bio-erodible 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 AMD, DME, and RVO;

Recent Developments

On December 13, 2023, the company received FDA approval for iDose TR indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. iDose TR is an intracameral procedural pharmaceutical therapy designed to continuously deliver 24/7 therapeutic levels of a proprietary formulation of travoprost inside the eye for extended periods of time.

On October 16, 2023, the company entered into an Exclusive License Agreement (Stuart License Agreement) with Stuart Therapeutics, Inc. (Stuart), pursuant to which Stuart granted it an exclusive, worldwide license to develop and commercialize products incorporating certain of its owned or controlled technologies, including its ST-113 drug compound, that may be utilized to provide neuroprotection in glaucoma.

On July 17, 2023, the company entered into a collaboration and marketing agreement (Collaboration and Marketing Agreement) with Radius XR, Inc. (Radius), in which it became the exclusive sales agent to market, promote and solicit orders for the Radius XR wearable patient engagement and diagnostic system within the United States.

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 its three principal end markets within ophthalmology: glaucoma, corneal disorders and retinal diseases.

Glaucoma

Glaucoma is a group of eye diseases characterized by progressive, irreversible and largely asymptomatic vision loss in which elevated levels of IOP are often associated with optic nerve damage that can cause blindness. While some glaucoma patients do not experience an increase in IOP, it is widely considered a major risk factor in glaucoma’s progression, and reduction in IOP is the only clinically proven treatment for the disease. Elevated IOP occurs when aqueous humor is not circulating normally or properly draining from the front part of the eye. The company has three primary commercialized 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, approved by the U.S. Food and Drug Administration (FDA) that improve aqueous humor outflow and are inserted through the small corneal incision made during cataract surgery, and are designed to treat mild-to-moderate open angle glaucoma. The company’s iStent, a single stent device which reduces IOP by restoring the natural physiologic pathways for aqueous humor, obtained 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. 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 Australia, Brazil, Canada, Japan, the United Kingdom, and a majority of the European Union (EU) members, and other countries, even though reimbursement may not always be available for all such procedures.

In August 2022, the company received 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 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.

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 24/7 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.

The company’s glaucoma pipeline includes the following programs:

iStent infinite PMA pivotal Phase 3 clinical trial for the treatment of mild-to-moderate glaucoma;

iLution Travoprost Phase 2a clinical trial;

The second-generation extended release iDose TREX (pre-clinical); and

Future generations of the iDose platform (pre-clinical).

In addition to its organic R&D efforts noted, the company has licensed from 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 is working with the FDA to evaluate an alternate pathway for potential approval. As such the timing of a potential approval and U.S. commercial launch is unknown. The company has commercialized the PreserFlo MicroShunt in Australia and Canada beginning in 2021.

Corneal Disorders

The company’s pharmaceutical iLink platform uses a suite of novel single-use drug formulations that are bio-activated by its 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, is approved by the FDA for use in the U.S. following removal of the epithelium (often referred to as iLink epi-off), a procedure familiar to ophthalmologists. In February 2021, the company announced topline data for the Phase 3 trial 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). As a result of this Phase 3 trial, the company began to prepare for a new drug application (NDA) submission. However, in 2022, based on feedback from the FDA during the company’s pre-NDA submission meeting, it made the decision to commence a second confirmatory Phase 3 clinical trial for iLink epi-on to support a future NDA submission. The company commenced patient enrollment for this trial in the first quarter of 2023 and completed patient enrollment for this trial in the second quarter of 2023. The company is also advancing clinical trials for a third generation iLink therapeutic system. Internationally, its pharmaceutical therapies can also be administered with the KXL System to address corneal weakening caused by refractive surgery such as LASIK. The company is 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.

The company has also developed 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 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 ocular surface diseases and disorders. In January 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 January 2023, the company announced promising initial Phase 2a results for GLK-301. Additionally, in late 2023 the company commenced a Phase 2a trial for iLution Travoprost for use in glaucoma patients.

Lastly, 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.

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.

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, hospitals and physician private practices. In the U.S., the company sells the majority of its products through a direct sales organization. Internationally, the company sells its products primarily through direct sales subsidiaries and through independent distribution partners in certain countries. In 2023, sales to customers inside U.S. and internationally accounted for 70% and 30% of the company’s net sales, respectively. For the year ended December 31, 2023, the company’s iStent family of products, and related accessories, accounted for approximately 75% of its net sales, while its iLink therapies accounted for approximately 25% of its net sales.

Competition

In glaucoma, the company’s MIGS offerings primarily compete against Alcon, which acquired Ivantis Inc. in January 2022, Sight Sciences and New World Medical. The company’s procedural pharmaceutical product competes with AbbVie Inc. However, there are a considerable number of large and small companies providing other surgical glaucoma technologies, laser-based therapies, and pharmaceuticals. In corneal disorders, the company has the only FDA approved bio-activated pharmaceutical therapy for the treatment of keratoconus; however, there are certain pharmacies that compound pharmaceuticals that may be used by certain physicians in place of its Photrexa product, and globally it competes against numerous providers of corneal crosslinking therapies, such as PeschkeTrade GmBH. The company’s corneal disorder pipeline, if approved, would vastly expand its competition to numerous large companies, such as AbbVie Inc., Alcon and Johnson & Johnson, as well as some small companies that provide medical technology and pharmaceutical therapies for several areas including dry eye and refractive conditions.

Manufacturing and Distribution

In the United States, the company distributes 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.

Internationally, the company distributes its products using third-party logistics providers in the Netherlands, Germany, Japan, Australia, Canada and Brazil.

Intellectual Property

As of December 31, 2023, the company owned or exclusively licensed in certain fields of use over 400 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 Holdings, Inc., 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 2024 and 2042.

Research and Development (R&D)

The company’s R&D expenses for the year ended December 31, 2023, were $138.8 million.

Government Regulation

The development and commercialization of drug products is subject to extensive regulation by governmental authorities in the U.S. Before marketing in the U.S., a drug must undergo rigorous preclinical and clinical studies and an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug, and Cosmetic Act (FDCA). 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.

Before commencing clinical studies in humans in the U.S., the company must submit to the FDA an investigational new drug (IND) application that includes, among other things, the general investigational plan and protocols for specific human studies and the results of preclinical studies.

The company is also subject to various laws and regulations regarding laboratory practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances in connection with its research.

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 which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order, arrangement for, or recommendation of, items or services for which payment may be made, in whole or in part, under federal health care programs;

The federal civil False Claims Act prohibits, among other things, knowingly presenting or causing the presentation of a false or fraudulent claim for payment of government funds, or knowingly making, using, or causing to be made, a false record or statement material to a false or fraudulent claim to avoid, decrease or conceal an obligation to pay money to the federal government. False Claims Act liability is significant in the healthcare industry because the statute provides for treble damages and significant mandatory penalties per false claim or statement for violations (adjusted annually for inflation);

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 that went into effect January 1, 2023, the Virginia Consumer Data Protection Act and the Colorado Privacy Act. 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;

The Physician Payments Sunshine Act, which requires applicable manufacturers like the company to report annually to the CMS information related to payments and other transfers of value made to certain healthcare providers, including physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, and certified nurse-midwives, and teaching hospitals, and ownership and investment interests held by such healthcare providers and their immediate family members; and

Federal and state government price reporting laws that require the company to calculate and report certain drug pricing metrics to government programs, such as the average sales price of its Photrexa and iDose TR products, where such reported prices may be used in the calculation of reimbursement and/or discounts on its marketed pharmaceutical products, and prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs, including federal laws that require any company that participates in the Medicaid Drug Rebate Program (MDRP) also to participate in the Public Health Service's 340B drug pricing program (340B program) in order for federal funds to be available for the manufacturer's drugs under Medicaid and Medicare Part B.

The company’s Photrexa pharmaceutical therapy has received a permanent Healthcare Common Procedure Coding System (HCPCS) J-code that covers the cost of the drug. The company has also obtained temporary Category III CPT code for the professional fees associated with CXL procedures done in a physician office setting.

The company has applied for a HCPCS J-code for its iDose TR procedural pharmaceutical product. The company has already obtained a temporary Category III CPT code for the facility and professional fees associated with the implantation procedure of an iDose TR in an ASC setting.

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. The company’s 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.

History

Glaukos Corporation was founded in 1998. The company was incorporated in Delaware in 1998.