Glaukos Corporation

Glaukos Corporation (NASDAQ:GKOS) is a specialized ophthalmic medical technology and pharmaceutical company founded in 1998 and headquartered in San Clemente, California. The company went public in June 2015 and has established itself as a pioneer in minimally invasive glaucoma surgery (MIGS) and innovative ocular therapeutics. Glaukos focuses on developing and commercializing novel therapies for treating glaucoma, corneal disorders, and retinal diseases, with a particular emphasis on what it calls "interventional glaucoma" - a proactive approach to treating eye pressure and preventing vision loss before significant damage occurs.

Over the past few years, Glaukos has undergone a significant strategic transformation centered around its **"interventional glaucoma"** philosophy - treating glaucoma proactively rather than waiting for disease progression. The most significant development has been the **launch of iDose TR**, the company's first intracameral sustained-release drug delivery system that received FDA approval and began commercial launch in 2023. This product represents a paradigm shift from traditional daily eye drops to a single injection that can provide therapeutic levels of medication for extended periods. The company has systematically expanded its **training and market access programs** for iDose TR, growing from a controlled launch to broader commercial availability. Key milestones include securing a permanent J-code (J7355) for billing, methodically working with Medicare Administrative Contractors (MACs) to establish reimbursement coverage, and training hundreds of surgeons on the injection technique. The company has also been building clinical evidence with nine peer-reviewed publications supporting the technology. In the **pipeline development** area, Glaukos has advanced several key programs. The company submitted an NDA for **Epioxa**, a non-invasive corneal cross-linking therapy that could expand treatment options for corneal disorders. The **iDose TREX program** has progressed to Phase 2b/3 clinical trials, representing a potential next-generation sustained-release platform. The company has also commenced pivotal studies for the **PRESERFLO MicroShunt** and continued development of **iStent infinite** for standalone glaucoma procedures. Strategically, the company has been **investing in infrastructure and capabilities**, including plans for a new R&D and manufacturing facility in Huntsville, Alabama. The focus has shifted toward achieving **cash flow breakeven** while maintaining investment in the clinical pipeline, reflecting a more disciplined approach to capital allocation as the company matures.